Teknipure’s Technical Insights offer concise, expert guidance on cleanroom testing, applications, and product selection – helping improve contamination control, compliance, and make informed decisions.
Issue 1: Endotoxin Testing for Cleanroom Wipers
in Pharmaceutical Manufacturing
In pharmaceutical manufacturing, maintaining a sterile and contamination-free environment is not just a matter of operational efficiency but a regulatory and safety imperative. Endotoxins can persist even after sterilization and pose a serious risk when introduced into pharmaceutical products, especially injectables, biologics, and medical devices. Among the various sources of contamination, cleanroom wipers—integral to surface cleaning and aseptic practices—must be stringently controlled for endotoxin levels. This article delves into the significance of endotoxin testing for cleanroom wipers and outlines best practices and regulatory considerations.