New data shows that the majority of fungal genera isolated from a GMP cleanroom are filamentous and likely transferred into the facility from outside.
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In this article, Liz Thorn, Senior Consultant, Diagnostics at Team Consulting, explores the various in vitro diagnostics (IVDs) techniques available and where they are best applied in the context of influenza and COVID-19.
An evaluation comparing Limulus amebocyte lysate to recombinant alternative assays has found that the recombinant reagents had markedly low recovery of endotoxin activity.
A recently published paper suggests the test panel of micro-organisms needs to be reviewed and likely expanded to ensure it is suitable for application in the pharma industry.
In this video, Dr Tim Sandle explains how COVID-19 has impacted the application of rapid microbial methods (RMM) and much more...
Tim Sandle explains how next-generation sequencing (NGS) could aid in the development of novel antimicrobials to overcome multi-drug resistance.
Rising at a CAGR of 8.2 percent, the rapid microbiology testing market is predicted to grow over the next five years.
Glove prints are the most effective microbiological monitoring method during aseptic handling, finds study
Researchers evaluate the various microbiological monitoring (MM) methods employed inside a laminar airflow or safety cabinet in hospital pharmacies.
The new COVID-19 test, called RTF-EXPAR, was able to accurately detect the presence of SARS-CoV-2 viral RNA in under five minutes.
Lonza’s MODA-EM™ Paperless Solution to be implemented at the UK’s New Vaccines Manufacturing and Innovation Centre
The UK’s Vaccines Manufacturing and Innovation Centre (VMIC) has selected Lonza’s MODA-EM™ Solution to digitise its Microbiology Quality Control operations. The MODA EM™ Platform will form a vital part of ongoing work that will support the VMIC coming online a year ahead of schedule.
This article presents statistics required to validate rapid microbial methods (RMMs) according to the requirements in the most recent version of European Pharmacopoeia (EP) 5.1.6. The validation methods for bioburden test application performed are also described.
Helen Farr, a Partner at Taylor Wessing, discusses the hurdles that life science businesses must tackle to bring employees back to work safely; whether that be working remotely or returning to the lab.
There are numerous risks and regulatory requirements that must be considered to ensure appropriate contamination control of sterile medicinal products. Tim Sandle discusses the complexities of sterility assurance and provides guidance for manufacturers to ensure that appropriate risk management processes are in place.