Electronic PDA Technical Reports

PDA Technical Report No. 79 (TR 79) Particulate Matter Control in Difficult to Inspect Parenterals (single user digital version)

PDA Technical Report No. 79, Particulate Matter Control in Difficult to Inspect Parenterals describes best practices for difficult to inspect parenteral (DIP) product lifecycle management, destructive testing, and trending to supplement portions of the guidance given in USP General Chapter<1790>: Visible Particulates in Injection.

In 2015, the PDA Task Force on Particulate Matter Control in Difficult to Inspect Parenterals initiated an industry survey on DIP products. literature, pharmacopeial references, and the collective expertise of Task Force contributors form the basis for the information provided in this technical report.

This Technical Report is intended to provide logical pathways to DIP product inspection and testing to support continual process improvement in the industry.

Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file 1.05 MB)

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Table of Contents:

Click here to download >>> Detailed Table of Contents
  1. Introduction
  2. Glossary
  3. Overview
  4. Expectations for DIP Inspection
  5. Inspection Approaches for DIP Products/Containers/Devices
  6. Defect Prevention: A Lifecycle Approach
  7. Conclusion
  8. References
  9. Appendix 1: Enhanced Methods for Revealing Visible Particles

Figures and Tables Index

Date of Publication: March 2018
ISBN Number: 9781945584022
Format: PDF File Size 540 KB
Number of Pages: 36