whitepaper
Whitepaper: Manage Your Risk: Monitoring the Environment of Aseptic Processes
Risk assessment consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards.
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Microbiology
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Do viability methods detect all viable organisms?
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.
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Assessing host cell protein contamination in biotechnological products
Purification of a drug from host cell protein contaminants can be challenging, with low-level contamination often remaining after purification. Vanda Dolabela de Magalhães shares discussions on the subject from six Brazilian companies working in the biotech field.
video
On-demand webinar: Streamline your Rapid Microbiological Method Validation
When it comes to microbial contamination testing, false results can waste valuable time.
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Data integrity for cleanroom monitoring
With a continual focus on data integrity and helping our customers meet regulations while generating actionable insights, Particle Measuring Systems provides a complete range of products and services.
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QA/QC & Analytical Techniques In-Depth Focus 2019
Analytical techniques for QA/QC purposes are integral to the safe production of therapeutics. This in-depth focus looks at Raman spectroscopy for amorphous phase analysis and discusses the viable but non-culturable (VBNC) state of bacteria in environmental monitoring.
news
Heritage announces product recall after sterility test failure
Heritage has recalled two of its injectable treatments after microbial growths were found.
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Concerns around Annex 1
This article expresses the opinions of a pharmaceutical microbiologist on the proposed revisions to the EU Good Manufacturing Practice Annex 1 in terms of current industry practice and future innovation in sterile product manufacturing.
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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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Wickham Laboratories Ltd: backed by five decades of global experience
Wickham Laboratories Ltd, backed by five decades of global experience in GMP/GLP-regulated laboratory services, is an established name in the fields of pharmaceutical and medical device contract testing, research and consultancy.
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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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It’s not just about the science: microbiological analysis
Modernisation of microbiological test methods involves far more than just the science. As new systems and technologies become available it becomes increasingly important that potential users can identify not only the technical requirements, but also the business case. Here, Paul Newby, Alice Laures and Lisa Wysocki from GlaxoSmithKline discuss criteria…
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European Pharmaceutical Review Issue 2 2019
This issue questions whether companies are sufficiently investing in regulatory intelligence software and what the potential consequences of Brexit might be for locations outside of the UK and EU. The issue also features articles on microbiology, formulation and biopharma, courtesy of our in-depth focus sections; as well as outlining the…
news
Industry experts combine to create safer intravenous delivery
The Italian Biochemical Institute, Comecer, and Particle Measuring Systems share expertise to develop and manufacture a safer intravenous solution...
product
Product Hub: Multitron incubation shaker
The Multitron is the number-one choice for reliable, convenient cultivation of microorganisms and cell cultures. The incubation shaker guarantees homogeneous conditions and delivers reproducible results, leaving nothing to be desired regarding its features and capacity.
