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Technical Tip: Comparison of Aami Methods For Setting of Minimum Sterilization Dose With Irradiation

This document compares methods for setting minimum sterilization doses using gamma irradiation according to AAMI standards. It provides a table contrasting Method 1, Methods 2A and 2B, and VDmax methods. Key differences include the maximum bioburden allowed, number of samples tested, sterilization and verification doses determined, and whether single incremental processing is permitted. The VDmax methods allow setting fixed sterilization doses between 15-35 kGy depending on the maximum expected bioburden for a product.

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Rakesh
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140 views3 pages

Technical Tip: Comparison of Aami Methods For Setting of Minimum Sterilization Dose With Irradiation

This document compares methods for setting minimum sterilization doses using gamma irradiation according to AAMI standards. It provides a table contrasting Method 1, Methods 2A and 2B, and VDmax methods. Key differences include the maximum bioburden allowed, number of samples tested, sterilization and verification doses determined, and whether single incremental processing is permitted. The VDmax methods allow setting fixed sterilization doses between 15-35 kGy depending on the maximum expected bioburden for a product.

Uploaded by

Rakesh
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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TECHNICAL TIP

COMPARISON OF AAMI METHODS FOR SETTING OF MINIMUM


S T E R I L I Z AT I O N D O S E W I T H I R R A D I AT I O N

The Association for the Advancement of Medical Instrumentation References


(AAMI) generates numerous standards and guidelines used by
1. ANSI/AAMI/ISO 11137-1:2006. Sterilization of health
professionals in the healthcare industry. Occasionally, the AAMI
care products – Radiation-Part 1: Requirements for
Standards board will provide additional guidance to specific
development, validation, and routine control of a
standards in the form of a Technical Information Report (TIR).
sterilization process for medical devices.
These TIRs reflect common industry practices that evolve from
an accumulated process knowledge base. 2. ANSI/AAMI/ISO 11137-2 :2006. Sterilization of health care
products – Radiation-Part 2: Establishing the sterilization
In the last few years many changes have occurred to the
dose.
guidance documents we have all followed to set minimum
sterilization doses. With the completion of ANSI/AAMI/ISO 3. ANSI/AAMI/ISO 11137-3:2006. Sterilization of health care
11137:2006 and the addition of AAMI TIR 33, many options products – Radiation-Part 3: Guidance on dosimetric
were placed in the hands of the healthcare industry. Significant aspects.
changes, such as bringing VDmax25 into an ISO document, the
4. AAMI TIR 33:2005. Sterilization of healthcare products-
additional of a VDmax15 option, and incorporation of single lot
Radiation-Substantiation of a selected sterilization dose-
validation for Method 1, have eliminated or reduced the need to
Method VDmax.
use older AAMI or AAMI/ISO documents such as TIR 27, 15844
and 13409 . These changes have also made the familiarity with
the current ANSI/AAMI/ISO documents even more critical to the
needs of the healthcare industry.
While this document is not intended to be an exhaustive
comparison of old versus new guidelines, we wanted to bring
together in a chart format a comparison of the methods
available as starting point when preparing to review these
documents for the first time as they apply to your specific
product needs or requirements. This TechTip will look at dose
setting, while a companion document will look at dose audits in
the same format.
Please see page two of this TechTip for a comparison of
gamma dose determination methods.

F O R M O R E I N F O R M AT I O N
STERIS Applied Sterilization Technologies
Web: steris-ast.com // Email: ast_info@steris.com
(EMEAA) +44 (0) 8456 88 99 70
(Americas) 877.783.7479

TechTip #23 | Rev 1, 03/18


TECHNICAL TIP

COMPARISON OF AAMI METHODS FOR SETTING OF MINIMUM


S T E R I L I Z AT I O N D O S E W I T H I R R A D I AT I O N

G A M M A D O S E D E T E R M I N AT I O N M E T H O D C O M PA R I S O N

Method Method 1 Method 2A Method 2B VDmax15 VDmax17.5 VDmax20.0

Max CFU 1,000,000 N/A N/A 1.5 9 45

Verification 1.3 kGy (10-2) 2 (10-2) 1 (10-2) 0.5* (10-1) 0.6* (10-1) 0.7* (10-1)

Lowest Possible Dose 0.1-0.9 CFU:


11.0 kGy
Sterilization (10-6) 8 kGy 10 kGy 15 kGy 17.5 kGy 20 kGy
>1 CFU:
14.2 kGy

Bioburden 3 lots/10 each None None 3 lots/10 each 3 lots/10 each 3 lots/10 each

Number of Samples
640 (3 lots, 20 580 (3 lots, 20
Sterility 100 10 10 10
each, per dose) each, per dose)

2 kGy 1 kGy
Verification Dose Per Table Incremental: 9 Incremental: 8 Per Table Per Table Per Table
Dose doses doses
Determination Method
Sterilization Dose
Per Table Calculated Calculated 15 kGy 17.5 kGy 20 kGy
Items

Sterility Passing Criteria ≤ 2 positive ≤ 2 positive ≤ 2 positive ≤ 1 positive ≤ 1 positive ≤ 1 positive

SIP Allowed Yes Yes No No if bioburden ≥1 if bioburden ≥1

F O R M O R E I N F O R M AT I O N
STERIS Applied Sterilization Technologies
Web: steris-ast.com // Email: ast_info@steris.com
(EMEAA) +44 (0) 8456 88 99 70
(Americas) 877.783.7479

TechTip #23 | Rev 1, 03/18


TECHNICAL TIP

COMPARISON OF AAMI METHODS FOR SETTING OF MINIMUM


S T E R I L I Z AT I O N D O S E W I T H I R R A D I AT I O N

G A M M A D O S E D E T E R M I N AT I O N M E T H O D C O M PA R I S O N

Method VDmax22.5 VDmax25.0 VDmax27.5 VDmax30.0 VDmax32.5 VDmax35.0

Max CFU 220 1000 5000 23,000 100,000 440,000

Verification 0.8* (10-1) 0.8* (10-1) 4.6**(10-1) 0.5* (10-1) 5.4** (10-1) 5.8* (10-1)
Lowest Possible Dose
Sterilization (10-6) 22.5 kGy 25 kGy 27.5 kGy 30 kGy 32.5 kGy 32.5 kGy

Bioburden 3 lots/10 each 3 lots/10 each 3 lots/10 each 3 lots/10 each 3 lots/10 each 3 lots/10 each
Number of Samples
Sterility 10 10 10 10 10 10

Verification Dose Per Table Per Table Per Table Per Table Per Table Per Table
Dose
Determination Method
Sterilization Dose
22.5 kGy 25 kGy 27.5 kGy 30 kGy 32.5 kGy 35 kGy
Items

Sterility Passing Criteria ≤ 1 positive ≤ 1 positive ≤ 1 positive ≤ 1 positive ≤ 1 positive ≤ 1 positive

if bioburden
SIP Allowed if bioburden ≥1 if bioburden ≥1 if bioburden ≥1 if bioburden ≥1 if bioburden ≥1
≥1

F O R M O R E I N F O R M AT I O N
STERIS Applied Sterilization Technologies
Web: steris-ast.com // Email: ast_info@steris.com
(EMEAA) +44 (0) 8456 88 99 70
(Americas) 877.783.7479

TechTip #23 | Rev 1, 03/18

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