news
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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Cleanrooms
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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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CFD airflow stimulations can help enhance cleanroom contamination control, finds study
Researchers used computational fluid dynamics (CFD) simulations to assess their cleanroom airflow and suggest improvements that would reduce contamination levels.
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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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Scrubbing up the environment
Here, colleagues from University Hospitals Bristol and Weston NHS Foundation Trust (UHBW) share the beneficial impact of reduced cleanroom environmental contamination following an upgrade to their facilities and procedures.
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Microbial air sampler market to value $545mn by 2028
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.
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Understanding your cleanroom fungi is key, says expert
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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ebook: Important considerations for every bio-pharmaceutical microbiology QC lab
This ebook from Sartorius takes an in-depth look at how the quality control (QC) microbiology laboratory plays a critical role in control of the pharmaceutical manufacturing environment and product release.
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Cleanroom infrastructure innovation to fulfil the needs of cell and gene therapies
Biopharmaceuticals have transformed the patient care landscape, but alongside this step change in treatment capability comes the need for a similar paradigm shift in manufacturing capability. Here, Maik W Jornitz, President & CEO of G-CON Manufacturing Inc. highlights how cleanroom infrastructure must develop to keep pace with ever evolving industry needs.
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Is the compendia-recommended microorganism test panel truly representative?
A recently published paper suggests the test panel of microorganisms needs to be reviewed and likely expanded to ensure it is suitable for application in the pharma industry.
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Discussing developments in RMM with Dr Tim Sandle, Bio Products Laboratory
In this video, Dr Tim Sandle explains how COVID-19 has impacted the application of rapid microbial methods (RMM) and much more...
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Nelson Labs: supporting internal quality processes
Nelson Labs is the leading global extractables and leachables lab testing platform, in this guide find out about their other services and how, from development to delivery, they can help get your products to market.
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Bioprocessing & Bioproduction In-Depth Focus 2021
Featured in this in-depth focus, articles exploring why cleanroom infrastructure must transform to meet the needs of the cell and gene therapy industry and discussing a novel platform for discovering and developing genetically-targeted therapies for autoimmune diseases.
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Pharmaceutical sterility testing market to value over $1000 million by 2027
Reports suggest the global sterility testing market will grow because of the expansion of pharma and biopharma, increasing R&D activities and the launch of new products.
