Here, EPR summarises a review outlining how different sample preparation protocols, culture media and conditions affect MALDI-TOF MS identification of bacteria.
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Research indicates, with robust handwashing protocols, there is no difference in cleanroom garment bacterial contamination with or without gloves in the dressing process.
The draft guidance discusses product development considerations, risk assessments and cGMPs relevant to microbiological control in non-sterile drug (NSD) manufacturing.
Researchers recommend the biological safety cabinet be used whenever possible to compound parenteral products in a clinical setting.
This whitepaper outlines the important components of an environmental monitoring programme, providing practical advice and best practice guidance.
Dr Tim Sandle explains that, whether rapid or conventional, documented on paper or computer, microbial methods must have data integrity.
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…
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.
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.
In this whitepaper, C2C’s Product & Process Development Lead explains how using digital modelling in the design process can guarantee results.
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.