In this series, a particle counter’s ideal flow rate is examined through the lens of particle loss in connecting tubing. The mathematical basis for particle loss causation is discussed and applied to the results of testing a 100 LPM device for 0.5 um and 5.0 um particle losses within 2 m tubing.
In this six-part blog series, we examine common issues with data transfer, integrity, analysis, reporting and storage that we encounter as cleanroom owners and users every day. We’ll explore how automation and electronic solutions, within the parameters of Regulatory Authorities and cGMP, can help improve efficiency and product quality.
Our last blog on this topic discussed the technological advances that have changed sterility assurance. Today we address rapid microbiology methods and the impact on sterility assurance. Environmental Monitoring (EM), particularly in Pharmaceutical manufacturing facilities, where the risk of microbial contamination is controlled through aseptic processing, comprises both physical and…
Following the last blog, which discussed the regulations and guidelines surrounding advances in sterility assurance, we move on to discuss the technological progress that has made advances in sterility assurance possible.
