Thursday 17 September 2020

Release of sterile products – looking at the focal points

There are numerous risks and regulatory requirements that must be considered to ensure appropriate contamination control of sterile medicinal products. Tim Sandle discusses the complexities of sterility assurance and provides guidance for manufacturers to ensure that appropriate risk management processes are in place.

In relation to this, Tim Sandle has written an article for European Pharmaceutical Review. The article can be accessed here.

Sterile products manufacturing has the added complexity that the final product needs to be sterile (absent of viable microorganisms and microbial by-products, such as bacterial endotoxin). Especially given that sterility cannot be conclusively tested (the sterility test, while mandatory of aseptically filled products and some terminally sterilised products is inherently flawed; not least because not all microorganisms in the environment are culturable and there is no universal means to grow them). Therefore, there is reliance upon a robust sterility assurance system. The person tasked with batch release must be aware of the risks centred on the release of contaminated product to the market and associated risks of patient harm.

The reference is:

Sandle, T. (2020) Release of sterile products – looking at the focal points, European Pharmaceutical Review, 25 (04): 6-11

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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