Technical

reference guide

For DuPont™ Transition Tyvek® 1073B,

Transition Tyvek® 1059B and
Tyvek® 2FS™ — English units

October 2017
Contents
This document is not intended for use in the People’s Republic of China.

Section
1 Why is Tyvek® the preferred choice for sterile barrier systems? 9
Learn more about the science of protection with Tyvek ®
9
Tyvek®—origins and how it is made 10
At the forefront of technological and regulatory development 11
Sterile barrier systems (SBS) made of Tyvek ®
12
Tyvek® vs. medical-grade papers: a comparison of properties 13

2 Tyvek®—properties 20
Specification and miscellaneous properties of Tyvek ®
20
Differential scanning calorimetry (DSC) and infrared spectrum “fingerprinting” via ATR-FTIR 21
Tyvek® temperature resistance 23
Chemical resistance 24

3 Biocompatibility, food contact, pharmacopeia and bioburden 25

4 Sterilization compatibility 28
Ethylene oxide (EO) 28
Radiation 29
Steam 30
Low-temperature oxidative (STERRAD®, vaporized hydrogen peroxide) 31
Sterilization pouches and rolls intended for the healthcare sterilization market 32
Re-sterilization 33
Tyvek® sterilization compatibility—test results 33

5 Stability testing 38
Performance of Tyvek® after aging 38
Summary of the 5-year shelf-life test protocol 38
Results of 5-year real-time aging study after EO sterilization 39
Results of 1- and 7-year real-time aging study after gamma and electron beam 39
Results of 1-, 3-, 5-, 7- and 10-year accelerated aging study after different sterilization modalities 41
Results of 1-year real-time aging study after different sterilization modalities 44
Results of combined accelerated and real-time aging test after gamma sterilization (seal strength) 47

6 Package system performance testing 48

Mechanical properties 48
Transport simulation and subsequent testing 48
Storage requirements 48
Packaging exposed to liquid 48

Contents 2
Contents
Section

7 Application guidance 49
Guidelines for printing 49
Labeling 53
Heat sealing guidelines 53
The unique structure of Tyvek ®
54
Determining the rough vs. smooth side of Tyvek® 55
Package quality evaluation 57
Slitting of Tyvek ®
58
Processing/troubleshooting guidelines 58
Controlling static charges during converting operations 64
Recycling of Tyvek ®
64

Appendices

A1 Test methods and standards 65

A2 Methods for measuring properties 67
A3 Guide to some common industry acronyms 68
A4 References 69

This Technical reference guide is applicable to DuPont™ Transition Tyvek® 1073B and Transition Tyvek® 1059B, as well as Tyvek® 2FS™. In some cases, information based on data that
was generated on Legacy Tyvek® is presented. In those cases, this distinction is clearly indicated. Transition Tyvek® has been proven to be functionally equivalent to Legacy Tyvek®.
Legacy Tyvek® is either Tyvek® 1073B or Tyvek® 1059B produced on the original manufacturing lines. Transition Tyvek® is either Tyvek® 1073B or Tyvek® 1059B produced on the
newer manufacturing lines.

Note: There is a tremendous amount of data and information referenced in this document that can be viewed and downloaded by
clicking on the supplied links. Therefore, it is important to use this document while on a computer with access to the internet.

Contents 3
Contents
List of tables

I. Coefficient of friction (COF)—static/dynamic—Transition Tyvek® 1073B,

Transition Tyvek® 1059B and Tyvek® 2FS™ against 316 stainless steel (ASTM D1894) 24

II. Biocompatibility, food contact, pharmacopeia and bioburden

testing results for Transition Tyvek® 1073B and Transition Tyvek® 1059B 26

III. Biocompatibility, food contact, pharmacopeia and bioburden

testing results for Tyvek® 2FS™ 27

IV. Material compatibility with various sterilization modalities 28

V. Ethylene oxide (EO) sterilization details for

Tyvek® sterilization compatibility testing 28

VI. Gamma radiation sterilization details for

Tyvek® sterilization compatibility testing 29

VII. Electron-beam sterilization details for

Tyvek® sterilization compatibility testing 29

VIII. Steam sterilization details for

Tyvek® sterilization compatibility testing 30

IX. Low-temperature oxidative sterilization details for

Tyvek® sterilization compatibility testing 31

X. Effect of low-temperature oxidative sterilization on hydrostatic head

and surface energy—Transition Tyvek® 1073B and Transition Tyvek® 1059B 32

XI. Physical properties of Legacy Tyvek® sterilized by

ethylene oxide (EO) before and after 5-year real-time aging 39

XII. Real-time aging test results for Legacy Tyvek® 1073B and Legacy Tyvek® 1059B 40

XIII. Seal strength of Legacy Tyvek® 1073B after gamma

sterilization following accelerated and real-time aging 47

XIV. Test methods and standards 65

Contents 4
Contents
List of figures

1. Scanning electron micrographs (SEMs) of Tyvek® (500x magnification) 9

2. Pouches made with Tyvek® 12

3. Sterilization bag made with Tyvek® 12

4. Header bag made with Tyvek® 12

5. Flexible and rigid trays made with Tyvek® 12

6. Nested tub made with Tyvek® 12

7. Tyvek® vs. medical-grade papers: a comparison of properties 13

8. Particle penetration of porous sterile barrier materials (ASTM F2638—in % pMax) 14

9. Mullen burst properties of Tyvek® styles

and medical-grade papers (ISO 2758—in psi) 15

10. Elmendorf tear (MD) properties of Tyvek® styles and medical-grade

papers (ASTM D1424 and EN 21974—in lbf) 15

11. Elongation (MD) properties of Tyvek® styles and

medical-grade papers (EN ISO 1924-2—in %) 16

12. Hydrostatic head properties of Tyvek® styles and

medical-grade papers (AATCC TM 127 and EN 20811—in in. H2O) 17

13. Ethylene oxide (EO) residual concentration in porous sterile barrier materials
after sterilization and aeration for 6, 12, 24 and 48 hours (ISO 10993-7) 18

14. Particles generated by Transition Tyvek® 1073B, Transition Tyvek® 1059B and two commonly
used medical-grade papers (Gelbo Flex testing method, ISO 9073-10) 19

15. DSC curves for Transition Tyvek® 1073B and Transition Tyvek® 1059B 21

16. DSC curves for DTyvek® 2FS™ 21

17. IR curves for Transition Tyvek® 1073B and Transition Tyvek® 1059B
(including all line/polymer combinations) 22

18. IR curves for Tyvek® 2FS™ 22

Contents 5
Contents
List of figures

19. Dimensional study for Transition Tyvek® 1073B and Transition Tyvek® 1059B 23

20. Results of shrinkage tests and Gurley Hill porosity measurements conducted
on Transition Tyvek® 1073B and Transition Tyvek® 1059B after steam sterilization 30

21. Effects of sterilization on material tensile strength (MD) for Transition Tyvek® 1073B,
Transition Tyvek® 1059B and Tyvek® 2FS™ (ASTM D5034—in lb f/4 in.) 33

22. Effects of sterilization on material tensile strength (CD) for Transition Tyvek® 1073B,
Transition Tyvek® 1059B and Tyvek® 2FS™ (ASTM D5034—in lb f/4 in.) 34

23. Effects of sterilization on material elongation (MD) for Transition Tyvek® 1073B,
Transition Tyvek® 1059B and Tyvek® 2FS™ (ASTM D5034—in %) 34

24. Effects of sterilization on material elongation (CD) for Transition Tyvek® 1073B,
Transition Tyvek® 1059B and Tyvek® 2FS™ (ASTM D5034—in %) 35

25. Effects of sterilization on material puncture strength for Transition Tyvek® 1073B,
Transition Tyvek® 1059B and Tyvek® 2FS™ (ASTM F1342—in lb f) 35

26. Effects of sterilization on material microbial barrier for Transition Tyvek® 1073B,
Transition Tyvek® 1059B and Tyvek® 2FS™ (ASTM F2638—in % pMax) 36

27. Effects of sterilization on material microbial barrier for Transition Tyvek® 1073B
and Transition Tyvek® 1059B (ASTM F1608—in LRV) 36

28. Effects of sterilization on material color (L,a,b) for

Transition Tyvek® 1073B and Transition Tyvek® 1059B 37

29. Effects of sterilization and accelerated aging on material tensile strength (MD)
for Transition Tyvek® 1073B, Transition Tyvek® 1059B and Tyvek® 2FS™
(ASTM D5034—in lb f/4 in.) 41

30. Effects of sterilization and accelerated aging on material tensile strength (CD)
for Transition Tyvek® 1073B, Transition Tyvek® 1059B and Tyvek® 2FS™
(ASTM D5034—in lb f/4 in.) 41

31. Effects of sterilization and accelerated aging on material elongation (MD)

for Transition Tyvek® 1073B, Transition Tyvek® 1059B and Tyvek® 2FS™ (ASTM D5034—in %) 42

Contents 6
Contents
List of figures

32. Effects of sterilization and accelerated aging on material elongation (CD)

for Transition Tyvek® 1073B, Transition Tyvek® 1059B and Tyvek® 2FS™ (ASTM D5034—in %) 42

33. Effects of sterilization and accelerated aging on material puncture strength

for Transition Tyvek® 1073B, Transition Tyvek® 1059B and Tyvek® 2FS™
(ASTM F1342—in lb f/4 in.) 43

34. Effects of sterilization and accelerated aging on material microbial barrier

for Transition Tyvek® 1073B, Transition Tyvek® 1059B and Tyvek® 2FS™
(ASTM F2638—in % pMax) 43

35. Effects of sterilization and 1-year real-time aging on material tensile strength (MD)
for Transition Tyvek® 1073B and Transition Tyvek® 1059B
(ASTM D5034—in lb f/4 in.) 44

36. Effects of sterilization and 1-year real-time aging on material tensile strength (CD)
for Transition Tyvek® 1073B and Transition Tyvek® 1059B
(ASTM D5034—in lb f/4 in.) 44

37. Effects of sterilization and 1-year real-time aging on material elongation (MD)
for Transition Tyvek® 1073B and Transition Tyvek® 1059B (ASTM D5034—in %) 45

38. Effects of sterilization and 1-year real-time aging on material elongation (CD)
for Transition Tyvek® 1073B and Transition Tyvek® 1059B (ASTM D5034—in %) 45

39. Effects of sterilization and 1-year real-time aging on puncture strength

for Transition Tyvek® 1073B and Transition Tyvek® 1059B (ASTM F1342—in lb f/4 in.) 46

40. Effects of sterilization and 1-year real-time aging on material microbial barrier
for Transition Tyvek® 1073B and Transition Tyvek® 1059B (ASTM F2638—in % pMax) 46

41. Barcode readability results for Transition Tyvek® 1073B 52

42. Pouch seal strength distribution for uncoated Transition Tyvek® 1073B
sealed to a 100-gauge bi-axial nylon with high-density polyethylene (HDPE) film (ASTM F88) 54

43. Microscopic view of Tyvek® (200x magnification) 54

44. Microscopic view of the smooth side of Tyvek® (25x magnification) 55

Contents 7
Contents
List of figures

45. Microscopic view of the rough side of Tyvek® (25x magnification) 55

46. Pictorial representation of Tyvek® during package opening 58

47. Pictorial representation of Tyvek® during opening at an extreme angle 58

48. Micrograph of folded Tyvek® showing sheet separation, a phenomenon

that does not compromise the integrity of the package 59

49. Channel in seal determined during dye penetration testing (ASTM F1929:2003) 59

50. Wicking occurs when dye is left too long in the pouch during ASTM F1929:2003 testing 59

51. Pouch folded over the edge of a rigid tray 60

52. Example of an unsealed area on a tray 61

53. Prediction of fiber tear based on lid alignment on tray 61

54. Multiple cavity thermoform with “skirt” seal or gap between sealed areas 62

55. DuPont sealing experiment to test the effect of lid placement on fiber tear 63

56. Results of improper lid placement during DuPont sealing experiment 63

This document is not intended for use in the People’s Republic of China.

Contents 8
 Why is Tyvek® the preferred
1
choice for sterile barrier systems?

Tyvek® for medical and pharmaceutical packaging Providing packaging science support
delivers trusted protection DuPont packaging engineers are available globally to
Since its introduction to the industry in 1972, DuPont™ support you with knowledge about materials, packaging
Tyvek® brand protective material has been recognized as design and processing to help optimize performance and
a standard of excellence for sterile medical packaging. total cost, as well as to ease implementation.
Tyvek® earned this distinction because it provides a high
Learn more about the science of protection
degree of microbial barrier in combination with excellent
with Tyvek®
porosity and puncture protection for sterile packaging of
medical devices and supplies. The unique flashspun structure of Tyvek® gives it inherent
advantages, including:
Helping speed up your compliance process
Outstanding resistance to microbial penetration
In this guide you will find extensive compliance data
established by our network of regulatory affairs and Microbial barrier test data consistently prove that Tyvek®
technical experts to help you develop, validate and holds out microbes and particles better than other
document the most appropriate solutions for your porous packaging materials—even under the most
applications with Tyvek®. This will help you to meet rigorous conditions. Aging studies have proven that
worldwide regulations and packaging standards, while Tyvek® can maintain its properties for at least seven to
accelerating your product regulatory submissions 10 years. In addition, a long-term shelf-life study proved
and certifications. conclusively that Tyvek® can maintain sterility for at
least five years if package integrity is not compromised.
A separate document, MPTP styles 1073B and 1059B
The photomicrographs shown in Figure 1 illustrate how
compliance to EN ISO 11607, describes the compliance of
bacteria are trapped on the filament surfaces of Tyvek®.
Transition Tyvek® 1073B and Transition Tyvek® 1059B with
the materials portion of the EN ISO 11607-1 standard. Significantly reduced risk of package failure

Another separate document, Tyvek compliance to ISO

® The tough, continuous filaments of Tyvek® help protect
11607-1:2006/Amd.1:2014, describes the compliance of package integrity from both product breakthrough inside
Legacy Tyvek® 1073B, Legacy Tyvek® 1059B and and rough handling outside. Tyvek® is so tough, it resists
Tyvek® 2FS™ with the materials portion of the punctures—even from the irregular or sharp edges of
ISO 11607-1 standard. many surgical devices. Compared to medical-grade papers,
Tyvek® has superior tear strength and puncture resistance.

Figure 1. Scanning electron micrographs (SEMs) of Tyvek®.

Microbes trapped on filament surfaces of Tyvek® (500x magnification) Cross-sectional view of Tyvek® (500x magnification)

The unique structure of Tyvek®, which creates a tortuous path with substantial lateral movement, results in superior
microbial barrier protection.

Section 1 Why is Tyvek® the preferred choice for sterile barrier systems? 9
 Why is Tyvek® the preferred choice
1
for sterile barrier systems?

What’s more, because it is breathable, Tyvek® minimizes an effective way to conserve resources and demonstrate
the formation of condensation due to temperature environmental stewardship. Tyvek® is produced under
extremes that can occur during transport. This verified environmental management policy according to
breathability also allows medical packages made with ISO 14001.
Tyvek® to equilibrate rapidly from the pressure changes
If the Tyvek® has not been in contact with any hazardous
that occur not only during shipping and in storage
substance, it can be recycled at local recycling facilities
environments, but also during sterilization. This helps
that accept HDPE waste according to local legislation.
alleviate stress on the seals.
DuPont and other leading companies in the healthcare,
Low risk of device contamination
recycling and waste management industries have come
The unique structure of Tyvek® generates very few together to form the Healthcare Plastics Recycling Council
airborne particles when packages are opened or handled. (HPRC). The technical coalition is working to inspire and
This clean peel minimizes the risk of introducing enable sustainable, cost-effective recycling solutions for
particulates into highly controlled environments such as plastic products and materials used in the delivery of
operating rooms, cleanrooms and aseptic filling processes, healthcare. For more information, visit the HPRC website.
helping to address increasingly stringent industry and
regulatory requirements.
Tyvek®—origins and how it is made
A miracle of science from DuPont
Biocompatibility, food contact and pharmacopeia
The discovery of Tyvek® was a chance occurrence by a
Tyvek® styles for medical and pharmaceutical packaging
DuPont researcher, Jim White, who in 1955 noticed white
applications are manufactured to rigorous quality
polyethylene fluff coming out of a pipe in a DuPont
standards to meet the unique requirements of these
experimental lab. After examining this material, it was
highly regulated industries. They meet all the acceptable
found that it had some very interesting properties. A
performance criteria for biocompatibility—even after
program to develop the new material was set up, and a
sterilization—when tested according to ISO 10993 and
year later DuPont submitted a patent proposal for strong
United States Pharmacopeia (USP). In addition, all styles
yarn linear polyethylene.
meet the extractable or composition requirements of
various food contact regulations, such as 21 CFR 177.1520 The proprietary flash-spinning technology, which is the
and Commission Regulation (EU) No. 10/2011; and all basis for what was to become a new engineered sheet
styles other than Tyvek® 2FS™ meet the requirements structure from DuPont, took several more years to perfect.
of pharmacopeia regulations such as European In 1959, a pilot facility was established for trial applications
Pharmacopeia, Section 3.1.5. For the applicable revision such as book covers, tags, labels and certain garments. In
dates of the different test standards, please refer to 1965, the new engineered sheet structure was registered
Section 3, “Biocompatibility, food contact, pharmacopeia under the trademark name Tyvek®, but it was not until April
and bioburden.” 1967 that commercial production of Tyvek® started. In 1972,
the first styles of Tyvek® designed for use in medical and
Compatibility with a broad range
pharmaceutical packaging applications were developed.
of sterilization modalities
Flash-spinning and bonding process
Only Tyvek® is compatible with the most commonly used
sterilization modalities: ethylene oxide (EO), gamma, Tyvek® is formed by a fully integrated process using
electron-beam, steam or dry heat (under controlled continuous and very fine filaments (having an average
conditions) or low-temperature oxidative sterilization diameter of 4 µ) of HDPE that are randomly distributed
processes. Results from testing of Tyvek® exposed to and multi-directional. (For purposes of comparison,
each of these modalities show it retained its protective a human hair is approximately 75 µ in cross section.)
properties of microbial barrier and strength, as well as its These filaments are first flashspun, then laid as a web
color and flexibility. on a moving belt before being bonded together.
By varying the flash-spinning and bonding process
Helps you meet your environmental goals
conditions, DuPont can engineer the sheet properties to
As for ecological responsibility, Tyvek® is an excellent meet specific market needs.
choice because it is made of virgin high-density
polyethylene (HDPE). This lightweight, durable material is

Section 1 Why is Tyvek® the preferred choice for sterile barrier systems? 10
 Why is Tyvek® the preferred choice
1
for sterile barrier systems?

