List view / Grid view

Microbial Detection

 

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,…

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…

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…

Microbiology In-Depth Focus 2017

19 October 2017 | By

The European Pharmacopoeia chapter on methods for microbiological quality control was recently revised to include a number of significant changes. In this In-Depth Focus Michael Miller provides the first part of this two-part review and Kevin Williams discusses a paradigm change in biologics microbiological contaminant control.

The people factor: investigating the gown

1 August 2017 | By

An effective environmental monitoring programme is designed to estimate the microbial content of the room’s air and surfaces (by incident rate, against alert and action levels, and by assessment of different species) for operations performed within a cleanroom or controlled environment.