DOC 3

MICROBIOLOGICALLY SAFE ASEPTIC PACKING

OF FOOD PRODUCTS
January 1993
European Hygienic Engineering and Design Group
EHEDG Secretariat
Ms. Susanne Flenner
Lyoner Str. 18
60528 Frankfurt, Germany

Tel.: +49-69-66 03-12 17

Fax: +49-69-66 03-22 17
E-Mail: susanne.flenner@ehedg.org
Website: www.ehedg.org

Developed with the support of the European Commission and in cooperation with 3-A and NSF
International.

THE ENGLISH VERSION OF THIS EHEDG DOCUMENT IS THE OFFICIAL VERSION. THE EUROPEAN
COMMISSION SUPPORTS THE DEVELOPMENT OF THE EHEDG GUIDELINES. THE RESPONSIBILITY FOR THE
PREPARATION, DEVELOPMENT AND ISSUANCE OF SUCH GUIDELINES LIES WITH EHEDG. DUE TO THE
TECHNICAL AND GENERAL NATURE OF THE GUIDELINES, NEITHER THE EC NOR EHEDG MAY ASSUME ANY
LIABILITY RESULTING FORM THE INTERPRETATION, APPLICATION OR USE OF SUCH GUIDELINES.

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Contents Page

1 Definitions ..............................................................................................................................................6
2 Responsibility ........................................................................................................................................6
3 Microbial contamination rates from various sources........................................................................7
4 Difference in the risks of infection in aseptic processing ................................................................7
5 Requirements for equipment used in aseptic packing......................................................................8
5.1 Materials and surface finish .................................................................................................................8
5.2 Equipment for the filling and dosing of product................................................................................8
5.3 The interior of the packing machine....................................................................................................8
6 Storage, handling and transport of packing materials......................................................................9
7 Decontamination of packing material ...............................................................................................10
8 Sterile air systems...............................................................................................................................10
9 Pack integrity .......................................................................................................................................11
10 Monitoring ............................................................................................................................................12
11 Operation manual ................................................................................................................................12
12 Validation .............................................................................................................................................12
13 Conclusions .........................................................................................................................................13
14 References ...........................................................................................................................................13
Appendix A........................................................................................................................................................14
A.1 General .................................................................................................................................................14
A.2 Specific with respect to the hygienic characteristics of food processing equipment.................14

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 MICROBIOLOGICALLY SAFE ASEPTIC PACKING
OF FOOD PRODUCTS*

M.A. Mostert **(1), G. Buteux (2), P.C. Harvey (3), W. Hugelsdorfer (4), P. Melbin (5), J. Nassauer (6),
G. Reinecke (7), W. Weber (8), B. Wilke (9)

* Prepared by the Subgroup Packing Machines of the European Hygienic Engineering and Design Group
(EHEDG), January 1993.

** Chairman

(1) Van den Bergh en Jurgens, P.O.B. 160, NL-3000 AD Rotterdam, The Netherlands.

(2) Serac, P.O.B. 120, F-72405 La ferte-Bernard Cedex, France.

(3) RHM, Lincoln Road, HP12 3QR High Wycombe, Bucks, Great Britain.

(4) Alpura Koreco Ltd., P.O.B. 12, CH-3610 Konolfingen, Switzerland.

(5) AB Tetra Pak, Ruben Rausings gata, S-221 86 Lund, Sweden.

(6) Kraft General Foods Europe R&D, P.O.B. 83 05 50, D-8000 München 83, Germany.

(7) Hamba Verpackungsmaschinen, P.O.B. 66 80, D-Neunkirchen-Saar-Wellesweiler, Germany.

(8) Gasti Verpackungsmaschinen GmbH, P.O.B. 100264 , D-7170 Schwäbisch-Hall, Germany.

(9) Robert Bosch GmbH, P.O.B. 11 27, D-7050 Waiblingen, Germany.

The production of this EHEDG Guideline was supported by the European Commission under the Quality of
Life Programme, Project HYFOMA (QLK1-CT-2000-01359).

