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This article presents statistics required to validate rapid microbial methods (RMMs) according to the requirements in the most recent version of European Pharmacopoeia (EP) 5.1.6. The validation methods for bioburden test application performed are also described.
29 July 2020 | By Charles River
In this webinar we discuss 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.
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.
In this whitepaper, bioMérieux describe the potential application of BioFire® FilmArray technology – a well-recognised technology used in infectious disease diagnostics – for rapid at-line detection of mycoplasmas in the pharmaceutical industry.
Within this in-depth focus are features on the uses of Raman imaging in the pharmaceutical industry and the benefits of utilising rapid microbiological methods (RMM).
In this issue is a discussion on the promise of virally vectored DNA and mRNA vaccines to combat COVID-19 as well as articles on how packaging could help to ensure patient adherence, regulatory issues for medicines and diagnostics during the pandemic and the benefits of digitalising the pharmaceutical supply chain.…
Facilities perform environmental monitoring (EM) to demonstrate a state of control.
Many bacterial species have been found to exist in a viable but non-culturable state. Jeanne Moldenhauer discusses this phenomenon and makes suggestions as to why we don’t often see an increase in viable cells when using viability-based methods.
When it comes to microbial contamination testing, false results can waste valuable time.
Nelson Labs has a long history of partnering with pharmaceutical and biopharmaceutical companies. We perform a variety of testing to support your internal quality processes including: sterility (USP 71) testing in a cleanroom for isolator environment, particulates testing (USP 787, 788) using a variety of methods, bacterial endotoxin, filter validations,…
Those who work in QC know that the job is more than a box to be checked, and that it can’t be done effectively without confidence in the reported results. Tight timelines, regulatory demands, and stringent data integrity standards can make it hard to focus on what’s really at stake…
The work of a pharmaceutical scientist requires precision, attention to detail and is of vital importance to the safety of products and ultimately patients. This section features insights from experienced scientists who’ve worked extensively in microbiological analysis, developing tests, methods and standards that help establish a foundation for the production…
In this edition of our ‘Guide to’ series, learn how these leading companies’ services and expertise can help you test your pharma/ biopharma products and medical devices.
The Italian Biochemical Institute, Comecer, and Particle Measuring Systems share expertise to develop and manufacture a safer intravenous solution...
This article covers the analytical criteria that apply to Bacterial Endotoxin Testing (BET) using Limulus Amebocyte Lysate (LAL) or recombinant Horseshoe crab Factor C (rFC) for the bioactivity determination of endotoxin in aqueous solutions, such as pharmaceuticals and medical device extracts. It explains the importance of these criteria for accurate…
