Managing the risks associated with potent compounds requires a knowledgeable team as well as the design and implementation of an effective safety program.
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.
Use of environmental isolates in the pharmaceutical microbiology laboratory has been increasing in popularity. This article discusses the current regulations andguidance documents, regulatory expectations, and expert opinions on the use of environmental isolates.
Measurable benefits of off-site module construction are becoming more evident, and it is emerging as a viable method for delivering a greater degree of predictability. Furthermore, market constraints driven by shortages of craft labor, lagging productivity, project complexity, and competitive forces are contributing to biopharma’s move toward modularization.
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.