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Summary

This document discusses issues which must be considered when aseptic packing of food is intended. It
stresses that it is of prime importance to decide which microorganisms are relevant. It must be decided which
contamination rates with such microorganisms are acceptably low.

Sources of contamination must be identified and subsequently quantified.

Based on the results, measures to reduce the contamination rate to below the acceptable level must be
devised.

All packing machine components that may come in contact with the product to be packed should be of
hygienic design, allowing adequate cleaning and decontamination. The construction should prevent
unacceptable recontamination of decontaminated packing material or product.

Critical parameters (including seal integrity) must be monitored.

During commissioning, the efficiency of the aseptic packing operation should be validated.

If a new product is to be packed, the procedure to achieve an acceptably low rate of contamination must be
repeated in its entirety.

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Introduction
The European Hygienic Engineering and Design Group (EHEDG) publishes guidelines on microbiologically safe
manufacture of food. Guidelines on continuous pasteurisation1 and testing of the cleanability of equipment2 have been
published recently. This article, prepared by the EHEDG subgroup Packing Machines, deals with microbiologically safe
aseptic packing of sterilized food products. It has been approved by the EHEDG. It is the intention to prepare separate
guidelines on non-aseptic packing of food.

In theory, aseptic packing is extremely simple: a product, free from undesired microorganisms, is packed in
packing material that is also free from undesired microorganisms; during this operation, microorganisms are
denied access to the product or packing material. However, in practice, aseptic packing is a rather demanding
process.

Methods of freeing the product from microorganisms, decontaminating packing material, and sterilizing air in
contact with product and packing material are well understood. Other potential sources of microbial
contamination, however, often are not recognized.

Firstly, it is essential to decide which microorganisms are relevant (see Appendix 1 for definitions). It is also
important, yet relatively unusual, to quantify the risks of contamination with microorganisms from the various
sources. It is even more uncommon is to quantify the target - to determine the maximum level of relevant
microorganisms acceptable in the packed product, or, in other words, the maximum number of packs
contaminated with potentially harmful microorganisms. Yet this is necessary to reduce the risk to the required
level necessary, as it is not realistically possible to reduce the risk to zero.

This paper discusses a quantitative approach to the aseptic packing of food products to achieve an acceptably
low risk of contamination. It also summarizes the EHEDG guidelines on design, operation and maintenance of
aseptic packing machines.

1 Definitions
The EHEDG definitions (see appendix A) are used throughout this publication. In addition one definition,
especially used for packing machines is used:

Product contact surface

All surfaces of the machine that intentionally or unintentionally come in contact with the product, or from which
product, condensate may drain, drop, or be drawn into the product or container including surfaces (e.g.
unsterilized packs) that may indirectly Cross contaminate product contact surfaces or containers.

2 Responsibility

The producer is always responsible for the product packed and, hence, the producer must define the
acceptable risk, possibility in consultation with interested parties, such as public health authorities and
customers. The minimum requirements for the packing machine depend on this target level.

As requirements may differ between products, it is also essential that requirements are specified again if other
products are to be packed on an aseptic packing machine. If needed, packing machine settings must be
changed.

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3 Microbial contamination rates from various sources

The microbial contamination rate (CR) is defined as the number of contaminated packs divided by the total
number of packs filled:

CR = number o f contaminated packs

total number of packs filled

The CR of the packed product (provided that the individual rates are much smaller than 1) is the sum of the
individual CRs contributed by a number of sources:

⎯ packing material (CRpack);

⎯ air (CRair);

⎯ product adhering to the filling nozzle (CRnozzle);

⎯ product (CRproduct);

⎯ pack integrity (CRintegrity);

⎯ other sources, such as the product contact surfaces in the open-pack area (CRother).

The measured total value of CR should be less than or equal to the acceptable contamination rate for the
packed product. Hence, if the acceptable contamination rate is x, then

CR ≤ X or,

CRpack + CRair + CRnozzle + CRproduct + CRintegrity + CRother ≤ x.

Example:

If all contributions except packing material together contribute a contamination rate 0.9 x, then the packing
material should contribute CRpack ≤ 0.1 x. If, without decontamination treatment, it would contribute, say,
1000 x, then to ensure that its contribution is acceptable, the decontamination treatment must result in a
reduction factor (R) of at least:

R ≥ CR before treatment = 1000 x

acceptable contribution 0.1 x

thus R ≥ 104.

