1. Routine biological controls applied to injectable drugs and sterile, non-pyrogenic medical devices

by Delphine VERJAT-TRANNOY and Cyril VADROT

Sterility and apyrogenicity, defined as the absence of viable micro-organisms and pyrogenic substances respectively, are microbiological quality and safety criteria for the administration of drugs or the use of medical devices in humans. Control of these parameters, in terms of objectives, operating conditions and interpretation of results, is governed by European and American regulations and standards: Pharmacopoeia for drugs and standards for medical devices. The following paragraphs summarize the main principles of these texts, with explanations and practical advice to help you implement them.