PDA Technical Report 34, (TR 34) Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products (paper ship version)
- Published
- Sep 2001
- Pages
- 25
- PDA Item Number
- 01034
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- Format
- Book
- Member Price
- $50.00
- Nonmember Price
- $100.00
- Government Price
- $50.00
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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.
Click here to order digital version (Item no. 43239)
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