Release of sterile medicinal products – looking at the focal points
Posted: 25 August 2020 | Tim Sandle (Bio Products Laboratory and University of Manchester) | 2 comments
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.
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.
With sterile products, there are three main types:1 parenteral dosage forms, ophthalmic dosage forms and aqueous inhalations; two main methods of production: terminal sterilisation and aseptic filling; plus, different presentations: glass ampoules and vials, pre-filled syringes, plastic ampoules and vials, and plastic bags.