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 ...

Bioburden testing serves a variety of purposes, and the relevance of the data can range from relatively insignificant to extremely critical. Bioburden tests can be used for general tracking 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 ...

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 Global Bioburden Testing Market has experienced consistent growth, with a compound annual growth rate (CAGR) of 12-15%. This growth is driven by tightening regulatory standards and an increasing ...

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 ...