A comprehensive review of this approach is provided in Ref. 3.

4 Difference in the risks of infection in aseptic processing

In process lines, with or without a buffer tank, there is usually a continuous flow of product, so that a single
microorganism able to grow in the product may affect the entire batch. On the other hand, after the product
has been divided into individual, physically separated portions, a microbiological hazard caused by a single
microorganism will be confined.

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Example:

If a pasteurized product in a stirred, 1000-litre buffer tank is contaminated with a single microorganism, which
is allowed to multiply (suitable temperature and storage time), the number may easily increase to 106 - an
average concentration of 1 micro-organism/gram.

Consequently, depending on the intensity of mixing, this may result in every pack filled being infected and
spoiled. However, if the same microorganism infects the product during packing, even if it multiplies to a level
of 109 microorganisms/g (i.e. 109 times as high as assumed above), it cannot infect any other pack; only one
pack will be spoiled.

5 Requirements for equipment used in aseptic packing

5.1 Materials and surface finish

All product contact surfaces must be resistant to the cleaning agents and temperatures used. The supplier
must list any materials used that are not resistant to commonly used cleaning and decontamination chemicals
or conditions.

The surface roughness, Ra (Ref. 4), of the product contact side must be less than 0.8 µm.

5.2 Equipment for the filling and dosing of product

Aseptic packing machines must be equipped with aseptic fillers. This means easily cleanable (preferably in-
place), suitable for decontamination (after re-assembly) and bacteria-tight.

To ensure that the equipment is easily cleanable in-place, it should have no dead spaces, crevices, and no
areas of low velocity of the cleaning liquid.

To allow adequate decontamination, all product contact surfaces should reach the conditions as specified by
the procedure (temperature, time, humidity, concentration).

The equipment must be bacteria-tight to prevent the penetration of microorganisms from the non-product side
to the product side. To this end, moving-shaft passages between the "sterile" and "unsterile" areas must be
avoided, unless they are sealed against the ingress of microorganisms. This may be achieved by using
diaphragms, bellows and double seals with a flush in between. The flush should remove or destroy
microorganisms so that they do not enter the product side. The fluid used in the flush should be nontoxic.

In addition to the requirements listed under 6.1 above, all product contact surfaces must be resistant to the
product under the process conditions (temperature, pressures). In principle stainless steel (AISI series 304 to
316 or better) should be used. Non-metallic materials should comply with the FDA5 or the BGA6 regulations.
Some materials have so little resilience that they may creep under process or cleaning conditions. These
should be avoided or used with great care, as their shape may deform permanently under load. More detailed
guidelines on the selection of materials for food contact applications will appear in a forthcoming EHEDG
report7.

5.3 The interior of the packing machine

To reduce the risk of contamination with microorganisms from the immediate environment of the exposed
product, the interior of the machine including all parts that may come into contact with product, air or
condensate, should be cleaned sufficiently.

Preferably, the design should allow cleaning in-place (CIP) of the interior. If this is not possible, each part of
the machine interior must be accessible for cleaning by hand, with or without dismantling. Decontamination
must take place after reassembly.

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Exposure of product
The risk of infection can be minimized by minimizing the time the product is exposed to the surrounding air in
an Open container; thus the container should be sealed as soon as possible after filling. During transfer from
the filling station to the sealing station, the product must be protected against re-contamination through the air.
The air may have to be decontaminated, and the air pressure should be highest in the exposed product area.

Cleaning
To limit difficulties with cleaning of the product contact area, any moving parts of the machine should, as far
as possible, be situated outside the product contact area. If CIP is applied, the moving parts must be activated
during cleaning.

The cleaning procedure selected should take into account the type of product packed and, hence, the type of
soil in the machine.

The development of methods to test the cleanability of the interior of the packing machines is strongly
recommended.

Decontamination
Decontamination may be achieved by hot water, steam, chemical solutions or gaseous antimicrobial agents.

