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 ...

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 ...

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 ...

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 ...

This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to ...

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), ...