news
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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Microbiology
video
On-demand webinar: Spores in my cleanroom
This webinar considers the problems bacterial and fungal spores present for contamination control and remediation and disinfection strategies.
news
New FDA draft guidance on microbiological quality of NSDs
The draft guidance discusses product development considerations, risk assessments and cGMPs relevant to microbiological control in non-sterile drug (NSD) manufacturing.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.
whitepaper
Whitepaper: Best practices in environmental monitoring
This whitepaper outlines the important components of an environmental monitoring programme, providing practical advice and best practice guidance.
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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.
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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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Bacterial Endotoxin Test using LAL methodology: overcoming interfering factors
The Bacterial Endotoxin Test, using LAL methodology, is a key in-process and final product release test for sterile pharmaceuticals and medical devices. One of the challenges with LAL methodology is overcoming interfering substances as demonstrated by inhibition or enhancement of an endotoxin challenge. Here, Bio Products Laboratory’s Dr Tim Sandle…
news
Flow cytometry to advance decontamination and sterilisation processes
A new paper reveals how combining flow cytometry with other analytical techniques can provide a wealth of information on bacterial viability and thus enhance sterilisation processes.
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Infrared thermography can detect pre-visual bacterial growth, shows study
A new paper shows thermal imaging (infrared thermography) can detect E. coli and S. aureus bacteria after just six hours of incubation, long before it is visible to the human eye.
whitepaper
Worksheet: ARMM technology comparison
This worksheet can be edited to include specifications discovered during your evaluation of Alternative Rapid Microbiological Method Technologies.
whitepaper
Whitepaper: How digital modelling supports cleanroom design
In this whitepaper, C2C’s Product & Process Development Lead explains how using digital modelling in the design process can guarantee results.
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Understanding limitations of microbial detection methods is key, says expert
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.
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On-demand webinar: The art of changing QC testing methods
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.
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Are your disinfectant validation protocols fit for purpose?
In a review, Tim Sandle sets out what disinfectant validation studies should assess and why those factors are important when choosing cleanroom disinfectants.