Decontamination may fail to be effective due to excess water residues, which may cause two major problems:

⎯ dilution of the chemical used for decontamination;

⎯ and multiplication of micro-organisms when the machine is standing idle (e.g. overnight or over the
weekend) leading to insufficient inactivation of the large numbers of microorganisms produced.

Therefore, the equipment should be drainable, so that no water (or other liquid) remains anywhere in the
interior of the aseptic area of the machine at the end of the cleaning procedure.

6 Storage, handling and transport of packing materials

Generally, the microbial load of packing materials for aseptic filling is low immediately after manufacture. This
is partly due to the heat applied during extrusion of plastic materials, for the drying varnishes, or to melt glass.

Contamination takes place after manufacture, and should be controlled by adequate measures. Possible
sources of infection are:

⎯ dust or other matter;

⎯ humidity (moisture in the presence of -even traces- of nutrients, will allow multiplication of micro-
organisms);

⎯ people;

⎯ insects or other pests.

To limit re-infection, special precautions may be needed, such as:

⎯ protection (by the packing material manufacturer) of all packing material by wrapping in foil, within a
box, and with minimum use of cardboard;

⎯ removal of dust (e.g. by ionised air or filters in the ventilation system);

⎯ ensuring that the product contact surface is touched by clean (and possibly protected) hands only,
and not be by contaminated equipment or materials, after removal of the protective wrapping;

⎯ ensuring that areas where packing material is handled are always kept dry.

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Suppliers of the packing material must provide instructions for use of storage and handling of the packing
material.

The tightness, and therefore the sterility, of the filled containers can be influenced by mechanical damage or
deforination during the transport and handling of packing material. Precautions must be taken to prevent such
faults, which may be caused by:

⎯ mechanical damage (e.g. by fork lifts, palletisers, or from stacking pallets too high etc.);

⎯ changes of the material properties due to inadequate storage conditions (excessive temperature,
humidity, light, etc.);

⎯ deformation in the filling machine (e.g. due to excessive hat, mechanical or chemical stress etc.).

Mechanical damage can be detected visually and by applying adequate controls on packing material (see also
DIN 16901 8).

7 Decontamination of packing material

The microbiological load of the packing material (tubs, lids, bottles etc.) must be monitored, and has to be low
enough to prevent exceeding the acceptable rate of contamination. Usually, the packing material must be
decontaminated to achieve this.

Examples of decontamination methods are:

⎯ hydrogen peroxide;

⎯ heat;

⎯ ultraviolet light;

⎯ other chemical methods,

⎯ or combinations of the above.

The manufacturer of the packing machine should specify conditions for obtaining specified decontamination
rates (reduction factors), and provide evidence that they are effective. Dust protects microorganisms and
hence should not be present in the containers.

8 Sterile air systems

The microbiological quality of the air supplied must be tested and made to comply with minimum requirements
to prevent CRair from being too high. This is the responsibility of the user of the equipment. The concentration
of micro-organisms in air may be reduced by:

incineration;

filtration - with once-only sterilisable filters;

with repeatedly sterilisable filters.

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Incineration
Air is sucked from outside or from the superstructure of a machine into the superheater, where it is heated
(typically to 400°C), then cooled down to a temperature suitable to the individual packing system and fed back
to the packing machine.

Filtration
Filters must be sterilisable (once-only or repeatably). Where once-only sterilisable filters are used, care must
be taken that the flow of air through the filters is continuously, even when the packing machine is not in use.

Sterilisation of the filters may be achieved by means of:

⎯ chemicals (low pressure filters and filter cartridges);

⎯ steam (filter cartridges only).

Maintenance
Preventive maintenance of the filter system is very important. Filters should be replaced before their
performance becomes inadequate. The performance of the filters during use may be checked by measuring

⎯ the pressure drop over the filter;

⎯ the flow at constant pressure;

⎯ the level of particles in the air.

9 Pack integrity

Most aseptic packages are closed by heat-sealing, ultrasonic sealing or glue. Some containers are also
closed by conventional methods (e.g. folded seams, snap-on lids, twist-off caps, screw caps, etc.).

High reliability of closures is an essential precondition for a low contamination rate.