Tyvek® for medical and pharmaceutical packaging and quality. We develop and participate in conferences
applications is neither corona treated nor anti-static to help the industry stay at the forefront of standards,
treated because these treatments may compromise the regulations and new technologies. In addition, members of
barrier characteristics of Tyvek®. The styles of Tyvek® our team regularly participate on activities within:
designed for use in medical and pharmaceutical packaging
• ASTM International
applications are: Tyvek® 1073B, Tyvek® 1059B and
Tyvek® 2FS™. These styles are manufactured to rigorous • International Organization for Standardization (ISO)
quality standards to address the unique requirements
• European Committee for Standardization (CEN)
for medical and pharmaceutical packaging applications,
according to good manufacturing practices (Commission • Association for the Advancement of Medical
Regulation [EU] No. 2023/2006). Instrumentation (AAMI)

Dual sourcing • Standardization Administration of the

People’s Republic of China (SAC)
Tyvek 1073B and Tyvek 1059B are manufactured in two
® ®

different locations—Richmond, VA in the United States • Japanese Standards Association (JSA)

and Contern, Luxembourg in Europe. This provides greater
• Sterile Barrier Association (SBA)
long-term continuity and flexibility of Tyvek® supply.
Tyvek® 2FS™ is produced in Luxembourg. • Parenteral Drug Association (PDA)
At the forefront of technological and • Healthcare Plastics Recycling Council (HPRC)
regulatory development
Contact our experts
An industry and technology leader
If you have questions or need additional support with
As leaders in the industry, we are dedicated to sharing submission challenges, troubleshooting, analytical
information and expertise on topics ranging from industry services, as well as packaging and regulatory compliance,
standards and regulatory compliance to technical issues contact your local DuPont representative.

Section 1 Why is Tyvek® the preferred choice for sterile barrier systems? 11
 Why is Tyvek® the preferred choice
1
for sterile barrier systems?

Sterile barrier systems (SBS) made of Tyvek® Figure 2. Pouches made with Tyvek®.

Packaging for terminally sterilized medical devices, also

defined as sterile barrier system (SBS) in ISO 11607, serves
different key functions. The first is to allow for sterilization.
The second is to maintain sterility and package integrity
throughout all steps of the value chain until the point
of use by providing an appropriate microbial barrier, as
well as physical protection against damage, while not
interacting with the packaged devices. At the healthcare
setting, medical professionals should be able to open the
Figure 3. Sterilization bag made with Tyvek®.
SBS smoothly while ensuring an aseptic presentation of
the packaged product. Identification of the product must
be printed on either the package or on a label.
The following porous SBS can be made with Tyvek® to
optimally serve all the functions previously described:
• Pouches (peelable): Top web Tyvek®; bottom web film
• Sterilization bags (non-peelable, therefore transparent
seals can be created): Top web Tyvek®; bottom web film
• Header bags/vented bags: Film or aluminum-based bag Figure 4. Header bag made with Tyvek®.
with Tyvek® window or vent
• Flexible or rigid trays—form-fill-seal (FFS): Top web
Tyvek®; bottom web film
• Rigid trays—preformed from film: Top web Tyvek®;
bottom web film
• Nested tubs: Top web Tyvek®; inner layer sheet Tyvek®;
bottom web film (the entire system is then packed in
one to three pouches or header bags)
Figure 5. Flexible and rigid trays made with Tyvek®.
• Others (four-side-seal pouches; gusseted pouches;
pouch reels; flow packs; etc.)

Figure 6. Nested tub made with Tyvek®.

Section 1 Why is Tyvek® the preferred choice for sterile barrier systems? 12
 Why is Tyvek® the preferred choice
1
for sterile barrier systems?

Tyvek® vs. medical-grade papers: heat and pressure during manufacture. The result is a
a comparison of properties tough, durable sheet structure that provides a unique
combination of physical properties that no other sterile
Tyvek® offers an optimum balance of microbial penetration
packaging material can match.
resistance, tear strength, puncture resistance and low
linting features (for clean peel and low particulate), Tyvek® has become a standard of excellence against which
as well as compatibility with the most commonly used other sterile packaging materials are judged. When tested
sterilization modalities, including: EO, gamma, electron- against other porous packaging materials, data from
beam, steam or dry heat (under controlled conditions) Tyvek® shows it consistently performs excellently in tests
and low-temperature oxidative sterilization processes. for microbial barrier; tear; puncture and burst strength;
resistance to breakage; liquid resistance; EO desorbance;
The secret to the superior performance of Tyvek® is that
and particle generation.
it is not made of cellulosic fibers, but rather a sheet
of flashspun and bonded HDPE filaments. Continuous Figure 7 provides an overview showing various physical
strands of very fine, interconnected filaments are properties of Tyvek® compared to medical-grade papers.
multi-directionally oriented and bonded together by

Figure 7. Tyvek® vs. medical-grade papers: a comparison of properties—microbial barrier (ASTM F2638), Mullen burst (ISO 2758),
Elmendorf tear (ASTM 1424 and EN 21974), elongation (EN ISO 1924-2) and hydrostatic head (AATCC TM 127 and EN 20811).

Microbal barrier, % pMax

ASTM F2638

Hydrostatic head, in. H2O Elmendorf tear (MD), lbf

AATCC TM 127 and EN 20811 ASTM D1424 and EN 21974
70
15
50 0.60

30 0.40

10 DuPont™ Transition
0.20
Tyvek® 1073B
21 0
(uncoated)

40 DuPont™ Transition
Tyvek® 1059B
10 (uncoated)

DuPont™Tyvek® 2FS™
120
(uncoated)
20
Upper Lower
Medical-grade papers
(coated & uncoated)
30 200

Elongation (MD), % Mullen burst, psi Synthetic

EN ISO 1924-2 ISO 2758 fiber-reinforced paper

Due to the smaller sampling populations used for these material comparisons, the Tyvek® data presented in this section
may differ slightly from the specification and miscellaneous properties tables.

Section 1 Why is Tyvek® the preferred choice for sterile barrier systems? 13
 Why is Tyvek® the preferred choice
1
for sterile barrier systems?

Excellent barrier to microbial penetration Tyvek® 2FS™ demonstrates that these Tyvek® medical and
The number-one priority in selecting packaging materials pharmaceutical packaging styles all have a pMax around ~
1% (for Tyvek® 1073B and Tyvek® 1059B) and ~2%
for medical devices is the ability of the package to
(for Tyvek® 2FS™). The pMax of the other tested porous
maintain sterility from the point of sterilization until the
sterile barrier materials ranges from approximately 4.0% to
product is opened for use. Even under the most rigorous
14.0%.
conditions in highly contaminated environments, Tyvek® is
highly resistant to penetration by bacterial spores and Tyvek® is exceptional at maintaining microbial barrier
other contaminating microorganisms. throughout product distribution. A study compared Legacy
Tyvek® 1073B and Tyvek® 2FS™ to four different medical-
Particulate and bacteriological tests clearly demonstrate
grade papers in standard chevron pouches. Microbial
that Tyvek® outperforms other commercially available
barrier testing was conducted according to ASTM F2638,
porous packaging materials, including medical-grade
before and after sterilization (EO, gamma) and subsequent
papers (Figure 8). Aging studies have proven that Tyvek®
transportation testing.
can maintain its properties for at least seven to 10 years. In
addition, a long-term shelf-life study proved conclusively The study showed that three of the four types of medical-
that Tyvek® can maintain sterility for at least five years grade paper showed a significant decrease in microbial
if package integrity is not compromised. See Section 5, barrier performance after gamma sterilization and after
“Stability testing” for details. environmental conditioning and transportation testing
compared to pre-sterilization. This decrease in microbial
ASTM F2638 Standard test method for using aerosol
barrier performance was mainly linked to creases and
filtration for measuring the performance of porous
punctures in the material. The same three medical-grade
packaging materials as a surrogate microbial barrier
measures the ability of a porous substrate to prevent paper types had the poorest microbial barrier performance
particle penetration. All materials have a face velocity overall, including pre-sterilization. Legacy Tyvek® 1073B and
where maximum percent particle penetration occurs Tyvek® 2FS™ showed the best barrier performance overall
(% pMax). The lower the percent penetration, the better compared to the four medical-grade paper types.
the performance. Details are contained in the white paper titled
ASTM F2638 testing of Tyvek 1073B, Tyvek 1059B and
® ® “Medical packaging study—The impact of sterilization and
transportation testing on the microbial barrier of different
materials.”% pMax with a particle size of 1 µm, face velocity max
Figure 8. Particle penetration of porous sterile barrier materials (ASTM F2638—in
25 cm/min or flow max 1.5 or 2 L/min).

15

13.4
12

3.8 - 10.5
9
% pMax

~ 1% ~ 1% ~ 2%
0
DuPont™ Transition DuPont™ Transition DuPont™ Tyvek® 2FS™ Medical-grade papers Synthetic
Tyvek® 1073B (uncoated) Tyvek® 1059B (uncoated) (uncoated) (coated & uncoated) fiber-reinforced paper

ASTM F2638, Standard test method for using aerosol filtration for measuring the performance of porous packaging materials as a
surrogate microbial barrier, measures the ability of a porous substrate to prevent particle penetration, which is highly correlated to
microbiological
DuPont™spore
Tyvekpenetration.
®
1073B All materials
DuPont ™
Tyvekhave
® a face velocity
1059B DuPontwhere
™ maximum
Tyvek®
2FS™ percent particle penetration
Medical-Grade Papers occursSynthetic
(% pMax). The
lower the percent penetration, the better(uncoated)
(uncoated) the performance. For more information, see “Microbial
(uncoated) (coatedbarrier properties of
& uncoated) porous sterile barrier
Fiber-Reinforced Paper
systems: does selection of packaging material matter?” in our Medical Packaging Knowledge Center.

Section 1 Why is Tyvek® the preferred choice for sterile barrier systems? 14
 Why is Tyvek® the preferred choice
1
for sterile barrier systems?

Superior tear strength, puncture resistance during rough handling. Compared to many commonly
and burst strength used medical-grade papers, Tyvek® provides superior
The tough, continuous filaments of Tyvek® protect your puncture resistance and tear strength, which means that
Tyvek® does not puncture easily and tears do not readily
package from product breakthrough (Figure 9) and also
from penetration by an object outside the packaging propagate if a package is nicked (Figure 10).

Figure 9. Mullen burst properties of Tyvek® styles and medical-grade papers (ISO 2758—in psi).
200

186
150

147
134
psi

100

50
59
43 - 60

0
DuPont™ Transition DuPont™ Transition DuPont™ Tyvek® 2FS™ Medical-grade papers Synthetic
Tyvek® 1073B (uncoated) Tyvek® 1059B (uncoated) (uncoated) (coated & uncoated) fiber-reinforced paper

This test measures the ability of a substrate to resist forces applied uniformly throughout the substrate. This property indicates how a material may perform
in environments
DuPontwhere
™
Tyvekpressure
™
1073Bchanges take place
DuPont ™ and
Tyvek ™ the package balloons ™
1059B DuPont orTyvek
where™ a2FS
force
™ is applied over a relatively large area, such as when a heavy
Medical-Grade Papers Synthetic
object is placed(uncoated)
on top of a lidded tray. (uncoated) (uncoated) ( coated & uncoated) Fiber-Reinforced Paper

Figure 10. Elmendorf tear (MD) properties of Tyvek® styles and medical-grade papers (ASTM D1424 and EN 21974—lb f).
MD = machine direction

0.6

0.58
0.5
0.52
0.49
0.4

0.3
lbƒ

0.2 0.25
0.09 - 0.18
0.1

0.0
DuPont™ Transition DuPont™ Transition DuPont™ Tyvek® 2FS™ Medical-grade papers Synthetic
Tyvek® 1073B (uncoated) Tyvek® 1059B (uncoated) (uncoated) (coated & uncoated) fiber-reinforced paper
This test measures the ability of a substrate to resist tearing when a highly localized force is applied. Elmendorf tear measures the force required to
propagate an initiated
DuPont ™ tear
Tyvek ® for a unit distance. The
1073B unit is® lb
DuPont™ Tyvek 1059B
f
. The higherDuPont
the value,
™ the less
Tyvek® 2FSlikely
™ a material will tear under
Medical-Grade force. This property
Papers is important
Synthetic
because nicks and cuts may occur at the edge of a lid and could affect its clean peel. The tear strength of Tyvek® is significantly higher than that of medical-
grade paper. (uncoated) (uncoated) (uncoated) (coated & uncoated) Fiber-Reinforced Paper

Section 1 Why is Tyvek® the preferred choice for sterile barrier systems? 15
 Why is Tyvek® the preferred choice
1
for sterile barrier systems?

Exceptional flexibility to prevent breakage “Medical packaging study—reducing the risk of failure
through performance testing of packaging made from
Tyvek® is an extremely flexible packaging material that
various materials.”
will not break or tear as easily as commonly used medical-
grade papers (Figure 11). This resiliency, combined with Outstanding moisture resistance and moisture
the inherent strength of Tyvek®, offers the opportunity for vapor transmission
form-fill-seal packaging lines to run smoothly and without
Tyvek® has outstanding moisture resistance, unlike
significant downtime due to material web breaks, and
medical-grade paper. In fact, water in contact with Tyvek®
helps packages resist damage during handling, distribution
does not wet its surface or spread; it simply remains
and storage.
as droplets on the surface. That’s because Tyvek® is
To demonstrate that Tyvek® can withstand very high hydrophobic and does not absorb moisture, giving it
environmental challenges, DuPont conducted an extensive distinct advantages compared to medical-grade paper
performance testing study to evaluate the performance (Figure 12).
of standard chevron pouches made with either Legacy
For example, when medical-grade paper absorbs moisture,
Tyvek® 1073B, Tyvek® 2FS™ or one of five different medical-
its strength and puncture resistance are reduced. This can
grade papers. Seal strength and package integrity
greatly influence package performance, especially during
were measured after sterilization (EO, gamma), after
distribution. In sharp contrast to medical-grade paper,
accelerated aging and after conditioning and subsequent
Tyvek® maintains its superior strength both wet and dry,
transportation testing.
and it does not swell.
The study showed that none of the pouches made with
In addition to its outstanding moisture resistance,
Legacy Tyvek® 1073B or Tyvek® 2FS™ showed loss of
another advantage of Tyvek® is that a high moisture
integrity after transportation testing. On the other hand,
vapor transmission rate (MVTR) can be achieved. This
loss of integrity was reported for three of the five types
is particularly important for the EO sterilization process
of medical-grade paper that were evaluated in this study.
where water is introduced as a vapor because moisture
The integrity failures, which were observed after gamma
enhances the effectiveness of EO as a sterilant. Likewise,
sterilization, were all linked to punctures and/or creases in
high MVTR is also essential for effective and productive
the paper.
steam sterilization processes.
Complete details about the scope of the study and the
materials tested can be found in the white paper titled

Figure 11. Elongation (MD) properties of Tyvek® styles and medical-grade papers (EN ISO 1924-2—in % with a modified speed, sample
width and gauge length). MD = machine direction

25

22.4 21.9
20

15
17.4
%

10

5
2.2 - 4.5
3.1
0
DuPont™ Transition DuPont™ Transition DuPont™ Tyvek® 2FS™ Medical-grade papers Synthetic
Tyvek® 1073B (uncoated) Tyvek® 1059B (uncoated) (uncoated) (coated & uncoated) fiber-reinforced paper

Elongation is the ™measure® of the extent a substrate will stretch before it breaks.™ The higher the value, the more a package will stretch before it breaks.
DuPont Tyvek 1073B DuPont™ Tyvek® 1059B DuPont Tyvek® 2FS™ Medical-Grade Papers Synthetic
(uncoated) (uncoated) (uncoated) (coated & uncoated) Fiber-Reinforced Paper

Section 1 Why is Tyvek® the preferred choice for sterile barrier systems? 16
 Why is Tyvek® the preferred choice
1
for sterile barrier systems?
Figure 12. Hydrostatic head properties of Tyvek® styles and medical-grade papers (AATCC TM 127 and EN 20811—in in. H2O with a rate
of use of 24 in. H2O/min). Hydrohead values may differ slightly after hydrogen peroxide gas plasma sterilization; for more details, see
Section 4. “Sterilization compatibility.”

80

70
69
60 65
61
50
in. H2O

40

30 22 - 36
31
20

10

0
DuPont™ Transition DuPont™ Transition DuPont™ Tyvek® 2FS™ Medical-grade papers Synthetic
Tyvek® 1073B (uncoated) Tyvek® 1059B (uncoated) (uncoated) (coated & uncoated) fiber-reinforced paper
Hydrostatic head is the measure of the pressure required to force three drops of water through a substrate. The higher the value, the more resistant the
package is to water penetration.
DuPont Tyvek 1073B
™ ™
DuPont Tyvek 1059B
™ ™
DuPont Tyvek 2FS
™ ™ ™
Medical-Grade Papers Synthetic
(uncoated) (uncoated) (uncoated) ( coated & uncoated) Fiber-Reinforced Paper

Section 1 Why is Tyvek® the preferred choice for sterile barrier systems? 17
 Why is Tyvek® the preferred choice
1
for sterile barrier systems?

