Testing of Rapid Microbiological Methods (RMMs) – Demonstrating Equivalence to Existing Methods in Alignment with USP <1223>
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26 June 2024
3:00pm
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Join this webinar to hear about the latest RMM technology and how it aligns with UPS <1223> testing criteria. This webinar will cover testing strategy, and data will be presented to effectively demonstrate suitability of the Soleil for its intended use and correlation to plate counts.
Register your details to secure a place.
This webinar outlines how the Sievers Soleil microorganism verification testing aligns with United States Pharmacopeia <1223> “Validation of Alternative Microbiological Methods.” It compares results to traditional agar plating methods, assessing against criteria in USP <61>, <62>, European Pharmacopoeia 2.6.12, 2.6.13, and Japanese Pharmacopoeia 4.05 for nonsterile product microbial examination.
The testing criteria evaluated include range, linearity, accuracy, reproducibility, robustness, precision, limits of quantitation/detection, and ruggedness. This webinar session demonstrates correlation of Soleil’s Total Viable Cell counts to colony forming units (CFU) on agar plates, with data reported in comparable CFU units.
Key learning points:
- Explore at-line rapid microbial method designed to monitor bioburden at ultrapure levels with results in less than 45 minutes
- Discover how RMMs allow users to quickly and easily monitor bioburden levels throughout the manufacturing process, from raw materials to in-process samples to final product, alleviating risks and improving operations
- Understand how to design a meaningful testing programme in alignment with USP <1223>
- Learn how the Sievers Soleil overcomes challenges related to implementation of RMMs and effectively meets criteria from USP <1223> and other guidance.
Register today!
OUR SPEAKERS
Cort Lawrence, Lead Researcher – Microbiology
Cort Lawrence is a Lead Microbiology Researcher at Veolia Water Technologies & Solutions. He graduated with his Bachelor of Science in Microbiology from the University of Arizona in 2016. Since then Cort has worked in varying capacities as a microbiology subject matter expert.
Meg Provenzano, Global Product Manager- Bio Detection
Meg Provenzano is the Product Manager for Sievers bio-detection instruments at Veolia Water Technologies & Solutions. She has over 10 years of experience in the bacterial endotoxin testing industry and has held several positions in Quality Control, Technical Support, and Product Management. She is customer-centric and enjoys hands-on problem solving, whether for technical issues, assay assistance, or software. Meg holds a BS in Marine Science and Biology from Coastal Carolina University where she focused on Bottlenose Dolphin population research.
FAQs
FAQs
Is the webinar free?
Yes – there is no charge to watch the webinar, either live or on-demand.
When will the webinar take place?
26 June 2024 at 4.00pm GMT.
Can I watch it later?
The webinar will become available to watch on-demand shortly after the live webinar takes place.
What are the benefits of attending live?
You’ll be able to ask the speakers your questions, which will be answered live in the Q&A towards the end of the session.
How long will the webinar be?
This webinar will last up to an hour.
What do I need to watch this webinar?
All you need is a computer with an internet connection. We recommend using headphones if possible if you’re in an office environment.
