When sterilizing medical devices, sterilization personnel rely on bioburden counts as part of determining and maintaining the sterilization process. In the following Q&A, Martell Winters, senior ...

Note: This article is based on the white paper "Establishing Bioburden Alert and Action Levels" available for download. Most national and international standards regarding bioburden, sterilization, or ...

The bioburden testing market presents opportunities driven by stringent regulations and the need for contamination control in ...

As biopharma companies fine-tune their strategies for continuous bioprocessing, bioburden control has become a top priority. The approaches that worked for batch processing are inadequate for ...

A company's contamination-control plan is an important document designed to formalize the rationale, methods, and validation of contamination-control procedures in a manufacturing facility. The author ...

Methods to Simultaneously Reduce Bioburden and Maintain Column Integrity, Explained Continuous bioprocessing is inevitably becoming the future of biomanufacturing. To date, several steps within a ...

The quality of water for pharmaceutical production (purified water, water for injection, and ultrapure water) is quantified and regulated through four parameters – total organic carbon (TOC), ...

The author clarifies the definition and objectives of overkill sterilization for steam sterilization cycles. Current sterilization practices are reviewed and the validation difficulties associated ...

Fully cell-free process aims to further democratize personalized cancer therapeutic manufacturing with shorter turnaround times and negligible bioburden and endotoxin risks. As late-stage PCT clinical ...