PDA Technical Report No. 34, (TR 34) Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products (single user digital version)

Sep 2001
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This Technical Report was prepared by PDA Isolation Technology Task Force Members.

The report addresses essential user requirements for the application of isolator technology to a broad range of manufacturing, development and testing applications in the health care product manufacturing industry. It covers not only product sterility assurance, but also the use of isolators for the containment of hazardous materials.

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Table of Contents

Table of Contents:

1. Introduction
2. Types of Isolators
3. Isolator Design and General Construction
4. Functional Specifications for Isolators
5. Facility Requirements
6. User Requirement Specifications (URS)
7. Re-Qualification Testing
8. Conclusion
Appendix A: Glossary
Appendix B: Ljungqvist/Reinmuller (L-R) Method
Appendix C: Test Methods, Pressure Drop Test
Appendix D: Isolators and Sterility Assurance
References and Text Notes