Technical Information Report
Parametricreleaseforethyleneoxidesterilization
Parametricreleasefor ethyleneoxidesterilization
Approved 24 September 2001 byAssociation for the Advancement of Medical Instrumentation
Abstract:
This AAMI technical information report (TIR) provides guidance to augment information andrequirements for parametric release provided in ANSI/AAMI/ISO 11135:1994 Medtica/ devices- Validation and routine control of ethylene oxide (EO) sterilization. This TIR is intended to assistthose individuals using ANSI/AAMI/ISO 11135:1994 in understanding the steps necessary to develop and validate an ethylene oxide sterlization process that meets the standard'sappropriate actions where alternatives are given. The guidance in this TiR is limited to the requirements for parametric release. This TiR also provides guidance for choosing thesections of the standard that specifically address parametric release.
Keywords:
ethylene oxide parametric release sterilization validation
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Contents
Page
Glossary of equivalent standards . VCommittee representation.. vllIntroduction.1 Scope. .12 Cited references. 13 Definitions . 1Equipment requirements. 34.1 4.2 Preconditioning... Steriization chamber. 4 4Process analysis 4.3 Aeration/degassing.. 5 45 5.1 Overview... 55.2 5.3 EO analysis sampling location(s) Frequency of EO analysis. .5 .55.4 EO analysis accuracy- .5Process development... .56.1 6.2 Overview.. Use of biological indicators to develop the sterilization process 5 76.3 Methods of determining lethalit... 6.3.1 Methods overview. 7 76.3.2 6.3.3 Steps required by both methods.. Method A: Survivor curve construction-Enumeration of the Bls. 8 76.3.4 6.3.5 Method B: Fraction negative... Steriization cycle development process troubleshooting .9 86.4 6.5 Performance of Method A or B in a pilot or a production chamber 10 106.5.1 6.5.2 Four ways that Method A or B may be performed. Establishing relationship between pilot chamber and production chamber.. 10 116.6 6.7 Calculation of the sterlization cycle Documentation of the process development . 12 12T Validation . 127.1 7.2 Performance qualification (PQ)-Microbiological. Commissioning (IQ/OQ) . 12 127.3 7.4 Performance qualification-Physical. Load configuration... 13 137.5 Revalidation.. 138 Routine processing - 149 Product release.... .. 149.1 9.2 Electronic records and signatures.. General.. Writen procedures. 14 149.3 14
Annexes
Gas analysis issues BSensor monitoring tables A 15CFactors influencing accuracy and decisions regarding the direct analysis of EO concentration... 20 17
Tables
Site selection of Bl sample. 10B.1 Sterilization. 17B.2 Preconditioning and/or conditioning. 18B.3 Sterilization.. 19Figure
