There are numerous risks and regulatory requirements that must be considered to ensure appropriate contamination control of sterile medicinal products. Tim Sandle discusses the complexities of sterility assurance and provides guidance for manufacturers to ensure that appropriate risk management processes are in place.
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20 August 2020 | By SUEZ
The new Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform combines ground-breaking technology and ease-of-use to automate endotoxin assay setup without altering reaction biochemistry or compliance.
29 July 2020 | By Charles River
In this webinar we will be discussing the results of our latest study where we evaluated the ruggedness, repeatability and specificity of commercially available rFC products, as well as our own recombinant product in development, against a large panel of endotoxins.
Watch our quick learning and learn in only 10 minutes what key challenges manufacturers are facing when selecting media for media fill tests and how to overcome them.
The impact of rapid microbiological methods (RMM) on the scientific community has been widespread and profound. Lucpah Nekati explains how their numerous benefits enable deeper understanding, faster and more easily.
Application note: Application of flow cytometry for microbiological monitoring of pharmaceutical grade water
As the main excipient for the pharmaceutical industry, water is integral to patient safety and the quality of pharmaceutical products.
This application note shows the neutralisation efficiency of ICR swabs for sanitsed surfaces in aseptic manufacturing environments.
This application note shows the detection of low numbers of different bacterial test strains from Neoprene® gloves.
All drug products have to undergo sterility testing to comply with Good Manufacturing Practices (GMP). Rapid sterility testing, which offers an incubation period of five days or less, provides a solution.
Essential points of active air sampling units for use in your high-grade cleanrooms, along with requirements for prevention of cross-contamination.
The manufacturing process does not always allow for immediate transfer of samples to the incubator space and may be pre-stored.
This webinar will address the evaluation of microbiological, environmental monitoring data as well as what would be considered significant differences in data.
Marc Baiget Francesch explains how commensal bacteria can be opportunistic pathogens and why treating them as merely a light threat to cleanrooms can bring disastrous consequences.
Researchers have developed a novel microrobot made from bacteria and red blood cells which they say could be an effective form of drug delivery.