EP monographs allow rFC for water testing
As of 1 April, two European Pharmacopoeia monographs allow the use of rFC to test for bacterial endotoxins in pharmaceutical waters.
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As of 1 April, two European Pharmacopoeia monographs allow the use of rFC to test for bacterial endotoxins in pharmaceutical waters.
This report is dedicated to exploring some of the latest advances in pharmaceutical environmental monitoring, covering topics from contamination control and cleanroom validation through to emerging technologies for bacterial endotoxin testing.
The new sterilisation method could provide an affordable, rapid approach for preparing microbiological culture media, research suggests.
Revisions for two proposed USP chapters recommend changes for rapid tests required for releasing sterile short-life products, as well as for rapid microbiological methods (RMM) for detecting contamination in these products.
In this Q&A, Natalie Saunders, Interim Head of Quality Control at CGT Catapult, delves into the advancements and challenges in microbiological QC for cell and gene therapies. She discusses rapid sterility testing methods, regulatory frameworks, and the impact of automation and digitalisation on quality control.
A new 24-hour sterility testing method combining nanopore sequencing and machine learning could revolutionise sterility assurance in biopharmaceutical manufacturing of cell therapies.
Sterility testing is a critical component of release testing for any cell therapy product since microbial contamination of cell therapy products can potentially kill recipients.
Address the importance of accurate microbial identifications and proper contamination control for effective mold remediation.
This microbiology in-depth focus, explores sterility and bioburden testing considerations for cell and gene therapies.
EPR Issue 5 includes articles on microbiological testing of ATMPs, the use of inline Raman spectroscopy for bioprocess control, paediatric drug formulation, and more.
Research using fluorescent optical respirometry (FOR) illustrated successful detection of aerobic bacteria three hours after setting samples.
13 September 2023 | By Veolia Water Technologies & Solutions, Sievers Instruments
Learn how Rapid Microbiological Methods can provide results in less than 45 minutes and endotoxin assays can be set up in less than 10 minutes to improve contamination control and reduce risk.
In this Q&A, Laure Pomares Voisin, Quality Director, Catalent Biologics and Tony Cundell Principal Consultant, Microbiological Consulting, LLC discuss some of the key microbiology and environmental monitoring challenges and trends in pharmaceutical manufacturing today.
The pharma industry’s adaptation to Industry 4.0 has been slow, due to the extensive regulatory requirements imposed on manufacturers. However, regulatory agencies are starting to embrace movement towards more rapid/automated systems, as illustrated in the revised EU GMP Annex 1, which entered into force in August. Here, Isabella Jul-Jørgensen from the Technical…
By leveraging rapid identification techniques, pharmaceutical facilities can enhance their ability to detect and mitigate fungal contamination, safeguarding product quality and patient safety. Here, Dr Tim Sandle explores key challenges associated with fungal contamination in cleanrooms, discusses conventional and rapid identification methods, as well as the importance of validation.