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 ...

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 ...

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 ...

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), ...

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 ...

A technician at Microtest performs bioburden testing using the aseptic technique. There are no commonly accepted levels of environmental bioburden. Industrial sterilization and contamination control ...