video
On-demand webinar: Designing an End-to-End Sterility Assurance Program
Sterility assurance for a pharmaceutical product is critical, and includes many aspects outside of the actual sterilization cycle or aseptic process.
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Microbiology
news
Voluntary recall issued for lidocaine cream and liquid gel products
Lidocaine topical cream and liquid gel products are being recalled as the lidocaine amount is higher than the label states.
webinar
Accelerate food, pharmaceutical and particle analysis with Raman imaging
7 August 2019 | By WITec GmbH
This webinar describes how Raman microscopy can help solve some of the most vital and challenging questions that researchers face in 3D imaging and microparticle analyses of food, pharmaceuticals and microplastics, along with providing measurement examples from each field.
whitepaper
Whitepaper: Does QRM + RMM = Better EM
Facilities perform environmental monitoring (EM) to demonstrate a state of control.
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.
article
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.
article
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.
article
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.
article
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.
article
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,…
article
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.
article
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…
