Rapid Bioburden and Sterility Testing Special Focus

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25th September 2023 Content supplied by: various sources as indicated

Rapid Bioburden and Sterility Testing - a rapidmicrobiology Special Focus

Charles River Sterility testing solutions

Achieving faster product release is essential for short shelf life products such as personalised therapies, but increasingly all QC labs face pressure to get quicker product release, with more traceability and fewer qualified staff, all while being compendial compliant. In this rapidmicrobiology special focus, you can access various resources to help achieve your goals.

From the Charles River website, download Paul Newby's eBook "Guidance on Implementation of Alternative and Rapid Methods", which outlines the process stages, technical, business, and data integrity issues to be addressed in implementing ARMM (Alternative and Rapid Microbiological Methods) technologies for use in the development, in-process control, and commercial release of drug products.

Learn from Lamin Jallow, Microbiology Technology Specialist for the Life Science business of Merck, about the challenges that labs are facing with the implementation of RMMs for bioburden and sterility testing and his experience with implementing RMM, particularly for cell and gene therapies.

How to handle those difficult samples that just won't filter? Nils Jäger, Application Scientist, Sartorius Lab Instruments, and Juliane Großmann, Product Manager, Sartorius Lab Instruments, share their in-depth knowledge and experience of how best to achieve accurate microbiological results for viscous liquids. Download the Sartorius application note to ensure compliant filtration of viscous samples.

For ultra-fast results, there's bioMérieux's ultra-rapid SCANRDI^®, delivering results in just 4 hours, also on offer is the BACT/ALERT^® system that works with complex matrices.

Red One™, based on cutting-edge Solid Phase Cytometry technology, uses advanced image processing to detect viable cells with highly reliable differentiation of viable cells from inert particles,

Visit the Alternative and Rapid Methods Conference at PharmaLab 2023, where representatives and experts from industry and laboratories will discuss with you the current requirements and their experiences in implementation.

Incorporating Quality Control Technologies in the Lab

Whilst fully understanding the benefits of alternative and rapid microbiological methods, microbiologists tasked with their implementation can find it hard to know where to begin. Charles River is there to support with a wealth of resources, including this practical guideline, which is free to download.
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The Challenge of Implementing Rapid Methods for Bioburden and Sterility Testing

In this rapidmicrobiology interview Lamin Jallow, Microbiology Technology Specialist for the Life Science business of Merck, discusses the challenges that laboratories encounter when implementing rapid microbiological methods for bioburden and sterility testing.
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How to Achieve Pharmacopeia-Compliant Bioburden Testing of Viscous Samples

Viscous samples place distinct demands on each component of a filtration system. Learn from Sartorius Lab Instruments filtration experts how best to achieve accurate microbiological results for viscous liquids.
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MICA Bioburden: 24h to 48h for Comprehensive Microbial Detection

Revolutionize your microorganisms detection with Diamidex's MICA Advance Bioburden. Enumerate all microorganisms in water within just 24 or 48 hours of incubation.
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Ensuring Pharmaceutical Quality: The Essential Role of Rapid Sterility and Bioburden Testing

Rapid sterility and bioburden tests are major components of the pharmaceutical strategy. Unlike traditional methods, rapid sterility testing ensures safe releases, curbing contamination risks and helping to deliver safe, quality treatments to patients.
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Reliability in your Microbiological QC for All Biomanufacturing Steps

Quality Control in biopharmaceuticals is vital to ensure the quality and safety of a product. Condalab has the required culture media to perform MFT, Sterility Testing, and Non-Sterile Products Testing without complications.
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Still on the Move - Alternative and Rapid Microbiological Methods

Demonstrating comparability with the compendial methods, as well as validation, was often more difficult than anticipated, and regulators were often unfamiliar with such changes. Today, more than 15 years later, we are still on the way At the Alternative and Rapid Methods Conference at PharmaLab 2023
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Detect Microbial Contaminants Earlier

The Milliflex^® Rapid 2.0 system helps to improve process control and product yield while bringing forward end product release. It is compatible with a variety of filterable samples in the pharmaceutical, ATMP, biotech and personal care industries.
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Red One™ Rapid Bioburden Testing in 4 Hours, Sterility in 4 Days

A fully automated system for rapid detection of microbial contaminations: Red One™ delivers faster results than traditional methods, allowing more rapid confirmation of pharmaceutical product quality and quicker product release.
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Automated Detection System for Early Detection of Microbial Contamination in Filtrable Samples

Back by popular demand, the Milliflex^® Rapid 2.0 system automatically detects, images, and quantifies viable microbial contaminants in filterable samples throughout the manufacturing process. Delivering results up to 4x faster, it is the ideal solution for sterility and bioburden testing.
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