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

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
  1. Introduction
  2. Glossary of Terms
  3. Elastomeric Components and Aluminum Seals Conformance Specification Development Process
  4. Identification and Classification of Visible Nonconformities
  5. Conclusion
  6. References
  7. Additional Reading
  8. Appendix A: Elastomeric Vial Stopper Nonconformity Lexicon
  9. Appendix B: Aluminum Seal Nonconformity Lexicon

Figures and Tables Index