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.
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A discussion between experts Roger Haas, Head of Environmental Monitoring Franchise at Merck KGaA, Darmstadt, Germany, and Ronny Zingre, CEO of MBV AG.
Researchers reveal their experimental test can detect the presence of COVID-19 RNA in a sample in 10 minutes, and in a way that does not require trained personnel to interpret.
Researchers have identified 27 biomarkers that could be used to predict the course of SARS-CoV-2 infection and whether a patient with COVID-19 will become severely ill.
Marc Baiget Francesch explains how commensal bacteria can be opportunistic pathogens and why treating them as merely a light threat to cleanrooms can bring disastrous consequences.
A team have developed a biosensor with high specificity and sensitivity for COVID-19 that could be used in hospitals, train stations or laboratories to detect SARS-CoV-2.
The active air sampler market, led by Asia-Pacific, Europe and US, is expected to grow from its current value of $92 million at a CAGR of 5.1 percent.
The institute has paused cancer research and repurposed its laboratories and scientists to provide a rapid COVID-19 testing facility for NHS staff and other key workers.
Research has developed bandages which change colour and release antibiotics and/or reactive oxygen species in response to an infected wound which could curb the spread of antibiotic resistance.
Clinical microbiologists have started using new, non-conventional methods to study the microbiology of the human gut. In this article, Jeanne Moldenhauer discusses the intricacies of culturomic and metagenomic studies and how this can advance current research.
Since it was discovered in the 1920s, Raman spectroscopy has been used in pharmaceutical research as a non‐invasive way to provide chemical and structural information in situ, without any staining or complicated sample preparation. Nikki Withers spoke to Professor Kishan Dholakia to hear more about its use in industry and…
Some pharmaceutical manufacturers can struggle to keep microorganisms away from their facilities, which sometimes goes unnoticed until it is too late. While there are numerous threatening microorganisms, this article focuses on some of the most troublesome, highlighting the hazards they pose and analysing how manufacturers can prevent microbial contamination in…
As the partner of choice for managing microbial quality control, Charles River’s products and services facilitate confident and objective decision-making, ensuring the integrity of your microbial data, reducing risk, building efficiency and improving your bottom line, while assisting in the journey to bring products to market.
Expert View: Annex 1 updates: The impact of microbial ID strategy on cleanroom qualifications for pharma manufacturers
Dr Lucia Ceresa discusses the importance of accurate microbial IDs for cleanroom performance qualification and the risks of inaccuracies or failures.