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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.
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,…
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.
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…
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…
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…
The Italian Biochemical Institute, Comecer, and Particle Measuring Systems share expertise to develop and manufacture a safer intravenous solution...
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.
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…
11 February 2019 | By Particle Measuring Systems
Following the patent of the "Espresso" innovative infusion device, the Italian Biochemical Institute (IBI) "Lorenzini" commissioned Comecer to construct a new isolated filling line.
Wickham Laboratories Ltd is delighted to announce our most recent technical article on, “microbiological considerations in cleanroom validation”, which has been featured in European Pharmaceutical Review’s December 2018 issue...
Rapid microbiological methods (RMM) continue to gain acceptance within our industry and a number of companies have already realised significant gains in detection sensitivity, automation, throughput, time-to-result and return on investment (ROI) when they have replaced their classical methods with these alternative technologies.
22 January 2019 | By SUEZ
Register for our latest webinar on the proposed Annex 1 revision on pharmaceutical water to prepare for future compliance...
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…
Presenting solutions that Particle Measuring Systems provide in total concept including training, services and their FMS system which monitors instruments.
