PARTNERS FOR THE PERFECT PET

摘要

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.