The article discusses specific challenges we face when preventing microbial growth, considering the regulations & validations of drug products and why efficacy is the main concern in active ingredients.
An excerpt of this article is as follows:
When considering the regulation and validation of drug products, the efficacy of the active pharmaceutical ingredient (API) is often a concern; ensuring the compound elicits the appropriate effect at the correct target site is crucial. Another regulatory requirement of drug development and manufacturing is guaranteeing that no inappropriate organisms can sustain themselves within the product or its packaging.
Antimicrobial preservatives are added to pharmaceuticals, medical devices, personal care products, cosmetics and food products to inhibit the growth of microorganisms inadvertently introduced during the manufacturing process or during the use of products with multiple-dose containers. Preservative efficacy testing (PET) (also known as antimicrobial effectiveness testing) is undertaken to ensure that the preservative maintains its ability to inhibit microorganisms, and is required by British Pharmacopoeia (BP), European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP) standards.
If you are interested in reading the digital article in full, please visit the Cleanroom Technology website.
Editorial
Article on the Preservative Efficacy Test (PET) and Challenges in Preventing Microbial Growth
Posted 30th October 2018 by Tasmin Stock
Wickham Laboratories are excited to announce their latest article being published by Cleanroom Technology in November, “Testing Preservatives with PET”, written by Microbiology Business Support Coordinator, Tasmin Stock.
