Descrição
CONTENTS:
Sterility
History of the Sterility Test
Sterility Test Regulations
Sterility Test: The Pharmacopeia Culture Based Method
Practical Approaches to Sterility Testing
Controlled Environments for Sterility Testing
Culture Media for the Sterility Test
Rapid and Alternative Methods for Sterility Testing
Investigating Sterility Test Failures
Auditing Sterility Testing
Evaluating the Sterility Test
Alternatives to Sterility Testing: Parametric Release
Final Product Release
The Sterility Test and Sterile Products: Thoughts on Definition and Application
