Ensuring the integrity of container closure systems (CCS) is critical for the safety and efficacy of high-risk drug products. This whitepaper explores the regulatory landscape, key testing methods, and risk-based approaches required to qualify CCS for parenteral and ophthalmic applications....
Contamination from ethylene glycol and diethylene glycol in liquid formulation poses a high risk to patient safety. Throughout recent years there have been multiple fatalities reported due to the presence of these contaminants in drug products. This whitepaper covers the...
Container closure integrity, which is verified by container closure integrity testing (CCIT), is critical to ensure the sterility of drug products. Physical, chemical, and biological assessments must be carried out to make sure components are compatible and fit for use....
In this article published in Pharmaceutical Technology, Susan Schniepp and Shiri Hechter explain how an analytical method to be used for routine testing but not published in a pharmacopeia can be validated. Read Full Story
Nelson Labs introduces RapidCert™ biological indicator (BI) sterility testing (patent pending), which can significantly accelerate confirmation of sterility.
