Glossary of equivalent standards
Committee representation
Introduction
1 Scope
2 Cited references
3 Definitions
4 Equipment requirements
4.1 Preconditioning
4.2 Sterilization chamber
4.3 Aeration/degassing
5 Process analysis
5.1 Overview
5.2 Frequency of EO analysis
5.3 EO analysis sampling location(s)
5.4 EO analysis accuracy
6 Process development
6.1 Overview
6.2 Use of biological indicators to develop the
sterilization process
6.3 Methods of determining lethality
6.3.1 Methods overview
6.3.2 Steps required by both methods
6.3.3 Method A: Survivor curve construction-Enumeration
of the BIs
6.3.4 Method B: Fraction negative
6.3.5 Sterilization cycle development process
troubleshooting
6.4 Sampling considerations for process development studies
6.5 Performance of Method A or B in a pilot or a production
chamber
6.5.1 Four ways that Method A or B may be performed
6.5.2 Establishing relationship between pilot
chamber and production chamber
6.6 Calculation of the sterilization cycle
6.7 Documentation of the process development
7 Validation
7.1 Commissioning (IQ/OQ)
7.2 Performance qualification (PQ)-Microbiological
7.3 Load configuration
7.4 Performance qualification-Physical
7.5 Revalidation
8 Routine processing
9 Product release
9.1 General
9.3 Electronic records and signatures
Annexes
A - Gas analysis issues
B - Sensor monitoring tables
C - Factors influencing accuracy and decisions
regarding the direct analysis of EO concentration