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Installation and Operational Qualification Protocol

This protocol established a baseline file of installation and operational data that can be used to maintain change control, determine operating setpoints, write operating procedures and aid in troubleshooting.

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TABLE OF CONTENTS

Cycle Development Protocol

This protocol is intended to provide a framework for developing the cycle parameters for the vaporized hydrogen peroxide biodecontamination system to be used in later protocols.

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TABLE OF CONTENTS

Performance Qualification Protocol

The goal of this protocol is to determine whether or not the vaporized hydrogen peroxide system is able to consistently biodecontaminate the exposed, internal surfaces of the isolator and the exposed, external surfaces of items placed within the isolator. This protocol establishes documented evidence that the vaporized hydrogen peroxide system can perform effectively and repeatedly based on the defined process parameters, methods and specifications.

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TABLE OF CONTENTS

False-Negative Analysis (Ingress Testing) Protocol

The objective of this protocol is to determine whether or not the vaporized hydrogen peroxide cycle generates a false-negative sterility testing result. The method used in biodecontaminating the outsides of product containers, media and supplies placed within the isolator must not kill potential viable microorganisms within the product container, media or supplies themselves that are to be sterility tested.

In this protocol, the amount of hydrogen peroxide penetration (if any) into the worst-case product sample container types following two back-to-back vaporized hydrogen peroxide biodecontamination cycles in the isolator will be determined via a chemical analysis study. Then the product sample configuration with the greatest amount of hydrogen peroxide penetration (worst-case) will be selected for biological analysis testing.

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TABLE OF CONTENTS

Growth Promotion Qualification of Environmental Monitoring Media Exposed to a Decontamination Cycle Protocol

The objective of this protocol is to determine whether or not the vaporized hydrogen peroxide cycle generates a false-negative environmental monitoring result. The method used in biodecontaminating the isolator (and the environmental monitoring media within the isolator) must not affect the environmental monitoring media’s ability to support growth of a wide range of microorganisms.

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TABLE OF CONTENTS