Over the years, PDA expert task forces have developed several technical reports on moist and dry heat sterilization processes. In addition, experts in the PDA community of published several articles on these topics and alternative sterilization methods in the PDA Journal of Pharmaceutical Science and Technology. Now you can own all of them in one file.
This volume is a convenient and powerful reference for individuals working with sterilization processes for pharmaceutical products. This compilation will be an invaluable guide for you to navigate the scientific and regulatory aspects of traditional and alternative sterilization methods.
Available to download
Format: PDF (1 file 45.9 MB)
**This is a large file. The download times will depend on your internet connection speed.
Table of Contents:
Click here to download >>> Detailed Table of Contents.Technical Report 1, Revised 2007, Validation of Moist Heat Sterilization Processes
Cycle Design, Development, Qualification and Ongoing Control
Technical Report No. 3, Revised 2013 , Validation of Dry Heat Processes Used for
Depyrogenation and Sterilization
Technical Report 30 Revised 2012, Parametric Release of Pharmaceuticals and Medical
Device Products Terminally Sterilized by Moist Heat
Technical Report No. 48, Moist Heat Sterilizer Systems: Design, Commissioning,
Operation, Qualification and Maintenance
Technical Report No. 61, Steam In Place