Sealing defects may arise from many factors, not only as a result of the sealing operation itself. For this
reason the following recommendations are given:

⎯ the construction of the closure of container and lid should be such that the required seal can easily
be obtained;

⎯ temperature and pressure should be properly distributed over the sealing surfaces;

⎯ all parameters for the sealing process, such as sealing time, pressure and temperature, have to be
set with a safety margin and must be adequately controlled (monitored and alarmed for out-of-control
situations);

⎯ if several packages are sealed in the Same operation, the packages must be uniformly sealed;

⎯ contamination of the sealing surfaces by product or other material (e.g. from splashing, dripping or
foaming) should be avoided;

⎯ the seal must be accurately located, especially in the case of thermoform/fill/seal-machines, where
local deviations may occur between the forming station and the sealing station.

Integrity testing (e.g. biotesting) of filled packages is highly desirable. The further development of on-line
monitoring of seals and closures is strongly recommended.

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10 Monitoring

Essential parameters should be monitored and properly controlled. If safety limits are exceeded, the packing
process must be stopped. Various parameters may have to be monitored, depending on the type of aseptic
packing machine used.

Process Parameters to be monitored

Decontamination of machine:
All methods Temperature; time.
⎯ Dry heat, hot water or steam Humidity.

⎯ Chemicals in liquid form Concentration.

⎯ Gaseous chemicals Concentration; humidity.

⎯ Decontamination of the process Temperature; time

line, dosing pump and filling nozzle Pressure.

Decontamination of packing materials:

⎯ Chemicals Temperature; time; quantity dosed;
Concentration; residual amount.

⎯ UV radiation Energy; time.

Decontamination of air:
⎯ Incineration of air Temperature; flow rate

⎯ Filters Pressure drop

Packing: Sealing time, temperature, pressure; positioning (see

10 above); pack seal integrity.

Depending on the machine design, additional critical parameters may need to be monitored and controlled.

11 Operation manual

The operation or instruction manual, to be provided by the packing machine manufacturer, must include
information on resistance of materials used against cleaning and decontamination chemicals and conditions. It
must also give recommendations on effective cleaning and decontamination procedures, and clear
instructions on preventive maintenance.

12 Validation

It is essential that critical parameters are carefully controlled and cannot be changed accidentally in any way
without being noticed. Particularly in the case of products in which pathogenic or toxigenic rnicroorganisms
are able to grow, it is essential that the complete process is carefully validated before cornmercial production
is started, to minimize the chance of errors in design or procedures not being promptly recognised.

Detailed procedures to achieve hygienic food manufacturing systems will be given in a separate forthcoming
EHEDG report9; see also Ref. 10.

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13 Conclusions

It is of prime importance for those involved with aseptic food packing to decide which microorganisms are
relevant to the microbiological safety of the particular food product concerned. Acceptably low contamination
rates must be determined for each relevant microorganism, and sources of contamination must be identified
and quantified. Based on the results, measure to reduce the contamination rate to below the maximum
acceptable level must be devised.

All packing machine components that may come in contact with the product should be of hygienic design,
allowing adequate cleaning and decontamination. The construction should prevent unacceptable
recontamination of decontaminated packing material or product. The efficiency of the aseptic packing
operation should be validated during the commissioning of new equipment, and critical parameters (including
seal integrity) must be monitored during use. Finally, if existing equipment is to be used for packing of a new
food product, the procedure to achieve an acceptably low rate of contamination must be repeated in its
entirety.

14 References
1) Microbiologically safe continuous pasteurisation of liquid food, EHEDG guidelines, 1992.

2) A method for the assessment of in-place cleanability of food processing equipment, EHEDG
guidelindes, 1992.

3) Cerf 0. & Brissenden C>H. 1981. Aseptic Packaging, International. Dairy Federation
Document 133, 93-104.

4) ISO Standard 468, 1984.

5) USA code of federal regulations of the FDA (CFR 21, parts 1870 to 199), latest edition.

