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Your endotoxin experts
The future of sustainable LAL testing has arrived with ACC’s PyroSmart NextGen recombinant LAL reagent technology for bacterial endotoxin testing (BET).
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rapid endotoxin testing
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Application note: A new, more flexible endotoxin test platform
This application note discusses some of the critical issues users experience with endotoxin testing around accuracy, flexibility, sustainability and platform cost.
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Nelson Labs: supporting internal quality processes
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,…
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Charles River microbial solutions
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…
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Microbiology In-Depth Focus 2019
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…
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Whitepaper: Analytical criteria in bacterial endotoxin testing using LAL and rFC
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…
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Review of regulatory changes impacting on pharamceutical microbiology
23 December 2014 | By Dr Tim Sandle, Bio Products Laboratory
This article surveys some of the recent developments in regulatory requirements and standards that have taken place during the past 12 months, highlighting those aspects that are of relevance to pharmaceutical microbiology...
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Article 5: The implementation of rapid microbiological methods
1 November 2010 | By Michael J. Miller, President, Microbiology Consultants, LLC
This is the fifth in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2010. In my previous four articles, I have provided an overview of the benefits of rapid microbiological methods (RMMs) as compared with conventional methods, validation strategies and regulatory perspectives…
