Learn about 21CFR.11 and Annex 11 requirements and how you can implement a rapid bioburden analyser designed to meet compliant operation needs.
List view / Grid view
The expression of hydrophilins enables Acinetobacter baumannii to survive without water on hospital surfaces, providing a target for future elimination efforts and a pathway for biologic drug preservation.
Most industries face mould contamination issues, including medical products, hospitals, cosmetics, paint, among others. Learn more about mould and what you can do to combat it.
Discover why Merck’s new MAS-100 Atmos® compressed gas sampler should be your go to for detecting microbial contamination…
Here, EPR summarises Dr William Whyte’s guidance for formally selecting cleanroom monitoring locations and action levels.
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.
Researchers used computational fluid dynamics (CFD) simulations to assess their cleanroom airflow and suggest improvements that would reduce contamination levels.
7 April 2022 | By Charles River
Join experts as they discuss key aspects of microbial investigations, helping you to understand and implement the new PDA Technical Report 88, and sharing their experience of investigating various microbial events in the real world.
Learn how the pharma supply chain is evolving, the role of real-time data in critical cold chain shipments and how to increase & improve visibility.
This guide explores critical concepts that supply chain professionals need to know about tracking and analysing cold chain pharmaceutical shipments.
On 30 November and 1 December 2021, European Pharmaceutical Review hosted its first ever event – The Future of QA/QC for Complex Biologics Online Summit. Bringing together more than 600 attendees, 15 expert speakers and Thermo Fisher Scientific and Merck as sponsors, the summit gave industry experts the chance to…
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…
This whitepaper considers sterility testing to support pharmacopoeial monographs with an emphasis on products that are difficult to test or validate.