Monday 15 March 2021

Sterility Testing - Overcoming Difficult Products


The compendial sterility testing of biopharmaceutical products is based upon the addition of aliquots or membranes with the concentrated samples to different types of media.This paper is designed to support pharmacopeial monographs with an emphasis on products that are difficult to test or to validate, offering a practical approach to sterility testing. 


For many of these products there is little in the way of pharmacopeial guidance. Such products include those which contain antibiotics or preservatives and for which a neutralisation step is required. 


Reference is also made to other difficult products like creams, ointments and medical devices. 


Tim Sandle has written his seventh paper for RSSL's sterility series.


The reference is:


Sandle, T. (2020) Sterility testing - overcoming difficult products, RSSL white paper number 7


To downoad the paper, go to: 


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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