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Real-Time Viable Particle Detection For Definitive Root Cause Investigation By Mike Dingle, Field Application Specialist, TSI Inc. Investigations into viable air excursions are very difficult to perform using traditional methods. The data generated is very limited and not very timely. This often leads to high levels of frustration as the problem persists, with vast amounts of time and resources being consumed while the root cause remains elusive. No matter how extensive the investigation, due to the limitations of the traditional tools available, luck often plays a large role in actually iden...

Deal calls for production of over 100 million doses of Sputnik V vaccine in China.

An Introduction To Trending In Environmental Monitoring Programs Trending environmental monitoring (EM) data is a regulatory requirement. However, it is useful in obtaining significant information about the facility. Trends can help determine if a facility is in a state of microbial control and relay the environmental monitoring data to facility management in a meaningful format. In this two-part article exploring environmental monitoring trending, I look first at the regulations and guidelines around EM. In part two, I will discuss tools and best practices for using the trends to ensure that...

Robotic Aseptic Processing: Utility in the Filling of Syringes, Cartridges and Ready-to-Use Vials The last stage before the product is packaged and administered to the patient is known as fill-finish. The biopharmaceutical industry is transitioning to smaller aseptic batch manufacturing processes as patient treatments move toward the targeted treatment of smaller (personalized) patient populations and away from broad population therapies. It was not long ago that robots were focused on end-of-line functions in the pharmaceutical industry, like palletizing and case packing. Robotic integration...