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