6) KUNSTSTOFFE IM LEBENSMITTELVERKEHR
Empfehlungen des Bundesinstitutes für gesundheitlichen Verbraucherschutz und
Veterinärmedizin (Bis 30. Juni 1994: Empfehlungen des Bundesgesundheitsamtes).
Textsammlung auf Grund der amtlichen Bekanntmachungen. Begründet von Prof. Dr. Rudi
Franck, Herausgegeben von Dr. Helmut Wieczorek. 45. Lieferung, Stand: Dezember 1995. Carl
Heymanns Verlag KG, Köln, Berlin, Bonn, München.

7) EHEDG Guidelines on selection of materials for food contact application, in preparation

8) DIN 16901 : Kunststoff-Formteile - Toleranzen und Abnahmebedingungen für Längenmaße.

November 1982

9) Procedures to achieve hygienic food manufacturing systems, EHEDG Guideline in preparation

10) Validation of aseptic processing and packaging, D.T. Bernard, A. Gavin III, V.N. Scott, B.D.
Shafer, K.E. Stevenson, J.A. Unverferth and D.I. Chandarana, Food Technology, December 1990,
119 – 122.

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 Appendix A

European Hygienic Engineering and Design Group

Definitions of expressions relevant to hygienic processing and plant design

30th May 1991

A.1 General

Relevant Microorganisms1
Microorganisms able to contaminate, multiply or survive in the product and harmful to the consumer or product
quality.

Soil
Any undesired matter including product residues whether containing microorganisms or not.

Cleaning
The removal of soil.

Destruction of microorganisms
Irreversible physical or chemical damage to microorganisms to prevent them from surviving and multiplying.

Thermal destruction
Destruction of microorganisms using heat which may or may not be in combination with water or steam.

Chemical destruction
Destruction of microorganisms using biocidal chemical(s).

Sterilization
The removal or destruction of microorganisms, including all relevant bacterial spores.

Pasteurization2
Thermal destruction of vegetative microorganisms i.e. excluding thermoresistant bacterial spores.

A.2 Specific with respect to the hygienic characteristics of food processing

equipment

Cleanability
The suitability to be freed from soil.

Comparative cleanability
The cleanability of equipment relative to a reference.

In-place cleanability
The suitability to be cleaned without dismantling.

Steam sterilizability3
The suitability of clean equipment to be freed from viable microorganisms including relevant bacterial spores
(i.e. sterilized) by a treatment with saturated steam at 120°C for 30 minutes.

Hot water sterilizability3

The suitability of clean equipment to be freed from viable microorganisms including relevant bacterial spores
(i.e. sterilized) by a treatment with potable water at 120°C for 30 minutes.

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Pasteurizability3
The suitability of clean equipment to be freed from viable microorganisms with the exception of
thermoresistant bacterial spores by a treatment with hot potable water of up to 95°C for 20 minutes (i.e.
pasteurized).

Microbial impermeability
The ability of equipment to prevent the ingress of bacteria, yeasts and moulds from the outside (environment)
to the inside (the product area).

Hygienic equipment class I4

Equipment that can be cleaned in-place and can be freed from relevant microorganisms without any
dismantling.

Hygienic equipment class II4

Equipment that is cleanable after dismantling and can be freed from relevant microorganisms5 AFTER re-
assernbly.

Aseptic equipment
Hygienic equipment that in addition is impermeable to microorganisms.
1
Throughout this document the term microorganisms includes bacteria, yeasts and moulds
2
In the dairy industry pasteurization usually means the destruction of pathogenic and some spoilage
microorganisms.
3
Alternative conditions can be used depending on local circumstances.
4
If equipment does not comply with the definitions, this will be due to sharp Corners, narrow orifices,
crevices, hollow bodies, dead legs, etc. Such equipment can still be used to produce microbiologically safe
products, provided that the dismantling and after-cleaning inspection is totally carried out before each
production period and the equipment is not soiled again during re-assembly. Furthermore, it may be
necessary to use more- aggressive decontamination methods and to increase the frequency of cleaning.
The disadvantages is that less productive and, therefore, more costly procedures are required. Future aim
should be to redesign such equipment.
5
By e.g. steam or hot water sterilization, or pasteurization, in accordance with the definitions for sterilizability
and pasteurizability.

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