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Microbial detection methods are inherently flawed by three key factors, here we summarise Tim Sandle’s explanation of the concerns surrounding microbial methods and sampling.
Learn how you can go about changing QC test methods and how this can go a long way to helping your lab achieve data integrity compliance.
3 August 2021 | By Thermo Fisher Scientific
Join Thermo Fisher Scientific on 7 September at 15:00 BST, to discover the differences between FTIR, NIR and Raman spectroscopy, learn how spectroscopy is applied in quality control labs and hear how implementation of these techniques increased efficiency and minimised costs.
In a review, Tim Sandle sets out what disinfectant validation studies should assess and why those factors are important when choosing cleanroom disinfectants.
See how a pharma company maintained product quality and reduced risk by using an RMM analyser, while also meeting their goal of reducing plate counts by 25 percent.
Research suggests the adoption of microbial air samplers to overcome COVID-19, as well as the growth of the pharmaceutical sector will both drive market development.
Biogen and Ionis announced positive topline data on investigational Alzheimer’s treatment, indicating 50 percent tau protein reduction.
See how a leading biopharma company used an RMM analyser in parallel to plate counts to find the root cause of periodic bioburden excursions in its water system.
In this final article on the TRIPS waiver for COVID-19 vaccines, medicines, diagnostics and technologies, EPR’s Hannah Balfour considers whether it is the correct strategy to overcome COVID-19 treatment inequalities and explores other options.
Learn how Mibelle Group improved their process control strategies using the 7000RMS analyser in parallel with validated plate counts.
This whitepaper discusses cleaning validation and the considerations required for a successful outcome.
This paper explores the presence of biofilm in hot WFI systems and the use of rapid microbial methods to overcome the limitations of plate counts.
The European Pharmacopoeia will put an end to the rabbit pyrogen test in the next five years and encourages industry to adopt the monocyte-activation test instead.
Timelines for assessing the potential for contamination of medicinal compounds with nitrosamines have been revised. Here, Dave Elder explains the EMA’s and FDA’s positions and the likely scenarios to be encountered.
New data shows that the majority of fungal genera isolated from a GMP cleanroom are filamentous and likely transferred into the facility from outside.