Occasionally, medical device and pharmaceutical packages In addition, medical-grade papers may change color
are subjected to adverse conditions that allow them to when sterilized with gamma radiation; however, Tyvek®
get wet, such as rain on a loading dock or flooding. When will not (see Figure 28 in Section 4. “Sterilization
this occurs, the time of exposure and severity are not compatibility”). DuPont performed an extensive study to
typically known. Because most device manufacturers label evaluate the performance of standard chevron pouches
their packages as “sterile unless opened or damaged,” we made with either Legacy Tyvek® 1073B, Tyvek® 2FS™
believe water exposure under these types of scenarios or one of five different medical-grade papers. Tyvek®
would constitute damage. remained unchanged, while all five medical-grade paper
pouches showed some visible color change post gamma
Compatibility with a broad range
sterilization.
of sterilization modalities
Only Tyvek® is compatible with the most commonly To learn more, download the white paper titled
“Medical packaging study—reducing the risk of failure
used sterilization modalities. No matter which method
through performance testing of packaging made from
you use: EO, gamma, electron-beam, steam or dry heat
various materials.”
(under controlled conditions) or low-temperature oxidative
sterilization, Tyvek® will retain its protective properties Rapid EO desorption*
of microbial barrier and strength, as well as its color
EO does not readily adsorb on Tyvek® and is released
and flexibility. Low-temperature oxidative sterilization
more rapidly than from cellulosic materials such as
processes, such as hydrogen peroxide gas plasma,
medical-grade papers, including synthetic fiber-reinforced
cannot be used with cellulosic materials such as
paper (Figure 13).
medical-grade paper.

Figure 13. Ethylene oxide (EO) residual concentration in porous sterile barrier materials after sterilization and aeration for 6, 12, 24 and
48 hours. The residual analysis was conducted according to ISO 10993-7.

6 hours 12 hours 24 hours 48 hours

10

6
EO ppm

0
DuPont™ Legacy DuPont™ Legacy DuPont™ Legacy DuPont™ Legacy DuPont™ Tyvek® 2FS™ 55# coated 52# coated Synthetic
Tyvek® 1073B Tyvek® 1073B Tyvek® 1059B Tyvek® 1059B (uncoated) paper paper fiber-reinforced paper
(uncoated) (coated) (uncoated) (coated)

DuPont™ Tyvek® 1073B DuPont™ Tyvek® 1073B DuPont™ Tyvek® 1059B DuPont™ Tyvek® 1059B DuPont™ Tyvek® 2FS™ 55# coated 52# coated Synthetic
(uncoated) (coated) (uncoated) (coated) (uncoated)
*B ased on data generated on Legacy Tyvek®. Transition Tyvek® has been proven to be functionally equivalent. Legacy Tyvek®paper paper
is either Tyvek® 1073B Fiber-Reinforced Paper
or Tyvek® 1059B produced on
the original manufacturing lines. Transition Tyvek® is either Tyvek® 1073B or Tyvek® 1059B produced on the newer manufacturing lines.

Section 1 Why is Tyvek® the preferred choice for sterile barrier systems? 18
 Why is Tyvek® the preferred choice
1
for sterile barrier systems?

Low linting The material samples were subjected to a combined

twisting and compression action in a test chamber.
Unlike medical-grade paper, which can release a significant
During the flexing, air was withdrawn from the chamber
number of particulates when a package is opened, the
and the particles generated were enumerated and sized
unique continuous filament structure of Tyvek® results in Uncoated 60g Medica
using a laser particle counter. Both sides of each material
clean peel and low lint features that help minimize the
were tested and the average number of particles per sizeReinforced 83g Medic
risk of device contamination when packages are opened
was reported.
or handled. Therefore, Tyvek® is also an excellent choice
as a sterile packaging material for use in very sensitive DuPont™ Tyvek® 105
Data showed that the Tyvek® samples generated fewer
processing environments, such as aseptic filling operations particles than the medical-grade papers across the
DuPont™ Tyvek® 107
in pharmaceutical applications. entire size range, from 0.3 µm to 25.0 µm (Figure 14). The
Tests were conducted to measure the quantity and size medical-grade papers tested in this study generated up
of particles generated by Tyvek® and medical-grade to 180,000 particles while Tyvek® generated less than 50.
This study shows that Tyvek® generates significantly fewer
papers after twisting and compression of the material.
A standard test method for determining lint and other airborne particulates that could contaminate either the
particles generated in the dry state (Gelbo Flex) was used. medical device or the sterile field.
The method was designed to comply with the intent
of ISO 9073-10.

Figure 14. Particles generated by Transition Tyvek® 1073B, Transition Tyvek® 1059B and two commonly used medical-grade papers
(Gelbo Flex testing method, ISO 9073-10).

DuPont™ Transition DuPont™ Transition Reinforced >80-g medical-grade paper Uncoated 60-g medical-grade paper
Tyvek® 1073B Tyvek® 1059B

100k

82,658
80k

60k

43,129
39,305
40k

20k
Number of particles

14,777

2923
196
200

160

120

80
66
55
49
40

18 18
10 7 7 9 6
5 4 1 2 2 1 5
0
0

0.3 0.5 1.0 5.0 10.0 25.0

Particle size (µm)

Section 1 Why is Tyvek® the preferred choice for sterile barrier systems? 19
2 Tyvek®—properties

The unique structure of Tyvek®—tough, continuous It is important to note that these specification and
filaments—creates both a tortuous path for superior miscellaneous properties are for uncoated Tyvek® as sold
microbial barrier and excellent strength properties. by DuPont. Any downstream operations, such as coatings
applied by sterile packaging manufacturers (SPMs), may
Made of high-density polyethylene (HDPE), Tyvek® offers
change these values.
the best characteristics for packaging in one material. This
unique balance of properties, which cannot be found in A description of the test methods used for these
any other material, makes Tyvek® lightweight yet strong; specification and miscellaneous properties can be found
vapor-permeable and yet moisture-resistant; as well as in “Aligned test methods and sampling plans for Tyvek®
puncture-, tear- and abrasion-resistant. Tyvek® is also low- medical and pharmaceutical packaging styles.”
linting, smooth and opaque with a white surface that can
Specification vs. miscellaneous properties
be printed using standard commercial printing equipment.
Specification properties are based on roll averages, with
Specification and miscellaneous properties samples taken uniformly across the sheet. Specification
of Tyvek® properties are controlled to a nominal value and released
Specification properties of Tyvek® styles for medical and within release specifications. The values for miscellaneous
pharmaceutical packaging applications can be found at the properties are typical but carry no warranty, expressed
following links. or implied.
Specification properties of Transition Tyvek® 1073B For Transition Tyvek® 1073B, Transition Tyvek® 1059B and
and 1059B Tyvek® 2FS™, specification properties are basis weight,
Gurley Hill porosity and delamination.
Specification properties of Tyvek® 2FS™
Miscellaneous properties are the result of keeping the
Miscellaneous properties of Tyvek® styles for medical and
three specification properties on aim. Sampling plans
pharmaceutical packaging applications can be found at the
for both specification properties and for miscellaneous
following links.
properties are described in “Aligned test methods and
Miscellaneous properties of Transition Tyvek® 1073B sampling plans for Tyvek® medical and pharmaceutical
and 1059B packaging styles.”

Miscellaneous properties of Tyvek® 2FS™

Section 2 Tyvek®—properties 20
2 Tyvek®—properties

Differential scanning calorimetry (DSC) and Tyvek® is made of virgin high-density polyethylene
infrared spectrum “fingerprinting” via ATR-FTIR (HDPE) with its typical characteristics. DuPont generated
differential scanning calorimetry (DSC), as well as infrared
spectrum curves as a reference.

Figure 15. DSC curves for Transition Tyvek® 1073B and Transition Tyvek® 1059B. Individual DSC plots–offset for clarity.

Transition Tyvek® 1073B Transition Tyvek® 1059B

Sample 1 Sample 4 Sample 7 Sample 10
Sample 2 Sample 5 Sample 8 Sample 11
Sample 3 Sample 6 Sample 9 Sample 12
Heat flow (W/g)

40 60 80 100 120 140 160 180

(104) (140) (176) (212) (248) (284) (320) (356)
Temperature, ˚C (˚F)

Note: Slight differences in crystallinity are consistent with normal DSC sampling and lot-to-lot variability.

Figure 16. DSC curves for Tyvek® 2FS™.

Tyvek® 2FS™
3.7000 mg 2.6000 mg
3.5000 mg 1.9000 mg
3.3000 mg
Heat flow (W/g)

40 60 80 100 120 140 160 180 200

(104) (140) (176) (212) (248) (284) (320) (356) (392)
Temperature, ˚C (˚F)

Note: Slight differences in crystallinity are consistent with normal DSC sampling and lot-to-lot variability.

Section 2 Tyvek®—properties 21
2 Tyvek®—properties

Figure 17. IR curves for Transition Tyvek® 1073B and Transition Tyvek® 1059B (including all line/polymer combinations). Sheet samples
analyzed using attenuated total reflectance (ATR)–fourier transform infared spectroscopy (FTIR).

100

94
% transmittance

88

82

76

70
4000 3000 2000 1500 1000

Wavenumbers (cm-1)

Figure 18. IR curves for Tyvek® 2FS™. Sheet samples analyzed using attenuated total reflectance (ATR)–Fourier transform infrared
spectroscopy (FTIR).

100

90
% transmittance

80

70

60

50
4000 3000 2000 1500 1000

Wavenumbers (cm-1)

Section 2 DuPont™ Tyvek®—properties 22

2 Tyvek®—properties

Tyvek® temperature resistance After each cycle, each material was evaluated and %
shrinkage in area was calculated. After the last cycle,
To demonstrate the temperature stability of Tyvek®,
physical properties, such as tensile and puncture strength,
DuPont performed an extensive dimensional stability
as well as microbial barrier, were measured.
study on Transition Tyvek® 1073B and Transition Tyvek®
1059B. Each material passed through the following steps: This study showed that Transition Tyvek® 1073B and
Transition Tyvek® 1059B retain their toughness and
• steam (261°F, 30 minute exposure, 30 minute drying)
flexibility down to -112°F. When exposed to heat, Tyvek®
• freeze (-112°F, minimum 24 hours) melts at approximately 275°F. Under actual processing
conditions, the temperature can influence the handling of
• thaw (minimum 24 hours)
the web. The range of exposures should be controlled or
• freeze (-112°F, minimum 24 hours) validated. During roll processing, it is recommended that
the web temperature should not exceed 175°F and web
• thaw (minimum 24 hours)
tension should remain below 0.75 lb/in.

Figure 19. Dimensional study for Transition Tyvek® 1073B and Transition Tyvek® 1059B.

Transition Tyvek® 1073B Transition Tyvek® 1059B

3
% shrinkage

0
Post steam Post initial freeze Post initial thaw Post final freeze Post final thaw

Study time point

Section 2 Tyvek®—properties 23
2 Tyvek®—properties

Table I. Coefficient of friction (COF)–static/dynamic—Transition Tyvek® 1073B, Transition Tyvek® 1059B and Tyvek® 2FS™ against
316 stainless steel (ASTM D1894)

Transition Tyvek® 1073B Transition Tyvek® 1059B Tyvek® 2FS™

Static COF

Rough, MD 0.167 0.197 0.120

Rough, CD 0.207 0.191 0.115

Smooth, MD 0.197 0.212 0.149

Smooth, CD 0.203 0.185 0.167

Dynamic COF

Rough, MD 0.099 0.103 0.090

Rough, CD 0.101 0.101 0.086

Smooth, MD 0.106 0.103 0.093

Smooth, CD 0.103 0.104 0.097

MD = machine direction; CD = cross direction

Chemical resistance low-molecular weight materials can act like solvents at

elevated temperatures, absorbing into the filaments (or
Because Tyvek® is made of HDPE, it is relatively
polymer) and causing swelling and wrinkling.
chemically inert.
Polyurethane adhesives provide optimum adhesion,
We do not recommend Tyvek® coming into contact with
flexibility and water resistance for adhering Tyvek® to
liquid chemicals in medical packaging applications. The
itself and to a variety of substrates. Hot melt polyamide
chemical substances may permeate or may react with the
adhesives form good bonds to Tyvek® with a variety
material. Each such application will need to be validated.
of materials.
A number of adhesives can be used to glue Tyvek®, either
The first step in choosing an adhesive is to verify if any of
to itself or to other substrates. Water-based synthetic
the components may interact with Tyvek®. Consultation
adhesives, such as ethylene/vinyl acetate adhesives,
with the adhesive manufacturer is recommended.
and the acrylic pressure-sensitive adhesives work well
with Tyvek®. The synthetic adhesives that contain

Section 2 Tyvek®—properties 24
 Biocompatibility, food contact,
3
pharmacopeia and bioburden

Biological evaluation of Transition Tyvek® 1073B and Tyvek® after exposure to sterilization by ethylene oxide
Transition Tyvek® 1059B for medical and pharmaceutical (EO), gamma, electron-beam, low-temperature oxidative
packaging was performed using testing methodologies (STERRAD® 100S, vaporized hydrogen peroxide) and steam
according to ISO 10993 and United States Pharmacopeia sterilization processes and proved that Transition Tyvek®
(USP). Tyvek® styles have also been tested for U.S. Food 1073B and Transition Tyvek® 1059B meet the performance
Contact 21 CFR 177.1520 and European Food Contact EC criteria after sterilization (Table II).
No. 10/2011. Further testing has been performed according
Biological evaluation of Tyvek® 2FS™ was performed using
to U.S. Pharmacopeia USP <88> Class VI, USP <661> and
testing methodologies according to ISO 10993 and United
<661.1> and to European Pharmacopeia EP 3.1.5 and EP
States Pharmacopeia (USP) and meets the performance
3.1.3, as well as Bioburden, which has been determined per
criteria for these tests (Table III). Tyvek® 2FS™ does not meet
testing requirements of ISO 11737-1:2006/R2011. Transition
European Pharmacopeia requirements.
Tyvek® 1073B and Transition Tyvek® 1059B meet the
performance criteria. Additional information can be obtained by contacting your
local DuPont representative.
Some critical tests such as extractables and leachables
have also been performed on samples of Transition

Section 3 Biocompatibility, food contact, pharmacopeia and bioburden 25

 Biocompatibility, food contact,
3
pharmacopeia and bioburden
Table II. Biocompatibility, food contact, pharmacopeia and bioburden testing results for Transition Tyvek® 1073B and
Transition Tyvek® 1059B
Biocompatibility

PASS:
• Pre-sterilization
Cytotoxicity (ISO 10993-5:2009) • Post-sterilization and 5- and 10-year accelerated aging
(EO, 100 kGy gamma, 100 kGy electron-beam, STERRAD® 100S,
vaporized hydrogen peroxide, steam)

Cytotoxicity (USP <87>) PASS (pre-sterilization)

USP <88> class VI biological reactivity tests, in vivo PASS (pre-sterilization)
Skin irritation and sensitization (ISO 10993-10:2010) PASS (pre-sterilization)
Pre-sterilization:
• No major bands of interest (infrared spectroscopy)
• No quantifiable extractables above a concentration of 1.0 µg/mL detected by
ICP-MS; GC-MS; UPLC-MS
Extractables and leachables (ISO 10993-18:2005: infrared Post-sterilization (EO, 100 kGy gamma, 100 kGy electron-beam,
spectroscopy; ICP-MS; GC-MS; UPLC-MS) STERRAD 100S, vaporized hydrogen peroxide, steam):
• No major bands of interest (infrared spectroscopy)
• No quantifiable extractables above a concentration of 1.0 µg/mL detected by
ICP-MS; GC-MS; UPLC-MS
• UPLC-MS testing—see*

Endotoxins
Endotoxins (USP <85>) PASS (pre-sterilization)
Bioburden

Bioburden (ISO 11737-1:2006) <100 cfu/ft2**

U.S. food contact
PASS (pre-sterilization, EO, 100 kGy gamma, 100 kGy
21 CFR 177.1520
electron-beam, STERRAD® 100S, vaporized hydrogen peroxide, steam)
U.S. Pharmacopeia
PASS (pre-sterilization, EO, 100 kGy gamma, 100 kGy
USP <661>
electron-beam, STERRAD® 100S, vaporized hydrogen peroxide, steam)
USP <661.1> PASS (pre-sterilization)
European food contact
PASS (pre-sterilization, EO, 100 kGy gamma,
EU N° 10/2011 and EC N° 2023/2006
100 kGy electron-beam, steam)
European Pharmacopeia

EP 3.1.5 and EP 3.1.3 (8th edition of European Pharmacopeia) Meets the compositional and extractable requirements (pre-sterilization)

EP 3.1.5 (8th edition of European Pharmacopeia)

Selected testing:
PASS (EO, 100 kGy gamma, 100 kGy electron-beam,
(1) Identification A:
STERRAD® 100S, vaporized hydrogen peroxide, steam)
IR spectrometry
(2) Hexane solubility
Japanese food sanitation law
Specifications and standards for foods, food additives
PASS (pre-sterilization)
and other materials (notification No. 370 of MHLW III-D-2)
Note: Please reference the listed standards to obtain explanations for the definition of “PASS”.
*Under extraction conditions of 158°F (70°C) for 24 hours in purified water, a compound tentatively identified as an “oxygenated unsaturated hydrocarbon”
was found to exceed the 0.1 µg/mL concentration allowance by ~0.01-0.25 µg/mL.
**Determined per testing requirement of ISO 11737-1:2006/R2011. This indication is based on a limited number of tests.

Section 3 Biocompatibility, food contact, pharmacopeia and bioburden 26

 Biocompatibility, food contact,
3
pharmacopeia and bioburden

Table III. Biocompatibility, food contact, pharmacopeia and bioburden testing results for Tyvek® 2FS™

Biocompatibility

Cytotoxicity (ISO 10993-5:2009) PASS (pre-sterilization)

USP <88> class VI biological reactivity tests, in vivo PASS (pre-sterilization)

Skin irritation and sensitization (ISO 10993-10:2010) PASS (pre-sterilization)

Pre-sterilization:
Extractables and leachables (ISO 10993-18:2005: infrared • No major bands of interest (infrared spectroscopy)
spectroscopy; ICP-MS; GC-MS; UPLC-MS) • No quantifiable extractables above a concentration of
1.0 µg/mL detected by ICP-MS; GC-MS; UPLC-MS

Bioburden

Bioburden (ISO 11737-1:2006) <100 cfu/ft2*

U.S. food contact

21 CFR 177.1520 PASS (pre-sterilization)

European food contact

EU N° 10/2011 and EC N° 2023/2006 PASS (pre-sterilization)

Japanese food sanitation law

Specifications and standards for foods, food additives

PASS (pre-sterilization)
and other materials (notification No. 370 of MHLW III-D-2)
Note: Please reference the listed standards to obtain explanations for the definition of “PASS”.
* Determined per testing requirement of ISO 11737-1:2006/R2011. This indication is based on a limited number of tests.

