news
Determining accurate estimation of true endotoxin concentration
Research suggests that performing LAL gel clot tests and narrowing the dilution range can provide good estimation of endotoxin concentration in pharmaceuticals.
List view / Grid view
Environmental Monitoring
article
The power of rapid methods for fungal ID
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.
news
ISO publishes standard on bacterial endotoxin testing
Evaluation of bacterial endotoxin pyrogens is included in the International Organization for Standardization (ISO)’s new standard for microbiological methods.
article
In Depth Focus QA/QC Microbiology/RMM 2023
This in-depth focus explores collaborative efforts to accelerate validation and adoption of rapid microbial methods across the pharmaceutical industry and the power of rapid methods for fungal ID.
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Reflecting on five years of quality control for nitrosamine impurities
Since the US Food and Drug Administration (FDA)’s report on a series of nitrosamine-related impurity drug recalls in 2018, pharma has made great strides in its ability to detect and control for these impurities. Dr Mrunal Jaywant, Vice President of R&D at USP India proposed a collaborative, cross-community approach between…
video
Webinar: How crucial is culture media selection in environmental monitoring? A roundtable discussion
A roundtable panel discusses culture media regulatory requirements and how media specifications could impact your environmental monitoring program in aseptic manufacturing.
whitepaper
Case study: Eliminating contamination with whole genome sequencing
Read this case study to learn how a pharmaceutical company used Accugenix Whole Genome Sequencing for bacterial and fungal ID.
news
Why is microbiological testing in medical device manufacturing important?
Careful planning during manufacture means accurate microbiology testing methods can be developed, ensuring the safety and efficacy of medical devices, a paper reports.
podcasts
EPR Podcast 19 – Collaboration in microbiology – Allison Scott, Lynn Johnson and Miriam Guest, M³ Collaboration
In this podcast, Allison Scott, Lynn Johnson and Miriam Guest discuss how cross-industry collaboration through working groups can support adoption of modern microbial methods.
webinar
Strategies for implementing eConsent across the European regulatory landscape
30 May 2023 | By Medable
In this webinar, we dive into the intricacies of implementing electronic informed consent (eConsent) in clinical trials within the complex regulatory landscape of European countries.
whitepaper
Application note: Enhancing microbial monitoring with an online bioburden analyser
A data-driven approach to optimise sanitisation and improve process control of the microbial parameter in a water system.
article
Guide To Testing
In this edition, experts from Institute of Biomedical Research Antoine Marxer and Associates of Cape Cod International share insight on endotoxin testing.
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European Pharmaceutical Review Issue 2 2023
EPR Issue 2 includes articles on the future of cell and gene therapy, the potential of AAV gene therapies, NMR relaxometry and more…
webinar
The hidden costs of microbial misidentifications
20 April 2023 | By Charles River Laboratories
Doug Botkin, PhD, examines the challenges and consequences of inaccurate microbial identification methods using real-world case studies and discusses how these challenges can be addressed.
news
Identifying origin of fungi in cleanrooms
Microbiology expert Tim Sandle’s recent video examined identifying the origin of fungi in pharmaceutical cleanrooms.
