Validation of Pharmaceutical Processes: Sterile Products, Second Edition
Featuring contributions from 25 specialists, this book provides a single-source reference on the design of systems, qualification of equipment, calibration and certification. It covers explicit procedures for the validation of systems required in the preparation of aseptic and nonaseptic pharmaceutical products. Topics include installation qualification, operational qualification, and change control, F, D, and Z values, steam sterilization-in-place technology and validation, sterilization methods, protocols that allow procedures to be applied directly, obstacles that may be encountered at any stage of the validation program, and suggested solutions.
What people are saying - Write a review
Hi, I refer this book very frequently.
It is a very good book to understand and implement the basics of Sterilisation/Deparogenation.
When I am on the page no. 392,I got confused? Is it an typographical error or is there any other calculation?
In the eaxample, required F0 is mentioned as 8.8 minutes.
I think it should be F0=26.4.
Other editions - View all
Encyclopedia of Pharmaceutical Technology, Second Edition, 2004 Update ...
No preview available - 2004