Section 3 Biocompatibility, food contact, pharmacopeia and bioburden 27

4 Sterilization compatibility

Unlike medical-grade papers and films, Tyvek® offers is extremely stable when exposed to sterilant gases and
sterilization compatibility with the most commonly used high-energy sterilization processes. In addition, Tyvek® is
modalities for sterilizing medical devices. These include: specially engineered to enable sterilant gases and steam
ethylene oxide (EO), gamma, electron-beam, steam or dry to penetrate and escape quickly. For the sterilization
heat (under controlled conditions) and low-temperature modality you choose, Tyvek® can retain its superior
oxidative sterilization processes (e.g., STERRAD® or protective properties of microbial barrier and strength, as
vaporized hydrogen peroxide). That’s because Tyvek® is well as its color and flexibility.
made of 100% high-density polyethylene (HDPE), which

Table IV. Material compatibility with various sterilization modalities

DuPont™ Tyvek® Medical-grade paper All film package

Ethylene oxide (EO) Yes Yes No

Gamma radiation Yes Yes1 Yes1,2

Electron-beam radiation Yes Yes Yes

Steam Yes3 Yes3 No

Dry heat Yes4 Yes No

STERRAD® Yes No No

Vaporized hydrogen peroxide Yes No No

1. May become brittle.

2. May entrap undesirable odors inside the package.
3. Under controlled conditions (250°F at 30 psi for 30 minutes with temperatures up to 260°F).
4. Under controlled conditions (250°F); cycle time to be validated.

Ethylene oxide (EO) transmission rate (MVTR) can be achieved (essential for
the effectiveness of EO as a sterilant) and that it allows
EO does not readily adsorb on Tyvek® and is released
medical packages to equilibrate rapidly from the pressure
more rapidly than from cellulosic materials such as
changes that occur during EO sterilization.
medical-grade papers, including synthetic fiber-reinforced
paper (see Figure 13 in Section 1, “Why is Tyvek® the See Table V and Figures 21-28 for details and data on
preferred choice for sterile barrier systems?). The sterilization compatibility of Tyvek®. Refer to Section 5,
superior strength and microbial barrier of Tyvek® are “Stability testing,” for test results after EO sterilization,
maintained after EO sterilization. Another advantage of accelerated and real-time aging.
the porous nature of Tyvek® is that a high moisture vapor

Table V. Ethylene oxide (EO) sterilization details for Tyvek® sterilization compatibility testing

Sterilization type Dosage Details

Ethylene oxide (EO) 2X cycles Total time per cycle (excluding pre- and post-conditioning): 8 hours and 10 minutes
EO exposure time per cycle: 8 hours and 0 minutes
EO concentration: 725 ppm
Maximum temperature: 131°F (55°C)
Maximum relative humidity: 60%
Maximum pressure rate change: 25 psi/min

Section 4 Sterilization compatibility 28

4 Sterilization compatibility

Radiation during transport. The breathability also allows medical

packages made with Tyvek® to equilibrate rapidly from the
Tyvek® maintains excellent microbial barrier properties
pressure changes that can occur in shipping and in storage
and experiences usually only slight changes in tensile
environments. This helps alleviate stress on the seals.
strength, elongation, microbial barrier and color when
exposed to radiation doses typically used in the medical Gamma and electron-beam
device industry. Unlike several other materials, Tyvek® After exposure to gamma or electron-beam radiation up
resists post-sterilization brittleness and when packages are to 100 kGy, Tyvek® maintains its superior microbial barrier
opened, Tyvek® maintains its low-linting performance. and the impact on strength properties is limited. See
Because Tyvek® is porous, undesirable odors produced by Tables VI and VII and Figures 21-28 for details and data on
radiation sterilization can be aerated out of the package. sterilization compatibility of Tyvek®.
Nonporous materials can trap these odors inside These properties are also maintained after irradiation
the packaging. followed by exposure to accelerated and real-time aging.
Furthermore, Tyvek® minimizes the formation of Refer to Section 5, “Stability testing” for test results
condensation due to temperature extremes that can occur after aging.

Table VI. Gamma radiation sterilization details for Tyvek® sterilization compatibility testing

Sterilization type Dosage Details

Gamma @25 kGy 1X cycle @25 kGy

@50 kGy 1X cycle @50 kGy
@100 kGy 1X cycle @100 kGy

Table VII. Electron-beam sterilization details for Tyvek® sterilization compatibility testing

Sterilization type Dosage Details

Electron-beam @25 kGy 1X cycle @25 kGy

@50 kGy 2X cycles @25 kGy
@100 kGy 4X cycles @25 kGy

Section 4 Sterilization compatibility 29

4 Sterilization compatibility

Steam conditions (250°F at 30 psi for 30 minutes with

temperatures up to 260°F).
Tyvek® has been shown to meet packaging criteria for
steam sterilization under controlled conditions (250°F Tensile strength, elongation, puncture resistance, microbial
at 30 psi for 30 minutes with temperatures up to 260°F). barrier and Gurley Hill porosity of Tyvek® are maintained
An advantage of the porous nature of Tyvek® is that a after steam sterilization under controlled conditions for
high MVTR can be achieved. Packaging using Tyvek® 30 minutes at temperatures up to 260°F. See Table VIII
for steam sterilization is commercial at medical device and Figures 21-28 for details and data on sterilization
and pharmaceutical manufacturers. Another advantage compatibility of Tyvek®.
of Tyvek® 1073B and Tyvek® 1059B is that they meet the
Rigid or semi-rigid trays restrict potential shrinkage and
requirements of European Pharmacopeia, Section 3.1.5.
wrinkling, which can result in a smoother/tighter lid.
Tyvek® continues to provide superior performance Shrinkage of Transition Tyvek® after steam sterilization
compared to medical-grade paper when strong, is less than 4% and Gurley Hill porosity is maintained
low-linting packaging is required. Tyvek® retains (Figure 20).
its dimensional stability and integrity—with no
Refer to Section 5, “Stability testing,” for test results
discoloration—when steam sterilized under controlled
after aging.

Table VIII. Steam sterilization details for Tyvek® sterilization compatibility testing

Sterilization type Dosage Details

Steam 1X cycle Total time per cycle: 1 hour and 0 minutes

Steam exposure per cycle: 0 hours and 30 minutes
Maximum temperature: 261°F (127°C)
Maximum pressure: 40 psia

Figure 20. Results of shrinkage tests and Gurley Hill porosity measurements conducted on Transition Tyvek® 1073B and
Transition Tyvek® 1059B after steam sterilization.

Transition Tyvek® 1073B Transition Tyvek® 1059B

Recommended temperature range
50

45

40

Pre-sterile
upper spec 35
Gurley Hill porosity (sec/100 cc )

30 Gurley Hill porosity 30

25 25
% shrinkage in area

20 20

15 15

10 10
Pre-sterile
lower spec
5 Shrinkage in area 5

0 0
250 253 257 261 264 268
(121) (123) (125) (127) (129) (131)
Temperature, ˚F (˚C)

Section 4 Sterilization compatibility 30

4 Sterilization compatibility

Low-temperature oxidative STERRAD® or vaporized hydrogen peroxide sterilization.

(STERRAD®, vaporized hydrogen peroxide) See Table IX and Figures 21-28 for details and data on
sterilization compatibility of Tyvek®. Refer to Section 5,
Transition Tyvek® 1073B and Transition Tyvek® 1059B
“Stability testing,” for test results after aging.
maintain superior strength and microbial barrier after

Table IX. Low-temperature oxidative sterilization details for Tyvek® sterilization compatibility testing

Sterilization type Dosage Details

Low-temperature oxidative: 1X cycle Total time per cycle: 0 hours and 55 minutes
STERRAD® 100S H2O2 exposure time per cycle: 0 hours and 28 minutes
Sterilant concentration: 58%
Maximum temperature: 131°F (55°C)

Low-temperature oxidative: 1X cycle Total time per cycle: 1 hour and 40 minutes
vaporized hydrogen peroxide H2O2 exposure time per cycle: 0 hours and 40 minutes
Sterilant concentration: 35%
Maximum temperature: 122°F (50°C)

Based on test data and extensive long-term use, it is Low-temperature oxidative sterilization processes should
clear that Tyvek® is well-suited for use with the STERRAD® not be used with cellulosic materials such as medical-
Sterilization System from Advanced Sterilization Products grade paper because these materials rapidly interact
(ASP), Division of Ethicon Inc., a Johnson & Johnson with the oxidizing agent and its superoxide radicals. This
company. This sterilization modality uses low-temperature can result in an aborted cycle due to inadequate sterilant
hydrogen peroxide gas plasma to enable sterilization of concentration. Tyvek® is made of HDPE and allows for an
heat-labile devices. effective sterilant concentration to be achieved.

Section 4 Sterilization compatibility 31

4 Sterilization compatibility

Although Tyvek® interacts only slightly with these types of Sterilization pouches and rolls intended for the
sterilants, the surface energy may be increased with some healthcare sterilization market
methods such as STERRAD®. This can cause a lowering of
Advanced Sterilization Products (ASP), Division of Ethicon
the hydrostatic head (Table X). The performance of Tyvek®
Inc., a Johnson & Johnson company, has developed a
as a sterile barrier is not affected (Figure 26) but the liquid
complete range of self-seal pouches, heat-seal pouches
test methods for assessing package integrity (such as dye
and heat-seal rolls made with Tyvek® for use in the
penetration and water immersion) can produce results that
STERRAD® System.
are different from untreated material. The data in Table X
demonstrates that the hydrostatic head is not affected by ASP also prints a STERRAD® Chemical Indicator on
vaporized hydrogen peroxide sterilization. its pouches and rolls to simplify the identification of
processed packages. The STERRAD® Sterilization process is
also used for industrial device sterilization with common
package configurations using Tyvek® protective material.
For information about the STERRAD® System, including
cycle time and performance details, visit the ASP website.

Table X. Effect of low-temperature oxidative sterilization on hydrostatic head and surface energy—Transition Tyvek® 1073B and
Transition Tyvek® 1059B

Property Comparable test method(s) Units Transition Tyvek® 1073B Transition Tyvek® 1059B

AATCC TM 127
Hydrostatic head in. H2O
EN 20811*

• pre-sterilization 63 62

• after STERRAD 100S sterilization

®
33 27

• after vaporized hydrogen peroxide sterilization 65 64

Surface energy–contact angle, rough side ASTM D5946 degrees

• pre-sterilization 97 96

• after STERRAD® 100S sterilization 68 62

• after vaporized hydrogen peroxide sterilization 96 93

Surface energy–contact angle, smooth side ASTM D5946 degrees

• pre-sterilization 94 93

• after STERRAD® 100S sterilization 61 59

• after vaporized hydrogen peroxide sterilization 94 91

*Rate of use: 60 cm H2O/min.

Section 4 Sterilization compatibility 32

4 Sterilization compatibility

Re-sterilization
It is important to note that although Tyvek® may
withstand re-sterilization with either gamma or electron-
beam, the device itself may not. If re-sterilization is
required, gas sterilization can also be performed. Tyvek®
will remain flexible after re-sterilization and will continue
to provide an excellent microbial barrier. Customers
must conduct their own tests to ensure suitability for the
intended application.
Tyvek® sterilization
compatibility—test results

Figure 21. Effects of sterilization on material tensile strength (MD) for Transition Tyvek® 1073B, Transition Tyvek® 1059B and
Tyvek® 2FS™ (ASTM D5034—in lb f/4 in.). MD = machine direction

Transition Tyvek® 1073B Transition Tyvek® 1059B Tyvek® 2FS™

120

100

80
lbf/4 in.

60

40

20

Pre-sterilization Ethylene Gamma* Gamma Gamma Electron beam* Electron beam Electron beam Steam* STERRAD® 100S* Vaporized
oxide (EO) @ 25 kGy @ 50 kGy @ 100 kGy @ 25 kGy @ 50 kGy @ 100 kGy @ 261°F (127°C) hydrogen peroxide*

Sterilization modality

*No results available for Tyvek ® 2FS ™.

Section 4 Sterilization compatibility 33

4 Sterilization compatibility

Figure 22. Effects of sterilization on material tensile strength (CD) for Transition Tyvek® 1073B, Transition Tyvek® 1059B and
Tyvek® 2FS™ (ASTM D5034—in lb f/4 in.). CD = cross direction

Transition Tyvek® 1073B Transition Tyvek® 1059B Tyvek® 2FS™

150

120

90
lbf/4 in.

60

30

Pre-sterilization Ethylene Gamma* Gamma Gamma Electron beam* Electron beam Electron beam Steam* STERRAD® 100S* Vaporized
oxide (EO) @ 25 kGy @ 50 kGy @ 100 kGy @ 25 kGy @ 50 kGy @ 100 kGy @ 261°F (127°C) hydrogen peroxide*

Sterilization modality

*No results available for Tyvek ® 2FS ™.

Figure 23. Effects of sterilization on material elongation (MD) for Transition Tyvek® 1073B, Transition Tyvek® 1059B and
Tyvek® 2FS™ (ASTM D5034—in %). MD = machine direction

Transition Tyvek® 1073B Transition Tyvek® 1059B Tyvek® 2FS™

25

20

15
%

10

Pre-sterilization Ethylene Gamma* Gamma Gamma Electron beam* Electron beam Electron beam Steam* STERRAD® 100S* Vaporized
oxide (EO) @ 25 kGy @ 50 kGy @ 100 kGy @ 25 kGy @ 50 kGy @ 100 kGy @ 261°F (127°C) hydrogen peroxide*

Sterilization modality

*No results available for Tyvek ® 2FS ™.

Section 4 Sterilization compatibility 34

4 Sterilization compatibility

Figure 24. Effects of sterilization on material elongation (CD) for Transition Tyvek® 1073B, Transition Tyvek® 1059B and Tyvek® 2FS™
(ASTM D5034—in %). CD = cross direction

Transition Tyvek® 1073B Transition Tyvek® 1059B Tyvek® 2FS™

30

25

20

15
%

10

Pre-sterilization Ethylene Gamma* Gamma Gamma Electron beam* Electron beam Electron beam Steam* STERRAD® 100S* Vaporized
oxide (EO) @ 25 kGy @ 50 kGy @ 100 kGy @ 25 kGy @ 50 kGy @ 100 kGy @ 261°F (127°C) hydrogen peroxide*

Sterilization modality

*No results available for Tyvek ® 2FS ™.

Figure 25. Effects of sterilization on material puncture strength for Transition Tyvek® 1073B, Transition Tyvek® 1059B and Tyvek® 2FS™
(ASTM F1342—in lb f).

Transition Tyvek® 1073B Transition Tyvek® 1059B Tyvek® 2FS™

3.5

3.0

2.5

2.0
lbf

1.5

1.0

0.5

0.0
Pre-sterilization Ethylene Gamma* Gamma Gamma Electron beam* Electron beam Electron beam Steam* STERRAD® 100S* Vaporized
oxide (EO) @ 25 kGy @ 50 kGy @ 100 kGy @ 25 kGy @ 50 kGy @ 100 kGy @ 261°F (127°C) hydrogen peroxide*

Sterilization modality

*No results available for Tyvek ® 2FS ™.

Section 4 Sterilization compatibility 35

4 Sterilization compatibility

Figure 26. Effects of sterilization on material microbial barrier for Transition Tyvek® 1073B, Transition Tyvek® 1059B and
Tyvek® 2FS™ (ASTM F2638—in % pMax with a particle size of 1 µm, flow max 2 L/min).

The lower the % pMax, the better the performance. Transition Tyvek® 1073B Transition Tyvek® 1059B Tyvek® 2FS™

3.5

3.0

2.5

2.0
% pMax

1.5

1.0

0.5

0.0
Pre-sterilization Ethylene Gamma* Gamma Gamma Electron beam* Electron beam Electron beam Steam* STERRAD® 100S* Vaporized
oxide (EO) @ 25 kGy @ 50 kGy @ 100 kGy @ 25 kGy @ 50 kGy @ 100 kGy @ 261°F (127°C) hydrogen peroxide*

Sterilization modality
*No results available for Tyvek ® 2FS ™.

ASTM F2638, Standard test method for using aerosol filtration for measuring the performance of porous packaging materials as a surrogate microbial barrier,
measures the ability of a porous substrate to prevent particle penetration, which is highly correlated to microbiological spore penetration. All materials
have a face velocity where maximum percent particle penetration occurs (% pMax). The lower the percent penetration, the better the performance. Please note
that the scale of the Y axis has been magnified (compared to Figure 8) to show detail. The data reported in this graph is the outcome of a study designed to
evaluate the compatibility of Tyvek® with various sterilization modalities and the effect on microbial barrier properties after exposure. The data is based on a
limited number of samples and does not include long-term variability. It is important to note that all Tyvek® styles have a low pMax in all conditions tested.

Figure 27. Effects of sterilization on material microbial barrier for Transition Tyvek® 1073B and Transition Tyvek® 1059B
(ASTM F1608—in LRV).
The higher the LRV, the better the performance. Transition Tyvek® 1073B Transition Tyvek® 1059B

4
Log reduction value (LRV)

0
Pre-sterilization Ethylene Gamma Steam Low-temperature
oxide (EO) @ 261°F (127°C) oxidative
Sterilization modality

ASTM F1608, Standard test method for microbial ranking of porous packaging materials (exposure chamber method), measures the ability of porous sterile
barrier materials to prevent bacterial spore penetration. A completely impermeable control sample (microbial penetration is zero) is challenged with one
million or 106 colony forming units (cfu). The number of cfu 106 has a log10 value of 6. If a sample challenged in the same way as the control allows 10 cfu (log
10=1) to penetrate, then its log reduction value (LRV) is 5 (6–1=5). Therefore, the higher the LRV, the more resistant the packaging is to microorganisms.

Section 4 Sterilization compatibility 36

4 Sterilization compatibility

Figure 28. Effects of sterilization on material color (L,a,b) for Transition Tyvek® 1073B and Transition Tyvek® 1059B.

A ∆Eab value of ~2.3 corresponds to Transition Tyvek® 1073B Transition Tyvek® 1059B
“a just noticeable difference.”

