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How should environmental monitoring locations be chosen?
Here, EPR summarises Dr William Whyte’s guidance for formally selecting cleanroom monitoring locations and action levels.
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Microbial Detection
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Guide to Testing
Welcome to European Pharmaceutical Review’s Guide to Testing. In this edition, Oliver Großgart, Plant Safety Expert at TÜV SÜD Industrie Service GmbH, discusses the benefits of leveraging acoustic emission testing to identify faults in compressed air pressure vessels, and Associates of Cape Cod and SGS Health Science showcase their services,…
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WuXi Biologics awarded for excellence
WuXi Biologics awarded the Bioprocessing Excellence in Viral Clearance and Safety accolade for the second time at the Asia-Pacific Bioprocessing Excellence Awards (ABEA) 2022 event.
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Tracking and tracing to the root cause: case studies in microbial contamination
In this article, pharmaceutical microbiologist and contamination control expert Tim Sandle presents three microbial contamination investigation case studies, highlighting the key lessons for pharmaceutical microbiologists to take away and the underlying importance of identifying the root cause of microbial data deviations.
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Enhancing rapid microbiology methods: how AI is shaping microbiology
Rapid microbiological methods are being enhanced by artificial intelligence (machine learning in particular). The aim is to speed up analysis; increase accuracy; avoid error and introduce a level of automation. Examples include microscopy, colony counting, and microbial characterisation and matching – each of which is based on improvements in image…
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Application Notes Supplement 2021
Here, industry experts from bioMérieux Industry, Charles River, Shimadzu, TA Instruments, Thermo Fisher Scientific and WITec share their research, guidance and pharmaceutical knowledge.
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QA/QC Raman & RMM In-Depth Focus 2021
In this in-depth focus, discover how Raman spectroscopy is used by Bristol-Myers Squibb to identify counterfeit pharmaceuticals and the role of artificial intelligence in rapid microbiological method development.
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European Pharmaceutical Review Issue 6 2021
This journal features articles discussing what knowledge could help the industry to prevent the next nitrosamine-like contamination event, the key steps when validating analytical techniques for cell and gene therapies and how artificial intelligence is shaping microbiology. Also in this issue, using Raman spectroscopy and hyperspectral imaging to detect counterfeit…
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Future of QA/QC for Complex Biologics Whitepaper
Download this whitepaper to discover the latest developments and research in QA/QC for biologic therapies via exclusive articles, interviews and application notes.
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Why is there no standard MALDI-TOF MS procedure for bacterial identification?
Here, EPR summarises a review outlining how different sample preparation protocols, culture media and conditions affect MALDI-TOF MS identification of bacteria.
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Do we need gloves? Cleanroom dressing processes may not, finds study
Research indicates, with robust handwashing protocols, there is no difference in cleanroom garment bacterial contamination with or without gloves in the dressing process.
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Is your microbial air sampler fit for purpose?
Here, EPR summarises Tim Eaton’s explanation of the importance of assessing biological collection efficiency when selecting an air sampler.
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New FDA draft guidance on microbiological quality of NSDs
The draft guidance discusses product development considerations, risk assessments and cGMPs relevant to microbiological control in non-sterile drug (NSD) manufacturing.
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Biological safety cabinet safest place for parenteral product compounding, says study
Researchers recommend the biological safety cabinet be used whenever possible to compound parenteral products in a clinical setting.
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Data integrity is a key concern with microbial methods, says expert
Dr Tim Sandle explains that, whether rapid or conventional, documented on paper or computer, microbial methods must have data integrity.
