Excluding bacterial spores from aseptic compounding

Published: 5-Dec-2017

Validation of compounding is essential in demonstrating that appropriate controls are in place to maintain asepsis of the process and the sterility of filled products required for patient safety. Cherwell Laboratories’ Andrew Ramage and Andrew Barrow describe how, in collaboration with Great Ormond Street Hospital, a multilayer packaging solution for a bacteriological medium was developed to prevent misleading false results in compounder use validation

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It is well recognised that patient health can be seriously compromised by microbiological contamination of compounded medicines, particularly in the most vulnerable patients. A combination of inadequate facilities, unsanitary conditions and deficient cleanroom practices in countries lacking the necessary regulation, has led to numerous infection outbreaks from contaminated compounded medicines.

Even in well-regulated countries, some companies that fail to monitor and maintain good practice during the compounding process can still slip through the net. For example, steroids for epidural delivery, manufactured at the New England Compounding Centre in 2012, were found to be contaminated with fungal spores leading to over 700 reported cases of meningitis and 64 deaths.1-4

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