2.0

1.5
∆Eab (Average values*)

1.0

0.5

0.0
Ethylene oxide (EO) Gamma @ 100 kGy Electron beam @ 100 kGy Steam @ 261°F (127°C) STERRAD® 100S Vaporized hydrogen peroxide

Sterilization modality
*These values were obtained using a handheld X-Rite ® 500 Series Spectrodensitometer, with a white copier-grade backdrop and the following instrument settings: an observer angle
of 2° and illuminant type = D65 (representative of 6500 K daylight).
∆Eab = (L2 - L1)2 + (a 2 - a1)2 + (b2 - b1)2 where 2 = Pre-sterilization and 1 = Post-sterilization

Section 4 Sterilization compatibility 37

5 Stability testing

Performance of Tyvek® after aging sterility for at least five years, providing package integrity
is maintained. Newly generated accelerated and/or
Tyvek inherently resists penetration by microorganisms
®
real-time aging studies show that Tyvek® 1073B and
better than any other porous medical packaging material
Tyvek® 1059B can maintain physical and microbial barrier
because of its unique structure. Tyvek® is a sheet
properties for at least seven to 10 years and Tyvek® 2FS™
structure formed from continuous strands of very fine,
for at least five years.
interconnected filaments of high-density
polyethylene (HDPE). Please note: The data shown in Tables XI through XIII
are for uncoated samples of Tyvek®. It is important to
These filaments are multi-directionally oriented and
note that any downstream operations, such as coatings
bonded together by heat and pressure. This structure also
applied by sterile packaging manufacturers (SPMs), may
imparts other important properties for medical packaging,
affect the properties. Some of the data in this Section has
including: strength; resistance to penetration by water; low
been generated with Legacy Tyvek® and some data has
linting; puncture resistance; and air permeability.
been generated with Transition Tyvek®. Transition Tyvek®
Tyvek® can provide long-term sterility maintenance of has been proven to be functionally equivalent to Legacy
sterilized and packaged medical devices. The effectiveness Tyvek®. Legacy Tyvek® is either Tyvek® 1073B or Tyvek®
of Tyvek® in keeping medical devices sterile during storage 1059B produced on the original manufacturing lines.
has been conclusively demonstrated both by aging studies Transition Tyvek® is either Tyvek® 1073B or Tyvek® 1059B
and by all of the medical devices in the market with five- produced on the newer manufacturing lines. Additional
year—or longer—expiry dates. real-time aging study results will be added to this
Technical reference guide as they become available.
Test methods used to evaluate the microbial barrier
properties of Tyvek® include ASTM F2638, ASTM F1608 Summary of the 5-year shelf-life test protocol
and the DuPont Bacterial Test Chamber. Results from both
1. Contents of packages tested for initial sterility
material-based and whole-package shelf-life studies show:
Open petri dishes were sealed in special packages, 4.25
• Tyvek® holds out bacterial spores, even under the most in. x 6.75 in. (10.8 cm x 17.1 cm), designed to simulate
rigorous conditions. actual disposable medical devices sealed in packages. The
• The outstanding efficacy of Tyvek® as a bacterial barrier, package and contents were then sterilized using ethylene
even after repeated challenges. oxide (EO). Each package consisted of a lid of Tyvek® sealed
to poly-PET film.
• Tyvek® maintains sterility even after at least five
years of exposure to environments contaminated To ensure that the petri dish was sterile prior to long-term
with microorganisms. shelf storage, samples were randomly tested following
the United States Pharmacopeia (USP) methods for both
The first DuPont shelf-life studies of Tyvek® were initiated anaerobic and aerobic bacteria. An anaerobic chamber
in 1972 and demonstrated that Tyvek® resisted spore was used to test for anaerobic microbial contamination.
penetration for at least one year under normal conditions. The petri dish was removed from the opened package and
To extend that investigation, DuPont initiated a long- placed in a sterile bag containing either fluid thioglycolate
term shelf-life study of Tyvek® 1073B and Tyvek® 1059B culture medium or soybean casein digest broth. This tested
in 1978. The study was conducted at the DuPont Haskell the sterility of the packaged “device” before the multi-year
Laboratory for Toxicology. The objective of this program shelf-life study was started.
was to see how well these styles of Tyvek® would resist 2. Stored packages heavily dosed with bacterial spores
penetration by airborne bacterial spores. This test was
designed to have a more severe microbial challenge Packages containing sterile petri dishes were stored on
than typical real-world conditions. The samples were shelves in cabinets protected from outside contamination
challenged repeatedly with high bio-contamination levels and stored under controlled temperature and relative
(at ambient temperature and pressure) for months and humidity. Every four months throughout the entire five
years at a time. years of testing, each package was sprayed with a uniform,
massive dose of Bacillus circulans spores. Actual counts
The results of this study showed that Tyvek® is a indicated 4,000 to 5,000 spores on each package.
remarkably reliable microbial barrier. Tyvek® can maintain

Section 5 Stability testing 38

5 Stability testing

3. Package sterility checked periodically swatches were examined under a microscope and colonies
of B. circulans were counted. This acted as a check for the
To check sterility, 10 packages were withdrawn randomly
number of viable spores that were actually on the surface
from the storage shelves every six months and the outside
of Tyvek®. It also concluded that the density of spores was
surface of the poly-Mylar ® was disinfected. A small hole
consistently maintained over the many years of the test.
was then made through the poly-Mylar ® film and the petri
dish with a hot, pencil-tip soldering iron. Then, 15 mL Results of 5-year real-time aging study after
of sterile nutrient agar were injected into the petri dish EO sterilization
and the entry hole was covered with biocidal tape. If any
Tyvek® retains its physical properties over time, allowing a
spores had penetrated the lid of Tyvek®, they would have
package to maintain integrity.
grown on the culture medium after incubation. No spores
were detected on any samples during the study. Table XI shows the physical properties before and after
4. Tyvek is inspected for possible bacteria growth
® 5-year real-time aging of Legacy Tyvek® 1073B and Legacy
Tyvek® 1059B sterilized by EO. Tyvek® 1073B is the reference
The final part of the test procedure determined that the product providing the highest level of protection for all
packages were indeed challenged with the bacterial demanding applications and Tyvek® 1059B is the product
spores on the outside of the lid of Tyvek®. A small swatch providing robust protection for medium-risk applications.
of Tyvek® from the package lid was cut out and placed on
an agar medium. After evidence of bacteria growth, the

Table XI. Physical properties of Legacy Tyvek® sterilized by ethylene oxide (EO) before and after 5-year real-time aging*
Legacy Tyvek® 1073B Legacy Tyvek® 1059B
Property Test method Units Initial After 5 years Initial After 5 years
lbƒ/in. 0.47 0.44 0.45 0.49
Delamination ASTM D2724
(N/2.54 cm) (2) (2) (2) (2)
TAPPI T460 sec/100 cc
Gurley Hill porosity 37 37 30 28
ISO 5636-5
Log reduction
Microbial barrier Internal DuPont 5.21 unchanged 4.71 unchanged
value (LRV)
AATCC TM 127 in. H2O 59+ 59+ 59+ 59+
Hydrostatic head
EN 208112 (cm H2O) (150+) (150+) (150+) (150+)

ASTM D50353 lbƒ/in. 44.0 45.1 36.7 35.9

Tensile strength, MD
EN ISO 1924-23 (N/2.54 cm) (196) (201) (163) (160)

lbƒ/in. 1.53 1.57 1.33 1.44

Seal strength ASTM F884
(N/2.54 cm) (7) (7) (6) (6)
*B ased on data generated on Legacy Tyvek®. Transition Tyvek® has been proven to be functionally equivalent. Legacy Tyvek® is either Tyvek® 1073B or Tyvek® 1059B produced on
the original manufacturing lines. Transition Tyvek® is either Tyvek® 1073B or Tyvek® 1059B produced on the newer manufacturing lines.
MD= machine direction

1. Typical values. ASTM F1608 Standard did not exist so barrier was tested by internal DuPont method similar to the current Standard. Property remained unchanged after five years.
2. Rate of use: 60 cm H2O/min.
3. Modified for speed and gauge length.
4. Sealing conditions: temperature—290°F (143°C); dwell time—1 second; pressure (seal through the film)—90 psi (621 kPa).

Results of 1- and 7-year real-time aging study strength and microbial barrier were tested before and
after gamma and electron beam after aging. Original properties prior to sterilization are
shown to demonstrate the radiation stability of Legacy
Samples of Legacy Tyvek® 1073B and Legacy Tyvek® 1059B
Tyvek® (Table XII). Other polymeric materials that are not
were sterilized using gamma and electron beam and then
radiation stable are subject to chain scission reactions,
aged at room temperature for seven years. Both tensile
which greatly reduce physical properties.

Section 5 Stability testing 39

5 Stability testing

Table XII. Real-time aging test results for Legacy Tyvek® 1073B and Legacy Tyvek® 1059B*

Tensile strength1, MD Tensile strength¹, CD

Microbial
lbƒ N lbƒ N
barrier, LRV2

Gamma radiation 50 kGy**

Legacy Tyvek® 1073B

Pre-sterilization 42 187 48 213 5.23
Post-sterilization 33 147 39 175 —
After 7 years 32 142 33 148 5.2
Legacy Tyvek® 1059B
Pre-sterilization 37 163 40 178 4.73
Post-sterilization 28 122 31 138 —
After 7 years 27 118 29 127 4.1

Gamma radiation 100 kGy**

Legacy Tyvek® 1073B

Pre-sterilization 42 187 48 213 5.23
After 7 years 23 103 29 130 5.1
Legacy Tyvek® 1059B
Pre-sterilization 37 163 40 178 4.73
After 7 years 19 85 22 99 4.2

Electron-beam radiation 50 kGy**

Legacy Tyvek® 1073B

Pre-sterilization 42 187 48 213 5.23
Post-sterilization 37 164 35 157 —
After 7 years 36 159 33 145 5.2
Legacy Tyvek® 1059B
Pre-sterilization 37 163 40 178 4.73
Post-sterilization 32 143 33 145 —
After 7 years 30 135 28 124 4.9

Electron-beam radiation 100 kGy**

Legacy Tyvek® 1073B

Pre-sterilization 42 187 48 213 5.23
Post-sterilization 27 120 27 120 —
After 7 years 22 96 25 113 5.2
Legacy Tyvek® 1059B
Pre-sterilization 37 163 40 178 4.73
Post-sterilization 24 106 27 121 —
After 7 years 21 94 21 93 4.3
*B ased on data generated on Legacy Tyvek®. Transition Tyvek® has been proven to be functionally equivalent. Legacy Tyvek® is either Tyvek® 1073B or Tyvek® 1059B produced on
the original manufacturing lines. Transition Tyvek® is either Tyvek® 1073B or Tyvek® 1059B produced on the newer manufacturing lines.
**50 kGy was a single dose; 100 kGy was a cumulative amount, representing a double dose of 50 kGy.

1. ASTM D5035 and EN ISO 1924-2; modified for speed, sample width (1 in. [2.54 cm]) and gauge length.
2. L
 og reduction value (LRV) as tested per ASTM F1608. Note that ASTM F1608 Standard did not exist when the test was initiated, so barrier for the original value was tested by an
internal DuPont method similar to the current Standard.
3. Typical values. ASTM F1608 was not available in 1990 when the test was initiated.

Section 5 Stability testing 40

5 Stability testing

Results of 1-, 3-, 5-, 7- and 10-year conditions of 122°F and 23% relative humidity (RH),
accelerated aging study after different assuming an ambient temperature of 77°F.
sterilization modalities Samples of Tyvek® 2FS™ were aged according to the
Samples of Transition Tyvek 1073B and Transition Tyvek
® ®
standard ASTM F1980 using the following accelerated
1059B were aged according to the standard ASTM F1980 conditions:
using the following accelerated conditions:
• Accelerated aging (1, 3 and 5 years) at 140°F and ambient
• Accelerated aging (1, 3, 5, 7 and 10 years) at nominal RH, assuming an ambient temperature of 77°F .

Figure 29. Effects of sterilization and accelerated aging on material tensile strength (MD) for Transition Tyvek® 1073B,
Transition Tyvek® 1059B and Tyvek® 2FS™ (ASTM D5034—in lb f/4 in.). MD = machine direction

Transition Tyvek® 1073B Transition Tyvek® 1059B Tyvek® 2FS™

Year 1 Year 3 Year 5 Year 7 Year 10 Year 1 Year 3 Year 5 Year 7 Year 10 Year 1 Year 3 Year 5

120

100

80
lbf/4 in.

60

40

20

0
Pre-sterilization Ethylene Gamma* Gamma Gamma Electron beam* Electron beam Electron beam Steam* STERRAD® 100S* Vaporized
oxide (EO) @ 25 kGy @ 50 kGy @ 100 kGy @ 25 kGy @ 50 kGy @ 100 kGy @ 261°F (127°C) hydrogen peroxide*

Sterilization modality

*No results available for Tyvek ® 2FS ™.

Figure 30. Effects of sterilization

Pre-Sterilization Ethylene and
Gamma*accelerated
Gamma aging on material
Gamma tensile
Electron Beam*strength (CD) Electron
Electron Beam for Transition
Beam Tyvek® 1073B,
Steam* STERRAD ®
100S* Vapor Hydrogen
Oxide (EO)
Transition Tyvek® 1059B and Tyvek@® 25
2FSkGy™ @ 50 kGy
(ASTM D5034—in @ 100 kGy
lb f/4 in.).@CD25 kGy
= cross @ 50 kGy
direction @ 100 kGy @ 261°F (127°C) Peroxide*

Transition Tyvek® 1073B Transition Tyvek® 1059B Tyvek® 2FS™

Year 1 Year 3 Year 5 Year 7 Year 10 Year 1 Year 3 Year 5 Year 7 Year 10 Year 1 Year 3 Year 5

150

120

90
lbf/4 in.

60

30

0
Pre-sterilization Ethylene Gamma* Gamma Gamma Electron beam* Electron beam Electron beam Steam* STERRAD® 100S* Vaporized
oxide (EO) @ 25 kGy @ 50 kGy @ 100 kGy @ 25 kGy @ 50 kGy @ 100 kGy @ 261°F (127°C) hydrogen peroxide*

Sterilization modality

*No results available for Tyvek ® 2FS ™.

Pre-SterilizationEthylene Oxide (EO)

Gamma @ 25 kGyGamma @ 50 kGy
Gamma @ 100Electron
kGy Beam @Electron
25 kGy Beam @Electron
50 kGy Beam @ 100
Steam
kGy @ 261°F (127°C)
STERRAD® 100S
Vapor Hydrogen Peroxide
Section 5 Stability testing 41
5 Stability testing

Figure 31. Effects of sterilization and accelerated aging on material elongation (MD) for Transition Tyvek® 1073B,
Transition Tyvek® 1059B and Tyvek® 2FS™ (ASTM D5034—in %). MD = machine direction

Transition Tyvek® 1073B Transition Tyvek® 1059B Tyvek® 2FS™

Year 1 Year 3 Year 5 Year 7 Year 10 Year 1 Year 3 Year 5 Year 7 Year 10 Year 1 Year 3 Year 5

25

20

15
%

10

0
Pre-sterilization Ethylene Gamma* Gamma Gamma Electron beam* Electron beam Electron beam Steam* STERRAD® 100S* Vaporized
oxide (EO) @ 25 kGy @ 50 kGy @ 100 kGy @ 25 kGy @ 50 kGy @ 100 kGy @ 261°F (127°C) hydrogen peroxide*

Sterilization modality

*No results available for Tyvek 2FS .

® ™

Figure 32. Effects of sterilization and accelerated aging on material elongation (CD) for Transition Tyvek® 1073B,
Transition Tyvek® 1059B and Tyvek® 2FS™ (ASTM D5034—in %). CD = cross direction

Transition Tyvek® 1073B Transition Tyvek® 1059B Tyvek® 2FS™

Year 1 Year 3 Year 5 Year 7 Year 10 Year 1 Year 3 Year 5 Year 7 Year 10 Year 1 Year 3 Year 5

30

25

20

15
%

10

0
Pre-sterilization Ethylene Gamma* Gamma Gamma Electron beam* Electron beam Electron beam Steam* STERRAD® 100S* Vaporized
oxide (EO) @ 25 kGy @ 50 kGy @ 100 kGy @ 25 kGy @ 50 kGy @ 100 kGy @ 261°F (127°C) hydrogen peroxide*

Sterilization modality

*No results available for Tyvek ® 2FS ™.

Section 5 Stability testing 42

5 Stability testing

Figure 33. Effects of sterilization and accelerated aging on material puncture strength for Transition Tyvek® 1073B,
Transition Tyvek® 1059B and Tyvek® 2FS™ (ASTM F1342—in lbf/4 in.).

Transition Tyvek® 1073B Transition Tyvek® 1059B Tyvek® 2FS™

Year 1 Year 3 Year 5 Year 7 Year 10 Year 1 Year 3 Year 5 Year 7 Year 10 Year 1 Year 3 Year 5

3.5

3.0

2.5

2.0
lbf

1.5

1.0

0.5

0.0
Pre-sterilization Ethylene Gamma* Gamma Gamma Electron beam* Electron beam Electron beam Steam* STERRAD® 100S* Vaporized
oxide (EO) @ 25 kGy @ 50 kGy @ 100 kGy @ 25 kGy @ 50 kGy @ 100 kGy @ 261°F (127°C) hydrogen peroxide*

Sterilization modality

*No results available for Tyvek ® 2FS ™.

Pre-Sterilization Ethylene Gamma Gamma Gamma Electron Beam Electron Beam Electron Beam Steam STERRAD® 100S Vapor Hydrogen
Oxide (EO) @ 25 kGy @ 50 kGy @ 100 kGy @ 25 kGy @ 50 kGy @ 100 kGy @ 261°F (127°C) Peroxide
Figure 34. Effects of sterilization and accelerated aging on material microbial barrier for Transition Tyvek® 1073B, Transition Tyvek® 1059B
and Tyvek® 2FS™ (ASTM F2638—in % pMax with a particle size of 1 µm, flow max 2 L/min). The lower the % pMax, the better
the performance.

Transition Tyvek® 1073B Transition Tyvek® 1059B Tyvek® 2FS™

Year 1 Year 3 Year 5 Year 7 Year 10 Year 1 Year 3 Year 5 Year 7 Year 10 Year 1 Year 3 Year 5

3.5

3.0

2.5

2.0
% pMax

1.5

1.0

0.5

0.0
Pre-sterilization Ethylene Gamma* Gamma Gamma Electron beam* Electron beam Electron beam Steam* STERRAD® 100S* Vaporized
oxide (EO) @ 25 kGy @ 50 kGy @ 100 kGy @ 25 kGy @ 50 kGy @ 100 kGy @ 261°F (127°C) hydrogen peroxide*

Sterilization modality

*No results available for Tyvek ® 2FS ™.

