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Microbial Detection

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Pernicious microorganisms: risks of contamination in pharma

18 November 2019 | By ,

Some pharmaceutical manufacturers can struggle to keep microorganisms away from their facilities, which sometimes goes unnoticed until it is too late. While there are numerous threatening microorganisms, this article focuses on some of the most troublesome, highlighting the hazards they pose and analysing how manufacturers can prevent microbial contamination in…

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Quality control solutions that fuel confident decisions

7 November 2019 | By

As the partner of choice for managing microbial quality control, Charles River’s products and services facilitate confident and objective decision-making, ensuring the integrity of your microbial data, reducing risk, building efficiency and improving your bottom line, while assisting in the journey to bring products to market.

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Nelson Labs: supporting internal quality processes

14 May 2019 | By

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

8 May 2019 | By

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…

Whitepapers/App Notes/Posters

Whitepaper: Analytical criteria in bacterial endotoxin testing using LAL and rFC

21 February 2019 | By

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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Real-time PCR detection of S. aureus in pharmaceutical products

21 December 2018 | By , , , ,

The contamination of pharmaceuticals by microorganisms represents a major threat to public health, not just in the USA and Europe, but all around the world. Pathogenic microorganisms cause morbidity and in some cases mortality when present in products.1,2 Spoilage due to microbial breakdown of formulations can affect potency and shelf…