PDA Technical Report No. 69 (TR 69) Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations (single user digital version)
- Published
- Jun 2015
- ISBN
- 9780939459766
- Pages
- 73
- PDA Item Number
- 43521
Premium Members: to claim your annual free technical document download, email membership@pda.org and indicate the document you wish to claim.
- Format
- PDF Single user
- Member Price
- $180.00
- Nonmember Price
- $325.00
- Government Price
- $180.00
Please sign in or become a member to purchase items from the PDA bookstore.
PDA Technical Report No. 69, (TR 69) Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations presents the current scientific understanding of the causes of and control strategies for bioburden in pharmaceutical production systems, with a special emphasis on biofilms in fluid-handling systems. It encompasses pharmaceutical and biopharmaceutical manufacturing processes, but does not include the final aseptic and terminal sterilization fill-finish operations.
Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file 855 KB)
Click here to order paper ship version (Item no. 01069).
*To purchase licensing, please contact PDA at info@pda.org.
Table of Contents
Table of Contents:
Click here to download >>> Detailed Table of Contents- Introduction
- Glossary of Terms
- Overview of Bioburden and Biofilms
- Design, Control, and Prevention Considerations
- Bioburden and Biofilm Detection and Characterization
- Investigation and Remediation
- Contamination Scenarios
- Appendix I: Bioprocess Unit Operations and Typical Process Controls and Detection
- Appendix II: Typical Bacterial Response Limits for Bioprocessing
- References
Figures and Tables Index