ASTM F2638, Standard Test method for using aerosol filtration for measuring the performance of porous packaging materials as a surrogate microbial
barrier, measures the ability of a porous substrate to prevent particle penetration, which is highly correlated to microbiological spore penetration. All
materials have a face velocity where maximum percent particle penetration occurs (% pMax). The data reported in this graph is the outcome of a study
designed to evaluate the compatibility of Tyvek® with various sterilization modalities and the effect on microbial barrier properties after exposure. The
data is based on a limited number of samples and does not include long-term variability. The lower the percent penetration, the better the performance.

Section 5 Stability testing 43

5 Stability testing

Results of 1-year real-time aging study after For sterilization details, see Section 4,
different sterilization modalities “Sterilization compatibility.”

Samples of Transition Tyvek® 1073B and Transition Tyvek®

1059B were sterilized using various sterilization modalities
and aged using the conditions listed here:
• Real-time aging (1 year) at nominal conditions of 77°F
and monitored ambient RH.

Figure 35. Effects of sterilization and 1-year real-time aging on material tensile strength (MD) for Transition Tyvek® 1073B
and Transition Tyvek® 1059B (ASTM D5034—in lb f/4 in.). MD = machine direction

Transition Tyvek® 1073B Transition Tyvek® 1059B

120

100

80
lbf /4 in.

60

40

20

0
Pre-sterilization Ethylene Gamma Gamma Gamma Electron beam Electron beam Electron beam Steam STERRAD® 100S Vaporized
oxide (EO) @ 25 kGy @ 50 kGy @ 100 kGy @ 25 kGy @ 50 kGy @ 100 kGy @ 261°F (127°C) hydrogen peroxide

Sterilization modality

Figure 36. Effects of sterilization and 1-year real-time aging on material tensile strength (CD) for Transition Tyvek® 1073B
and Transition Tyvek® 1059B (ASTM D5034—in lb f/4 in.). CD = cross direction

Transition Tyvek® 1073B Transition Tyvek® 1059B

125

100

75
lbf/4 in.

50

25

0
Pre-sterilization Ethylene Gamma Gamma Gamma Electron beam Electron beam Electron beam Steam STERRAD® 100S Vaporized
oxide (EO) @ 25 kGy @ 50 kGy @ 100 kGy @ 25 kGy @ 50 kGy @ 100 kGy @ 261°F (127°C) hydrogen peroxide

Sterilization modality

Section 5 Stability testing 44

5 Stability testing

Figure 37. Effects of sterilization and 1-year real-time aging on material elongation (MD) for Transition Tyvek® 1073B
and Transition Tyvek® 1059B (ASTM D5034—in %). MD = machine direction

Transition Tyvek® 1073B Transition Tyvek® 1059B

25

20

15
%

10

0
Pre-sterilization Ethylene Gamma Gamma Gamma Electron beam Electron beam Electron beam Steam STERRAD® 100S Vaporized
oxide (EO) @ 25 kGy @ 50 kGy @ 100 kGy @ 25 kGy @ 50 kGy @ 100 kGy @ 261°F (127°C) hydrogen peroxide

Sterilization modality

Figure 38. Effects of sterilization and 1-year real-time aging on material elongation (CD) for Transition Tyvek® 1073B
and Transition Tyvek® 1059B (ASTM D5034—in %). CD = cross direction

Transition Tyvek® 1073B Transition Tyvek® 1059B

30

25

20

15
%

10

0
Pre-sterilization Ethylene Gamma Gamma Gamma Electron beam Electron beam Electron beam Steam STERRAD® 100S Vaporized
oxide (EO) @ 25 kGy @ 50 kGy @ 100 kGy @ 25 kGy @ 50 kGy @ 100 kGy @ 261°F (127°C) hydrogen peroxide

Sterilization modality

Section 5 Stability testing 45

5 Stability testing

Figure 39. Effects of sterilization and 1-year real-time aging on puncture strength for Transition Tyvek® 1073B
and Transition Tyvek® 1059B (ASTM F1342—in lb f).

Transition Tyvek® 1073B Transition Tyvek® 1059B

3.0

2.5

2.0

1.5
lbf

1.0

0.5

0.0
Pre-sterilization Ethylene Gamma Gamma Gamma Electron beam Electron beam Electron beam Steam STERRAD® 100S Vaporized
oxide (EO) @ 25 kGy @ 50 kGy @ 100 kGy @ 25 kGy @ 50 kGy @ 100 kGy @ 261°F (127°C) hydrogen peroxide

Sterilization modality

Figure 40. Effects of sterilization and 1-year real-time aging on material microbial barrier for Transition Tyvek® 1073B and
Transition Tyvek® 1059B (ASTM F2638—in % pMax with a particle size of 1 µm, flow max 2 L/min). The lower the % pMax,
the better the performance.

The lower the % pMax, the better the performance. Transition Tyvek® 1073B Transition Tyvek® 1059B

2.0

1.5
% pMax

1.0

0.5

0.0
Pre-sterilization Ethylene Gamma Gamma Gamma Electron beam Electron beam Electron beam Steam STERRAD® 100S Vaporized
oxide (EO) @ 25 kGy @ 50 kGy @ 100 kGy @ 25 kGy @ 50 kGy @ 100 kGy @ 261°F (127°C) hydrogen peroxide

Sterilization modality

ASTM F2638, Standard test method for using aerosol filtration for measuring the performance of porous packaging materials as a surrogate microbial barrier,
measures the ability of a porous substrate to prevent particle penetration, which is highly correlated to microbiological spore penetration. All materials have a
face velocity where maximum percent particle penetration occurs (% pMax). The data reported in this graph is the outcome of a study designed to evaluate the
compatibility of Tyvek® with various sterilization modalities and the effect on microbial barrier properties after exposure. The data is based on a limited number
of samples and does not include long-term variability. The lower the percent penetration, the better the performance.

Section 5 Stability testing 46

5 Stability testing

Results of combined accelerated and either Legacy Tyvek® 1073B, Tyvek® 2FS™ or one of five
real-time aging test after gamma sterilization different medical-grade papers. Tests performed were
(seal strength) seal strength and package integrity after sterilization (EO,
gamma), after accelerated aging and after conditioning
The effect of gamma sterilization and aging on seal
and subsequent transportation testing.
strength is negligible (Table XIII). Pouches of Legacy
Tyvek® 1073B and 2.5-mil polyester/polyethylene were To learn more about the effect of EO, gamma sterilization
gamma irradiated (30 kGy) and then stored at 131°F and and accelerated aging on seal strength, download the
ambient RH for a period of 10 weeks, followed by storage white paper titled “Medical packaging study—reducing the
at ambient conditions for three years and then assessed risk of failure through performance testing of packaging
for seal strength according to ASTM F88. made from various materials.”

DuPont performed an extensive study to evaluate the

performance of standard chevron pouches made with

Table XIII. Seal strength of Legacy Tyvek® 1073B after gamma sterilization following accelerated and real-time aging*,**

Seal strength lbƒ/in. (N/2.54 cm)

Pre-sterilization 0.915 (4.07)

Sterilized with 30 kGy gamma 0.949 (4.22)

Accelerated aging 2 weeks 0.931 (4.14)

4 weeks 0.856 (3.85)
6 weeks 0.953 (4.24)
8 weeks 0.887 (3.95)
10 weeks 0.848 (3.77)

Real-time aging 3 years 0.778 (3.46)

*B ased on data generated on Legacy Tyvek ® 1073B. Transition Tyvek ® 1073B has been proven to be functionally equivalent. Legacy Tyvek ® is either Tyvek ® 1073B or Tyvek ® 1059B
produced on the original manufacturing lines. Transition Tyvek ® is either Tyvek ® 1073B or Tyvek ® 1059B produced on the newer manufacturing lines.
**This data is an example based on one possible packaging material configuration. Other material combinations may behave differently.

Section 5 Stability testing 47

6 Package system performance testing

Mechanical properties As shown by the data, Legacy Tyvek® 1073B and Tyvek®
2FS™ showed the best microbial barrier performance. On
A sterile barrier system must withstand many challenges
the other hand, three of the four types of medical-grade
during sterilization, handling, storage and distribution.
paper showed a significant decrease in microbial barrier
Physical properties provide an important indication of the
performance after gamma sterilization, environmental
probability that the material, as part of the packaging, can
conditioning and transportation testing compared to
stay intact throughout the life cycle.
pre-sterilization. This decrease in microbial barrier
See Section 5, “Stability testing” for additional information performance was mainly linked to creases and punctures
on the effects of sterilization and accelerated/1-year in the material. Details are contained in the white
real-time aging on material tear strength, elongation and paper titled “Medical packaging study—the impact of
puncture strength for Transition Tyvek® 1073B, Transition sterilization and transportation testing on the microbial
Tyvek® 1059B and Tyvek® 2FS™. barrier of different materials.”
Transport simulation and subsequent testing Storage requirements
To demonstrate that Tyvek can withstand very high
®
Because Tyvek® is made of high-density polyethylene
environmental challenges, DuPont conducted an extensive (HDPE) filaments, it is not affected by climatic changes in
performance testing study to evaluate the performance of humidity, temperature or atmospheric pressure. Exposure
standard chevron pouches made with either Legacy to UV light should be limited to less than one month.
Tyvek® 1073B, Tyvek® 2FS™ or one of five different medical- Normal shipping, handling and storage conditions should
grade papers. Seal strength and package integrity tests be used.
were done after sterilization (ethylene oxide [EO], gamma),
Packaging exposed to liquid
after accelerated aging and after conditioning and
subsequent transportation testing. When medical-grade paper absorbs moisture, its strength
and puncture resistance are reduced. This can greatly
The study showed that loss of integrity after transportation
influence package performance, especially during
testing was reported for three of the five types of medical-
distribution. In sharp contrast to medical-grade paper,
grade paper that were evaluated in this study. The
Tyvek® maintains its superior strength both wet and dry.
integrity failures, which were only observed after gamma
sterilization, were all linked to punctures and/or creases in Tyvek® has the advantage because it is hydrophobic and
the paper. All pouches made with Legacy Tyvek® 1073B or holds out water until a fairly high pressure (see Figure
Tyvek® 2FS™ maintained integrity. 12 in Section 1, “Why is Tyvek® the preferred choice for
sterile barrier systems?”). Occasionally, medical device
Complete details about the scope of the study and the
and pharmaceutical packages are subjected to adverse
materials tested can be found in the white paper titled
conditions that allow them to get wet, such as rain on
“Medical packaging study—reducing the risk of failure
a loading dock or flooding. When this occurs, the time
through performance testing of packaging made from
of exposure and severity are not typically known, nor
various materials.”
has such exposure been tested during package design.
To demonstrate that Tyvek® keeps its microbial barrier We believe water exposure under these types of
even under rigorous conditions such as transport, scenarios would constitute damage relative to the typical
microbial barrier testing was conducted according to manufacturer labeling “sterile unless opened or damaged.”
ASTM F2638, before and after sterilization (EO, gamma) Each device manufacturer must determine based on
and subsequent transportation testing. individual risks and requirements if such wetted packages
are still fit for use.

Section 6 Package system performance testing 48

7 Application guidance

Guidelines for printing Printing plates for flexography

Styles of Tyvek® for medical and pharmaceutical packaging Selecting the appropriate type of printing plate is
can be printed using standard commercial printing dependent upon the nature of the printing job. General
equipment and suitable inks. Because of the unique printing best practices should be followed to optimize the
requirements for medical and pharmaceutical packaging, conditions of the pressroom for ultimate performance.
these styles have no antistatic coating and are not corona Printing variables include the plate, cushion, ink and
treated. Therefore, special steps must be taken to obtain anilox. As always, it is best to clean the printing plate with
optimum printing results. When printing on Tyvek® medical 100% alcohol prior to inking to enhance ink transfer.
and pharmaceutical packaging styles, we recommend For printing solids, type and other fine detail-oriented
testing before proceeding with production operations. images, it is best to use a medium durometer plate
For additional information about printing on Tyvek®, mounted on a medium firm cushion tape. For images that
refer to the Tyvek® users manual and the Tyvek® for include fine line screens with dots, it is best to use a higher
Graphics website. durometer plate. This should be mounted on a medium
firm cushion tape.
Flexographic printing guidelines
For both, anilox selection should be based on a line
Flexography is the recommended technique for printing
screen volume that does not over-ink the plate. Please
on Tyvek® medical and pharmaceutical packaging styles.
seek manufacturer’s guidelines for viscosity, pH and
For best results, use the smooth side of the sheet. The
other transfer properties that are dependent on your ink
difference between the rough (“wire”) side and the smooth
application and resistance properties.
side is minor, but can usually be felt. Rolls supplied directly
from DuPont are wound smooth side out. Rolls supplied Recommended printing plates:
from a sterile packaging manufacturer (SPM) may be
• Digital Solvent—use DuPont™ Cyrel® EASY ESX or
wound differently. Be sure to check with your SPM or
Cyrel® EASY EPR
supplier to determine how your rolls are wound.
• Digital FAST—use Cyrel® EASY EFX or Cyrel® DFP
To help you determine the rough from the smooth side, a
simple six-step procedure has been developed. For details, • Analog—use Cyrel® NOWS or Cyrel® EXL
see “Determining the rough vs. smooth side of Tyvek®.”
Other important recommendations are listed here. Inks for flexography
It is important to not only choose the proper ink for
Press conditions for flexography
the process, but to verify the suitability of the ink in
Ensuring optimum press conditions will help prevent applications where direct contact with the medical device
sheet distortion, registration problems in multi-color work, is likely.
softening of adhesives and ink pick-off.
• Alcohol-based polyamide inks—These solvent-based
• Tensions—Keep tensions below 0.75 lb/in. of width. inks typically provide the best adhesion and rub
resistance. Adding microcystalline wax will reduce
• Temperatures—Maintain web temperatures below 175°F.
the offsetting.
• Chilled rolls—Use chilled rolls before windup.
• Water-based inks—These inks make it possible to
• Reduce the web temperature prior to wind-up on a chill achieve high-quality results while complying with
roller. This helps to prevent blocking and minimizes environmental regulations.
distortion, and is essential for printing on Tyvek® medical
and pharmaceutical packaging styles.

Section 7 Application guidance 49

7 Application guidance

Lithographic printing guidelines • Extra-strong colors—Use extra-strong colors to keep

Although flexography is the recommended method for ink film thickness to a minimum (<0.3 mil). This will help
printing on Tyvek® medical and pharmaceutical packaging minimize sheet distortion and dot gain.
styles, offset lithography can produce acceptable print • Tint creation—Use opaque white rather than an
quality. For best results, use the smooth side of the sheet. extender when creating tints to minimize the
The difference between the rough (“wire”) side and the appearance of fiber swirl.
smooth side is minor, but can usually be felt. For details,
see “Determining the rough vs. smooth side of Tyvek®.” • Fountain solution—Maintain fountain solution at a
minimum level. Either conventional water or alcohol/
Rolls supplied directly from DuPont are wound smooth water dampening systems can be used. Alcohol
side out. Rolls supplied from an SPM may be wound substitutes also work well. Do not increase the ink
differently. Be sure to check with your SPM or supplier to volume if your images appear dull or washed out.
determine how your rolls are wound. Instead, reduce the amount of dampening solution in
the fountain.
Offset blankets for lithography
• Drying—Litho inks dry more slowly on Tyvek® than they
Selecting the appropriate type of blanket to use will
do on paper, so be sure that pile height does not exceed
depend on whether or not the Tyvek® is coated.
20 in. Winding the sheets and maintaining the fountain
• For adhesive-coated Tyvek®—Use conventional offset solution at a pH between 4 and 5 can accelerate drying.
blankets of medium hardness.
More information about ink and printing machine
• For uncoated Tyvek —Use compressible offset blankets.
® manufacturers familiar with the unique requirements of
printing on Tyvek® medical and pharmaceutical packaging
Squeeze recommendation for lithography styles can be obtained by contacting your local DuPont
Applying an additional 3 mil to 4 mil of squeeze between representative.
the blanket and back cylinder is required compared to
Special notes for adhesive-coated Tyvek®
that used for paper of equivalent average thickness.
This additional impression, coupled with the When selecting offset inks, it is important to advise the
compressibility of Tyvek®, compensates for possible ink supplier if the Tyvek® has an adhesive coating because
thickness variations of Tyvek®. special ink formulations may be required to prevent ink
set-off to the coated surface. In some cases, printing is
Inks for lithography done on the adhesive side. This also should be discussed
It is important to not only choose the proper ink for with the ink supplier to ensure optimum compatibility
the process, but to verify the suitability of the ink in between the ink and the coating.
applications where direct contact with the medical
device is likely. In addition, follow these specific
recommendations for printing on Tyvek® medical and
pharmaceutical packaging styles.
• Low-solvent-content inks—Use inks with <3% volatile
solvent because hydrocarbon solvents found in many
litho inks tend to swell and distort Tyvek®. These inks
also release fewer volatile organic compounds (VOCs)
compared to traditional offset inks.

