The traditional method of big batch manufacturing must change as companies move away from the one-size-fits-all blockbuster model toward more innovative, targeted biologics that deliver better outcomes.
AseptiSafe aseptic transfer Split Butterfly Valves (SBV) provide improved sterility assurance during powder handling operations in aseptic processing. This animation shows how the AseptiSafe system can be used in conjunction with generic sterilization machines and dedicated cleaning stations to ensure the SBV Passive connection and container is suitable sterilized prior to powder dispensing.
Requiring no integrated plant air to function, the Mac Process MCF PowerSaver generates energy cost-savings of up to 50% over conventional high pressure pulse jet or reverse air cleaning systems.
Learn how to employ science-, risk-, and statistics-based approaches to cleaning and cleaning validation at your facility with this free, 100-page e-book, written by a global team of cleaning validation experts, pharmaceutical toxicologists, statisticians, and Six Sigma professionals.
Natural hazard events may seem like distant topics to some in the biopharmaceutical industry, but they hold relevance for all companies. Opportunities exist for risk management, including an important lesson in avoiding the gradual acceptance of such events as normal, until an even greater catastrophic event occurs.
This is Part 2 of a two-part article on objectionable microorganisms in the nonsterile microbiology industry It discusses a risk-based approach to determine if a microorganism is objectionable for an application.
Bioburden is that dirty little topic nobody wants to talk about in mixed company (operations and QA) — a contamination that can get into our products at several entry points. Our fundamental responsibility is to eradicate it, but since it is invisible, we often make believe it doesn’t exist.
This article explains what an objectionable microorganism is and explores the regulatory expectations for objectionable microorganisms in nonsterile products.