PDA Technical Report No. 76 (TR 76) Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging (single user digital version)
- Published
- Oct 2016
- ISBN
- 9780939459926
- Pages
- 59
- PDA Item Number
- 43529
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- Format
- PDF Single user
- Member Price
- $180.00
- Nonmember Price
- $325.00
- Government Price
- $180.00
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PDA's newly released Technical Report No. 76 (TR 76) Identification and Classification of Nonconformities in Elastomeric Closures and Aluminum Seals for Parenteral Packaging provides a building block for developing a comprehensive specification for elastomeric components and aluminum seals. It offers consistent and standardized quality criteria that can be used by pharmaceutical and medical device manufacturers for the visual inspection of incoming elastomeric components and aluminum seals, and by suppliers for outgoing inspection.
This report is not intended to establish mandatory standards for the classification and identification of elastomeric component and aluminum seal nonconformities. It is intended to be a single-source overview that complements existing guidelines and standards or documents listed in the reference section of this technical report.
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Format: PDF (1 file 13.5 MB)
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Table of Contents
Table of Contents:
Click here to download >>> Detailed Table of Contents- Introduction
- Glossary of Terms
- Elastomeric Components and Aluminum Seals Conformance Specification Development Process
- Identification and Classification of Visible Nonconformities
- Conclusion
- References
- Additional Reading
- Appendix A: Elastomeric Vial Stopper Nonconformity Lexicon
- Appendix B: Aluminum Seal Nonconformity Lexicon
Figures and Tables Index
About the Authors
Suzanne Seeley, Merck & Company, Inc., Co-Chair
Andrea Straka, West Pharmaceutical Services, Inc., Co-Chair
Roger Asselta, Genesis Packaging Technologies
Kristin Bartholomay, Baxalta US Inc
Douglas Cusato, BD Medical - Pharm Systems
Michael N. Eakins, Ph.D., Eakins & Associates
Brian Gallagher, Aptar Stelmi
Dana Morton Guazzo, Ph.D., RxPax LLC
Friedrich Haefele, Boehringer Ingelheim Pharma GmbH & Co. KG
Liz Herring, Datwyler
Lucia Ino, West Pharmaceutical Services, Inc.
Jennifer Johns, Pfizer Inc.
Patty H. Kiang, Ph.D., Kiang Consultant Services
Eric Lebossé de Lannoy, EMA Pharmaceuticals
Christopher Lau, Baxalta US Inc
James McFarland, Gerresheimer Glass Inc.
Sarvang Mishra, Sanofi
Munyee Pang, Merck & Company, Inc.
Kishan Rijal, Ph.D, GlaxoSmithKline
Wayland Rushing, Ph.D., Analytical Bio-Chemistry Laboratories, Inc.
Edward J. Smith, Ph.D., Packaging Science Resources, LLC
Dawn Watson, Merck & Company, Inc.
Kim White, BD Medical - Pharm Systems
Lisa Yoest, GlaxoSmithKline