Section 7 Application guidance 50

7 Application guidance

Variable information printing thermal transfer printing on Tyvek® tends to produce D-C
ANSI bar code quality. If a high-density bar code is needed,
The need to print variable information on packages has
or a higher-quality bar-code rating is specified, a label
resulted in an increased use of electronically controlled
should be used.
printing processes. These electronic devices can output
variable information such as: lot, production date,
Ink jet printing
sequential numbering, product codes and bar codes.
Tyvek® medical and pharmaceutical packaging styles are Tyvek® medical and pharmaceutical packaging styles have
compatible with some of these processes. been printed successfully using continuous and drop-on-
demand ink jet printers. However, because Tyvek® is made
Thermal transfer printing of high-density polyethylene (HDPE) and does not absorb
moisture, solvent-based inks are preferred. Some water-
The most common process for printing variable
based inks are slower drying and tend to feather on Tyvek®,
information is thermal transfer. This process uses heated
pins to activate a pigmented wax, resin or wax/resin blend resulting in a blurry image. Acceptable results have also
that is carried on a ribbon. The image is created when the been achieved with ultraviolet (UV) and change-of-phase
molten ink transfers to the substrate. inks, which cure almost instantly. Typically, 200- to 300-dpi
print heads are used.
Wax ribbons give the best results for Tyvek® medical
and pharmaceutical packaging styles (which are not Laser (electrostatic) printing
corona treated). The image durability is marginal. If more
Conventional laser printing is not recommended for Tyvek®
durability is required, a wax/resin blend ribbon should be
because the high temperatures used to set the toner
used. A 90/10 wax/resin blend ribbon yields good results.
distort the Tyvek® during normal printing and will melt
This blend ribbon may need to be custom manufactured
the Tyvek® if a jam occurs. Cool-process (flash-fusion) laser
because many ribbon manufacturers only stock 50/50
printers are compatible with Tyvek®; however, the toner
blend ribbons.
transfer efficiency is marginal and the printed image is not
Excellent results in printing alpha-numeric information as sharp as it is with thermal transfer or ink jet printers.
have been achieved using 300- to 600-dpi printers.
Because of the inherent thickness variability of Tyvek®,

Section 7 Application guidance 51

7 Application guidance

Printing assessment—Barcode readability tests illuminated square indicates the area where it reads.
The 2D imager can read both 1D and 2D codes.*
Unique device identification (UDI) requires the printing of
complex barcodes. DuPont conducted barcode readability • 2D DPM reader (Direct Part Marking)—The core of a
tests to demonstrate that the printing of barcodes directly DPM reader is the same as a regular 2D imager. The
on Tyvek® shows good results. Please note that results may differences are found in the reader’s optics, decoding
vary when using different printing equipment or other software and illumination, which are altered specifically
barcode readers than those used in this study. for DPM codes to read contrast on these difficult
materials. DPM codes are often applied on reflective
Both flexography and thermal transfer printing
surfaces such as metal and plastic.*
technologies were assessed on Transition Tyvek® 1073B.
The samples were printed on versatile test equipment, *Information supplied courtesy of OPAL Associates B.V.

which can be switched from one printing technology to Barcode readability test details:
another in a few minutes by simply changing the
printing modules. • Result is a pass (= readable) or a fail (= not readable)

For the barcode readability test, three different types of • Four different barcodes have been tested
barcode readers were used: • The barcodes have been selected according to GS1
• Regular 1D laser scanner—A standard range laser standards; size and details are listed in Figure 41
barcode scanner can only be used for reading 1D • Six samples per barcode type have been scanned
barcodes by pointing the laser beam over the
barcode horizontally.* • 6P/6 means: Six pass for six scanned barcodes

• 2D barcode imager—A 2D barcode imager operates • 0P/6 means: Zero pass for six scanned barcodes
as a camera with barcode decoding capabilities. An

Figure 41. Barcode readability results for Transition Tyvek® 1073B.

EAN 13 GS1 128 GS1 DataMatrix GS1 DataMatrix

Flexographic printing
2D Barcode
1D Barcode 1D Barcode Symbol size: 18 x 18 Symbol size: 18 x 18
Size: 21 x 8 mm Size: 37 x 13 mm Data region size: 9 x 9 mm Data region size: 4.5 x 4.5 mm
Barcode readability with Transition Transition Transition Transition
handheld barcode scanner Tyvek® 1073B Tyvek® 1073B Tyvek® 1073B Tyvek® 1073B
Regular 1D laser scanner 6P/6 0P/6 N/A N/A
2D barcode imager 6P/6 5P/6 6P/6 5P/6
2D DPM reader 6P/6 0P/6 6P/6 5P/6

GS1 128 GS1 DataMatrix

Thermal transfer printing

2D Barcode
1D Barcode Symbol size: 12 x 12
Section 7 Application guidance 52
Size: 55 x 12 mm Data region size: 9 x 9 mm
Barcode readability with Transition Transition
handheld barcode scanner Tyvek® 1073B Tyvek® 1073B
Regular 1D laser scanner 6P/6 N/A
2D barcode imager 6P/6 6P/6
2D DPM reader 6P/6 6P/6

Section 7 Application guidance 52

7 Application guidance

Labeling evaluation of heat seal curves, depending on the

complexity of the process and parameters. The objective
A number of adhesives can be used to glue spunbonded
is to define an operating (sealing) window with validated
olefin, either to itself or to other substrates.
minimum, nominal and maximum sealing conditions. This
Water-based synthetic adhesives, such as ethylene/vinyl not only results in a heat sealing process that consistently
acetate adhesives and the acrylic pressure-sensitive produces acceptable seals, but also can optimize energy
adhesives, work well with Tyvek®. The synthetic adhesives output and operational throughput and efficiencies.
that contain low-molecular weight materials can act as
Sealing temperature
solvents at elevated temperatures, causing swelling
and wrinkling. The heat sealing process, as previously described, marries
two materials and creates a bond. To achieve this bond,
Polyurethane adhesives provide optimum adhesion, one of the materials typically carries a surface sealant
flexibility and water resistance for adhering Tyvek® to layer. The heating elements of heat seal packaging
itself and to a variety of substrates. Hot melt polyamide equipment are raised to a temperature high enough to
adhesives form good bonds to Tyvek® with a variety either melt or activate the sealant.
of materials.
In the case of packaging made of Tyvek® and film, the
The first step in choosing an adhesive is to verify if any of
sealant is either on the Tyvek® side in the form of a
the components may interact with Tyvek®. Consultation
heat seal coating or on the film side. It is important to
with the adhesive manufacturer is recommended.
ensure that the respective coating, film and sealant are
For optimized performance during gas sterilization, it is compatible with the chosen sterilization method. There
important to keep enough uncovered porous area to allow are different types of coatings and films with sealant
for the sterilization gases to enter the package and escape. available on the market that work well with Tyvek®.
Contact your local DuPont representative to learn more
For additional information, see “Chemical resistance” in
about potential suppliers.
Section 2, “Tyvek®—properties.”
Temperatures must be high enough to activate the sealant
Heat sealing guidelines layer, while not overheating the surface of the
The resultant material bond and seal strength of a heat material and inducing extreme transparentization. The
seal packaging process depends on several factors, actual temperature, as well as the distribution of the
including: sealing temperature, sealing dwell time, sealing temperature should be verified using sensor paper or more
pressure, characteristics of the sealant, the sealing sophisticated electronic sensor technologies.
machine and even the test method used to measure the Depending on the activation temperature of the sealant,
seal strength. raising the temperature and lowering the dwell time or
Seals must be strong enough to withstand the rigors lowering the temperature and raising the dwell time could
of shipping, handling and storage, yet at the same time produce more consistent seals without transparentizing
facilitate easy access for the end-user to open the sterile the Tyvek®.
package using aseptic presentation techniques. Optimizing Sealing dwell time
the heat sealing process and consistently producing
Sealing dwell time refers to the time the heating elements
packages with the appropriate seal strength is of critical
of a packaging process (clamps, plates, bars, etc.) are
importance because it can have a direct impact 0on
in direct contact with the substrate(s). It can be either
product efficacy and patient safety.
one-sided or two-sided heating. The two materials
The primary heat seal factors of temperature, time come together to form a bond or seal. It is important to
and pressure are interactive. A change or tweak in one understand how the equipment measures the dwell time
typically requires a change or tweak in one or more of the to determine “true dwell time,” which is when the webs
other factors. A balance between time, temperature and are actually pressed together. That’s because controls
pressure must be met to achieve the desired seal strength, for heat sealing equipment vary and cycle time may or
seal integrity, visual seal transfer and desired may not include travel time for the machine to engage
opening behavior. into its final closed position. Any variation in the rates of
materials reaching their seal initiation temperature, even
It is recommended to optimize the heat sealing process
by fractions of a second, can have a measureable effect on
using tools such as Design of Experiments and the
seal strength.

Section 7 Application guidance 53

7 Application guidance

Sealing pressure • Pressure not defined or adjusted in relation to seal

surface when switching seal designs (applied pressure
The third key factor of heat sealing is the pressure at
changes based on the amount of seal surface)
which the equipment brings together and holds the two
materials together to form the seal. It is important to • Material thickness or variation
know the actual pressure the substrates are exposed
Sensor paper or more sophisticated electronic sensor
to because this value is often not equivalent to the input
technologies can be used to detect variations in platen
pressure or the set point on the machine controls. There
temperature or uneven pressure.
are many techniques to measure sealing pressure—
from sensor paper to more sophisticated electronic To produce uniform seal strengths resulting in clean,
sensor technologies. peelable seals that are strong enough to withstand the
rigors encountered during shipping, handling and storage,
For most heat seal materials, studies have shown that
it is important to develop a robust heat sealing process
pressure is the least significant of the three factors
by optimizing the temperature, dwell time and pressure
required to make a heat seal. Pressure must be sufficient
for specific material combinations. An operating (sealing)
to ensure proper contact area between the materials. If
window must be properly defined and validated.
pressure is too high while reaching the sealant’s melting
point, outward flow of the sealant may occur and affect
The unique structure of Tyvek®
the package’s opening behavior.
The DuPont™ Tyvek® Medical Packaging Transition Project
Other factors (MPTP) testing and global market feedback have shown
The three main factors for heat sealing—temperature, that sealing performance is exceptional using properly
dwell time and pressure—can produce significant validated processes. It is recommended to run three
variability in seal strength. However, there are other different lots of material for validation purposes.
factors related to time, temperature and pressure that can
The seal strength distribution graph (Figure 42)
also affect heat seals. Some common factors include:
demonstrates an equal temperature transfer. This example
• Variation in platen temperature—“hot spots” or is based on one material combination (uncoated Transition
“cold spots” Tyvek® 1073B sealed to a 100-gauge bi-axial nylon with
HDPE film). The seal strength has been tested according
• Non-uniform heat transfer due to uneven contact or
to the ASTM F88 free tail method and averages have been
pressure caused by a warped or misaligned platen
calculated from more than 500 data points.

Figure 42. Pouch seal strength distribution for uncoated Figure 43. Microscopic view of Tyvek®
Transition Tyvek® 1073B sealed to a 100-gauge bi-axial nylon with (200x magnification).
high-density polyethylene (HDPE) film (ASTM F88).

Section 7 Application guidance 54

7 Application guidance

Determining the rough vs. smooth side The rough side comes into contact with the belt during
of Tyvek® the spinning process and, therefore, shows a pattern.
See Figures 44 and 45 for microscopic photos showing
Tyvek® material has two sides; one is called the “smooth”
the difference between the smooth vs. rough side of
side and the other is called the “rough” side. When looking
(uncoated) Tyvek®.
at the two sides, a difference in structure can be perceived.

Figure 44. Microscopic view of the smooth side of Tyvek® Figure 45. Microscopic view of the rough side of Tyvek®
(25x magnification). (25x magnification).

Section 7 Application guidance 55

7 Application guidance

When sealing to Tyvek®, it is important to always seal to Tyvek® can also be supplied in coated form from SPMs.
the rough side. Sealing to the smooth side may result in The coating is usually applied on the rough side of Tyvek®.
fiber tear. Typically, rolls of Tyvek® are wound smooth side Please ask your supplier for more information.
out when they are shipped.
If needed, the following steps can be used to verify which
way the roll is wound.

1 4

Fold back the edge of the Tyvek® approximately 6 in. and crease flat. Using a felt tip pen or marker, draw a line on one side of the tape,
Note: If the roll is wound correctly with the smooth side out, the folded extending the line onto the Tyvek® for easy identification.
area will be the rough side.

2 5

Cut a strip of 1 in. wide ARclad® AR-516 tape approximately 8 in. long. Place Peel off the strip of tape.
it on the “seam” so that approximately 1 /2 in. is on the smooth side and 1 /2
in. is on the rough side.

Rough side

Smooth side
3 6

Smooth the tape down by running your finger along the “seam” one or two Look at the adhesive side of the tape and note which half shows evidence
times. Use moderate pressure. of fiber tear. This will be the smooth side. Note: If you have any doubt, take
the existing flap and fold it back on itself approximately 2 in. to create a
new “seam.” Then, repeat steps 2 through 6.

Section 7 Application guidance 56

7 Application guidance

Package quality evaluation Microbial barrier:

The most important requirement for a medical package • ASTM F1608 Standard Test method for microbial
is to maintain sterility until the point of use. It must be ranking of porous packaging materials (exposure
demonstrated that a sterile barrier system (SBS) can chamber method)
keep its integrity through all the steps of the value chain. • ASTM F2638 Standard Test method for using aerosol
The base condition is a validated packaging process that filtration for measuring the performance of porous
produces a good quality seal and thus allows for barrier packaging materials as a surrogate microbial barrier
performance against the migration of microorganisms.
A well-defined testing strategy is the basis for the
There are different test methods used for package quality qualification of a safe and reliable SBS.
evaluation on the market. Below are a few examples.
These and more test methods are listed in Annex B of ISO DuPont conducted an extensive study to evaluate the
11607 Standard Packaging for terminally sterilized medical performance of standard chevron pouches made with
devices. For additional information, consult the ASTM either Legacy Tyvek® 1073B, Tyvek® 2FS™ or one of five
F2097 Standard Guide for Design and Evaluation of Primary different medical-grade papers. Tests performed were
Flexible Packaging for Medical Products . seal strength and package integrity after sterilization (EO,
gamma), after accelerated aging and after conditioning
Strength of package closures: and subsequent transportation testing.
• ASTM F88 Standard test method for seal strength of
In a second study, microbial barrier testing was conducted
flexible barrier materials
before and after sterilization (EO, gamma) and subsequent
• ASTM F1140 Standard test methods for internal transportation testing.
pressurization failure resistance of unrestrained packages
To learn more, download the white papers titled “Medical
• ASTM F2054 Standard test method for burst testing of packaging study—reducing the risk of failure through
flexible package seals using internal air pressurization performance testing of packaging made from various
within restraining plates materials” and “Medical packaging study—the impact of
sterilization and transportation testing on the microbial
Seal integrity:
barrier of different materials” found at our Medical
• ASTM F1886 Standard test method for determining Packaging Knowledge Center.
integrity of seals for medical packaging by
visual inspection
• ASTM F1929 Standard Test method for detecting seal
leaks in porous medical packaging by dye penetration
• ASTM F2096 Standard test method for detecting gross
leaks in medical packaging by internal pressurization
(bubble test)
• ASTM F2228 Standard test method for non-destructive
detection of leaks in packaging which incorporates
porous barrier material by CO2 tracer gas method
(porous materials to be covered)
• ASTM F2338 Standard test method for nondestructive
detection of leaks in packages by vacuum decay method
(porous materials to be covered)
• ASTM F3004 Standard test method for evaluation of seal
quality and integrity using airborne ultrasound

Section 7 Application guidance 57

7 Application guidance

Slitting of Tyvek® Because Tyvek® 2FS™ contains TiO2 opacifier, it may wear
slitting blades faster than other Tyvek® medical and
Tyvek® filaments are very strong. When slitting Tyvek®, all
pharmaceutical packaging styles. Ceramic blades can be
cutting parts should be kept clean and sharp, with true,
used to slit Tyvek® 2FS™.
well-supported, nick-free edges to obtain a clean cut.
To reduce the buildup of static, antistatic equipment, Processing/troubleshooting guidelines
such as ionizers to control static charges on the material, Avoiding fold problems
can be used.
A sheet of Tyvek® is a monolayer material that is heat
There are different slitting methods and knives used treated or bonded on both sides. This treatment makes the
to cut Tyvek®: exterior less flexible than the interior of the structure and
• Crush cutting—a steel knife with a sharp, slightly allows the monolayer material to perform more closely to
rounded edge lasts longer than one with a pointed edge a multilayer structure (Figure 46).

• Other slitting methods—a sharp edge is recommended: When any sheet structure is bent, the outer surface is
placed in tension while the inner surface is placed in
Ƿ S
 hear cut—steel blades such as those used in compression. The tighter the bend, the greater these
automated form-fill-seal machines forces become. If these loads become excessive, the
Ƿ R
 azor cut—steel, ceramic or tungsten filament structure holding the two layers together will
carbide blades succumb to the forces and the inner surface will buckle
inward (Figure 47).
Ƿ Die-cut—steel rule or male/female dies

Figure 46. Pictorial representation of ™ Tyvek® Figure 47. Pictorial representation of Tyvek® during
during package opening. opening at an extreme angle.

Tyvek®, a monolayer material, acts like a multilayer material represented An extreme fold or bend puts the exterior surface in tension and the
by the green/yellow/green layers. interior surface in compression, causing the interior of the sheet
to buckle.

Section 7 Application guidance 58

7 Application guidance

The result will be the formation of a delaminated area differentiate a channel (Figure 49) from sheet separation.
along the center line of the sheet of Tyvek®. This is Lab technicians must follow the ASTM protocol when
commonly seen when the flexible edge of the pouch performing the test to ensure “wicking” is not produced.
seal is bent or folded to fit into a shelf carton. With the
If dye is left too long in the pouch made with Tyvek®, the
pouch film on the outside of the bend, all of the force to
Figure 49. Channel in seal determined during dye penetration
make the fold is converted to compression loads on the
testing (ASTM F1929:2003).
inner surface of the sheet of Tyvek®, which may lead to
separation within the interior of the sheet, commonly
referred to as sheet separation (Figure 48). However, it
has been demonstrated that this phenomenon does not
compromise the integrity of the package.
Figure 48. Micrograph of folded Tyvek® showing sheet
separation, a phenomenon that does not compromise the
integrity of the package.

dye begins to wick through the material (Figure 50).

Figure 50. Wicking occurs when dye is left too long in the pouch
during ASTM F1929:2003 testing.

