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 ...

A key aspect of the validation of a sterilization process, irrespective of the sterilizing agent, is an understanding of the product bioburden. This understanding must be both quantitative and ...

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 ...

The preparation of media for use in biopharmaceutical processes can be complex and may carry risks that must be identified, assessed and mitigated to assure consistency of performance and minimize ...

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 ...