Specifically, samples were designed that would allow a

microbial aerosol challenge to be applied to both the sheet
of Tyvek® and the seal section containing the delaminated
area. The samples were placed in the apparatus used in the
ASTM F1608 and ASTM F2638 microbial barrier tests. No
reduction in log reduction values (LRV) for ASTM F1608 or
percent penetration rates for ASTM F2638 was observed.
Sheet separation is typically encountered during the
qualification phase of package testing. During underwater
bubble leak testing (ASTM F2096:2002) a pouch with sheet
separation will produce a stream of air bubbles that appear
to be a channel in the seal. This result requires additional
lab testing to determine if there is truly a channel in the
seal or if sheet separation has produced a false positive.
A dye penetration test (ASTM F1929:2003) is used to

Section 7 Application guidance 59

7 Application guidance

Another way to confirm sheet separation vs. a channel • Choose the right sealant (either on the film or on the
is to reserve the pouches after dye testing, wait until the Tyvek® side)
residual dye has dried and then peel the pouch open to
• Adjust the sealing parameters
reveal either dye in the sealed area, indicating a channel in
the seal, or no dye, indicating sheet separation. • Add a sheet of Teflon® to the top of the heat seal platen

In addition to the possible phenomena of internal sheet • Control the pressure and temperature distribution on
separation, there is another point to consider when folding the sealing platen (sensor paper or more sophisticated
Tyvek® sterile barrier systems (SBS): the edge of the fold electronic sensor technologies can be used)
may be in direct contact with the secondary packaging
• Check for contamination on the sealing platen
(shelf carton) and result in severe abrasion points.
Although Tyvek® resists abrasion better than other porous • Check the condition of the sealing platen and
materials, severe abrasion can cause holes in any material. sealing rubber

One example is a pouch folded over the edge of a “sharp” • Select an appropriate durometer/stiffness of the sealing
tray in a shelf carton exposed to vibrations during rubber (talk to the supplier of your packaging machine)
transport (Figure 51).
Seal integrity testing will help to assess the risk linked to
Figure 51. Pouch folded over the edge of a rigid tray. any seal issues.
Fiber tear
Even though Tyvek® is much stronger than most other
porous materials, fiber tear and/or delamination may
occasionally occur. A sharp bend of Tyvek® as it is
being peeled from the film web, rough cut edges, high
sealing temperatures and other factors can lead to fiber
tear, which usually results in a partial delamination of
the Tyvek® sheet. (See “Avoiding fold problems” for a
description of how this delamination occurs.)
To eliminate fiber tear, the first option is to reduce the seal
strength. If this does not produce the desired result, you
can consider either of the following possible solutions:
• Use a more flexible film that will not force Tyvek® to
bend as much when the seal is opened.
or
• Use a heavier basis weight of Tyvek® that has a greater
The best way to avoid sheet separation, false positives and bend radius and a lower tendency to delaminate.
abrasion points is to avoid folding pouches. However, if the and
package fold is necessary, opt for a gentle curl instead of a • Ensure that you use an appropriate sealant either on
true fold. the Tyvek® or on the film side to allow for good
For more information, read “Porous Sterile Barrier Integrity peel functionality.
Testing: Failure Anomalies,” an article that was published
in the January 2006 issue of MD&DI magazine. This article Cutting and slitting Tyvek®
can be found in the magazine’s online archive. Blades, cutting wheels and dies need to be maintained so
they are sharp and free of nicks and other imperfections
Over sealing or no seal transfer
that could cause rough, irregular cuts. Irregular edge cuts
Over sealing or insufficient seal transfer may occasionally could enable films or foils to adhere to filaments from
occur. A proper investigation is important. the center region of the Tyvek® sheet during heat sealing.
How can this be avoided? This attachment to individual filaments, as opposed to
the bonded Tyvek® surface, could cause fiber tear and/or
delamination during peeling.

Section 7 Application guidance 60

7 Application guidance

Forming pouches Sealing lids to trays and form-fill-seal (FFS) packaging

Tyvek should not be sealed all the way to its edge because
®
Several factors cause or greatly increase the occurrence
this could allow adhesive to flow around the edge of the of fiber tear when opening lids sealed to either rigid or
bonded Tyvek® surface and attach to individual filaments. flexible thermoformed trays. Eliminating these factors can
This attachment to individual filaments, as opposed to greatly reduce the probability of fiber tear and allow for a
the bonded Tyvek® surface, could cause fiber tear and/or clean peel opening.
delamination during peeling.
Figure 53 demonstrates various lid placements on a tray
When forming multiple pouches across the web, tooling and the predicted result after peeling. A leading cause of
should be designed so that an unsealed area of at least fiber tear is improper lid placement and/or improper
1 mm resides between adjacent pouches. Singularizing lid size.
pouches across the web should be performed in unsealed
areas between pouches. Any edge trim removed from
outside pouches on the web after sealing should be cut off
in an unsealed area.

Figure 52. Example of an unsealed area on a tray.

Figure 53. Prediction of fiber tear based on lid alignment on tray.

Unlikely fiber tear Possible fiber tear Highest risk of fiber tear
Blue = Tray White = Lid

Section 7 Application guidance 61

7 Application guidance

Lids should not be sealed all the way to the edge of Additionally, if the edge of the lid has a microscopic nick or
the tray (Figure 52). This could allow adhesive to flow rough cut edge, this can act as an initiation point for a tear
around the edge of the bonded Tyvek® surface and attach when the lid is peeled.
to individual filaments. This attachment to individual
Tooling should be designed so that an unsealed area of at
filaments, as opposed to the bonded Tyvek® surface, could
least 1 mm resides between adjacent trays in the case of
cause fiber tear and/or delamination during peeling.
FFS packaging, also known as a “skirt” (Figure 54), or in the
case of an individual thermoformed tray, the lid overhangs
the outer tray edge by at least 1 mm.

Figure 54. Multiple cavity thermoform with “skirt” seal or gap between sealed areas.

Forming Sealing Filling

Unsealed gap avoids the risk of delamination.

Section 7 Application guidance 62

7 Application guidance

In an experiment conducted by DuPont, lid placement and the tray. A proper adhesive break leaves the heat seal
was a strong predictor of whether or not the lid would coating on the tray (white witness mark) and allows the lid
experience fiber tear during opening (Figures 55 and 56). to peel cleanly away from the tray. An oversized lid allows
The physics of peeling open a lid from a tray requires an for clean initiation of the peel.
adhesive break of the bond between the heat seal coating

Figure 55. DuPont sealing experiment to test the effect of lid placement on fiber tear.

Proper lid placement with minimum of 1-mm lid overhang all the way around the tray. All 32 samples showed consistent seal area and no delamination
during opening.

Figure 56. Results of improper lid placement during DuPont sealing experiment.

There was no overhang; lid length and width dimensions were equal to the tray seal area dimensions. A total of 26 out of 32 samples experienced fiber tear
ranging from minimal to extreme.

Section 7 Application guidance 63

7 Application guidance

Summary—How to reduce the risk of fiber tear and/or Recycling of Tyvek®

delamination
As for ecological responsibility, Tyvek® is an excellent
• Use a more flexible film or a heavier basis weight choice. This lightweight, durable material can be an
of Tyvek® effective way to conserve resources and demonstrate
• Choose the right sealant (on the Tyvek® or the film) environmental stewardship. Tyvek® is produced under
verified environmental management policy according to
• Avoid over sealing; adjust the sealing parameters ISO 14001.
(seal strength)
Tyvek® can be recycled at local recycling facilities that
• Use only sharp, nick-free knives for cutting accept flexible HDPE waste according to local legislation.
• Do not cut through the seal; place the lid accordingly The items sent for recycling must not have been in contact
on the tray with any hazardous substance.
DuPont and other leading companies in the healthcare,
Controlling static charges during recycling and waste management industries have come
converting operations together to form the Healthcare Plastics Recycling Council
Static electricity is an accumulation of electrical charges (HPRC). The technical coalition is working to inspire and
on a surface (positive or negative). There can be an enable sustainable, cost-effective recycling solutions for
overabundance of electrons (negative charges) or a plastic products and materials used in the delivery of
deficiency of electrons (positive charges) on the surface healthcare. Visit the HPRC website for more information.
of an insulating material such as nonwoven material or
Mechanical recycling
plastic film. A charge can also accumulate on a conductor,
such as a metal roll, machine part or the human body, if it Tyvek® or products made from Tyvek® can be mechanically
is isolated from electrical ground. recycled into products such as underground cable
protection piping, automotive parts, blown film, packaging
Tyvek® for medical and pharmaceutical packaging cores and trays. Products made from Tyvek® that are
applications does not have an antistatic treatment applied. printed, glued, welded or sewn can also be recycled, as can
When converting Tyvek® on processing equipment (such as Tyvek® that has been extrusion coated or laminated with
a lid cutting machine), static charge occurs. an item from the same polymer family.
Therefore, it is strongly recommended to install Chemical feedstock recycling
appropriate antistatic equipment such as ionizers
to control static charges on the material. There are Tyvek®, together with other synthetic waste, can be
specialized companies that can provide support in processed through chemical feedstock recycling. The
helping you to define the correct measures. Additional chemical components are separated and these basic
information can be obtained by contacting your local raw materials are recovered for reuse, thus reducing
DuPont representative. consumption of new oil resources.

Section 7 Application guidance 64

A1 Test methods and standards
Table XIV. Test methods and standards

Standard/reference Description
AATCC TM 127 Water resistance: hydrostatic pressure test
Standard test method for tearing strength of fabrics by falling-pendulum (Elmendorf-type)
ASTM D1424
apparatus
ASTM D2724 Standard test methods for bonded, fused, and laminated apparel fabrics

ASTM D4169-09 Standard practice for performance testing of shipping containers and systems

ASTM D4332-01 Standard practice for conditioning containers, packages, or packaging components for testing

ASTM D4728-06 Standard test method for random vibration testing of shipping containers Method A

ASTM D5034 Standard test method for breaking strength and elongation of textile fabrics (grab test)

ASTM D5035 Standard test method for breaking force and elongation of textile fabrics (strip method)

ASTM D5276-98 Standard test method for drop test of loaded containers by free fall

ASTM D5946 Standard test method for corona-treated polymer films using water contact angle measurements
Standard test method for determining compressive resistance of shipping containers, components,
ASTM D642-00
and unit loads
ASTM D999-08 Standard methods for vibration testing of shipping containers Method A1

ASTM F1140 Standard test methods for internal pressurization failure resistance of unrestrained packages

ASTM F1342 Standard test method for protective clothing material resistance to puncture
Standard test method for microbial ranking of porous packaging materials (exposure chamber
ASTM F1608
method)
ASTM F1886-09 Standard test method for determining integrity of seals for medical packaging by visual inspection

ASTM F1929-98 Standard test method for detecting seal Leaks in porous medical packaging by dye penetration

ASTM F1980-07 Standard guide for accelerated aging of sterile barrier systems for medical devices
Standard test method for burst testing of flexible package seals using internal air pressurization
ASTM F2054
within restraining plates
Standard test method for detecting gross leaks in medical packaging by internal pressurization
ASTM F2096-04
(bubble test)
ASTM F2097 Standard guide for design and evaluation of primary flexible packaging for medical products
Standard test method for non-destructive detection of leaks in packaging which incorporates
ASTM F2228
porous barrier material by CO2 tracer gas method (porous materials to be covered)
Standard test method for nondestructive detection of leaks in packages by vacuum decay method
ASTM F2338
(porous materials to be covered)
Standard test method for using aerosol filtration for measuring the performance of porous
ASTM F2638-12
packaging materials as a surrogate microbial barrier
ASTM F3004 Standard test method for evaluation of seal quality and integrity using airborne ultrasound

ASTM F88/F88M-09 Standard test method for seal strength of flexible barrier materials

EN 20811 Determination of resistance of textile fabrics to water penetration—hydrostatic pressure test

EN 21974 Determination of tearing resistance of paper (Elmendorf method)

Paper and board—determination of tensile properties—Part 2: Constant rate of elongation method
EN ISO 1924 -2
(20 mm/min)

Appendix A1 Test methods and standards 65

A1 Test methods and standards
Table XIV. Test methods and standards (continued)

Standard/reference Description
European Food Contact EC Commission regulation (EU) N°10/2011 of 14 January 2011 on plastic materials and
Reg. 10/2011 articles intended to come into contact with food
European Pharmacopeia EP 3.1.3 Polyolefins

European Pharmacopeia EP 3.1.5 Polyethylene with additives for containers

ISO 2758 Paper—determination of bursting strength

Paper and board—determination of air permeance (medium range)—Part 5:
ISO 5636-5
Gurley method
ISO 9001 Quality management systems—requirements
Textiles—test methods for nonwovens—Part 10: Lint and other particles
ISO 9073-10
generation in the dry state
ISO 10993 Biological evaluation of medical devices
Packaging for terminally sterilized medical devices—Part 1: Materials, sterile
ISO 11607-1
barrier systems and packaging systems
Packaging for terminally sterilized medical devices—Part 2: Validation
ISO 11607-2
requirements for forming, sealing and assembly processes
Sterilization of medical devices—microbiological methods—Part 1: Determination
ISO 11737-1
of a population of microorganisms on products
ISO 14001 Environmental management
Packaging—complete, filled transport packages and unit loads—conditioning
ISO 2233:2000
for testing
ISTA 2A:2011 Simulation test for individual packaged-products less than 150 lbs

TAPPI T460 Air resistance of paper (Gurley method)

U.S. Food Contact 21 CFR 177.1520 Olefin polymers

U.S. Pharmacopeia USP <85> Bacterial endotoxins test

U.S. Pharmacopeia USP <88> Class VI Biological reactivity tests, in vivo

U.S. Pharmacopeia USP <661> Plastic packaging systems and their materials of construction

Appendix A1 Test methods and standards 66

A2 Methods for measuring properties

Aligned test methods and sampling plans for DuPont™

Tyvek® medical and pharmaceutical packaging styles

Appendix A2 Methods for measuring properties 67

A3 Guide to some common industry acronyms

AAMI Association for the Advancement of ISO International Organization for Standardization
Medical Instrumentation
ISTA International Safe Transit Association
AATCC American Association of Textile Chemists
JAMI Japan Association for the Advancement of
and Colorists
Medical Instrumentation
ANSI American National Standards Institute
JIS Japanese Industrial Standards
AORN Association of periOperative
JSA Japanese Standards Association
Registered Nurses
LRV Log reduction value
ASP Advanced Sterilization Products
MD Machine direction
ASQ American Society for Quality
MDD Medical Device Directive
ASTM American Society for Testing and Materials
MDM Medical device manufacturer
ATR Attenuated total reflectance
MDMA Medical Device
CAMDI China Association for Medical
Manufacturers Association
Device Industry
MEDEC Medical Devices Canada
CD Cross direction
MPTP Medical Packaging Transition Project
CEN European Committee for Standardization
MVTR Moisture vapor transmission rate
CFU Colony forming units
PDA Parenteral Drug Association
COF Coefficient of friction
pMax Maximum particle penetration
DIN Deutsches Institut für Normung (German
standards organization) RH Relative humidity

DPM Direct part marking SAC Standardization Administration of the

People’s Republic of China
DSC Differential scanning calorimetry
SAL Sterility assurance level
EDANA European Disposables and
Nonwovens Association SBA Sterile Barrier Association (formerly ESPA,
European Sterilization Packaging Association)
EDMA European Diagnostic
Manufacturers Association SBS Sterile barrier system

EN European norm SEM Scanning electron micrograph

EO Ethylene oxide SPM Sterile packaging manufacturer

EP European Pharmacopeia TAG Technical advisory group

FDA Food and Drug Administration TAPPI Technical Association of the

Pulp and Paper Industry
FFS Form-fill-seal
UDI Unique device identification
FICCI Federation of Indian Chambers of
Commerce and Industry USP United States Pharmacopeia

FTIR Fourier transform infrared spectroscopy UV Ultraviolet

HDPE High-density polyethylene VH202 Vaporized hydrogen peroxide

HPRC Healthcare Plastics Recycling Council VOCs Volatile organic compounds

IoPP Institute of Packaging Professionals

Appendix A3 Guide to some common industry acronyms 68

A4 References

European Committee for Standardization, EN ISO 11607- Kaller, N., Medical packaging study—the impact of
1:2017/Amd 1:2014 Packaging for terminally sterilized sterilization and transportation testing on the microbial
medical devices—Part 1: Requirements for materials, barrier of different materials, 2015, DuPont: Medical
sterile barrier systems and packaging systems, Packaging Knowledge Center.
Brussels, Geneva.

Larsen, C., Porous sterile barrier integrity testing: failure

International Organization for Standardization, ISO 11607- anomalies, 2006, MD&DI: mddionline.com
1/Amd 1:2014 Packaging for terminally sterilized medical
devices—Part 1: Requirements for materials, sterile barrier
systems and packaging systems, Geneva. DuPont™ Tyvek® Medical Packaging Transition Project
(MPTP) styles 1073B and 1059B compliance to ISO 11607-1:
2006 & EN ISO 11607-1:2009 as modified by Amd. 1: 2014,
European Committee for Standardization, EN ISO 11607- June 2017, DuPont.
2:2017/Amd 1:2014 Packaging for terminally sterilized
medical devices—Part 2: Validation requirements for
forming, sealing and assembly processes, Brussels. Tyvek™ for medical & pharmaceutical packaging
document library.

International Organization for Standardization, ISO 11607-

2:2006/Amd 1:2014 Packaging for terminally sterilized
medical devices—Part 2: Validation requirements for
forming, sealing and assembly processes, Geneva.

Kaller, N., Medical packaging study—reducing the risk of

failure through performance testing of packaging made
from various materials, 2014, DuPont: Medical Packaging
Knowledge Center.

Appendix A4 References 69
For more information about Tyvek® for medical and pharmaceutical packaging and to find out how we
can help you with packaging and regulatory compliance, visit us at medicalpackaging.dupont.com.
You can also find links to other resources in your country and information in other languages
at this website.
This document is not intended for use in the People’s Republic of China.

This Technical reference guide is applicable to Transition Tyvek ® 1073B and Transition Tyvek ® 1059B, as well as
Tyvek ® 2FS ™. In some cases, information based on data that was generated on Legacy Tyvek ® is presented. In those cases, this
distinction is clearly indicated. Transition Tyvek ® has been proven to be functionally equivalent to Legacy Tyvek ®. Legacy Tyvek ® is
either Tyvek ® 1073B or Tyvek ® 1059B produced on the original manufacturing lines. Transition Tyvek ® is either Tyvek ® 1073B or Tyvek ®
1059B produced on the newer manufacturing lines. This Document was originally published in October 2017 in addition to the
June 2017 Amended version, which is applicable to Legacy Tyvek ® 1073B, Legacy Tyvek ® 1059B and Tyvek ® 2FS ™.

This information is based upon technical data that DuPont believes to be reliable. It is subject to revision as additional knowledge
and experience are gained. DuPont makes no guarantee of results and assumes no obligation or liability in connection with
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