Comprehensive evaluation of Growth Direct® Rapid Sterility for microorganism detection
29 May 2024
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Discover the extensive panel testing done to evaluate the new, innovative sterility testing platform, Growth Direct® Rapid Sterility.
Watch this on-demand webinar now
Current Rapid Sterility methods have been unable to deliver truly rapid sterility results across a large panel of challenge organisms. The Growth Direct® Rapid Sterility (GDRS) system has set out to fulfil the promise of a true rapid sterility testing method across a large, diverse and challenging organism panel based on the pharmacopeia, industry literature and global pharmaceutical manufacturer’s challenge panels.
By growing the extensive panel of organisms during challenge testing, we demonstrate that GDRS provides rapid results without compromising patient safety. For example, traditional slow growing organisms, such as C.Acnes, were detected in only 56 hours and a time-to-result was shown to be only 72 hours, highlighting the incredible speed of GDRS.
Benefits of the GDRS system
GDRS is an alternative rapid, membrane filtration based test designed to deliver a time to result in as little as t-3 days and a time to detect in as little as 12 hours. It allows pharmaceutical manufacturers to quickly respond to contaminations with real-time notifications, reduces their risk by automating processes and maintains their test integrity with a closed-loop design. You’ll increase productivity, enhance data security with automation and release safe products quickly.
Overcome your existing challenges through several design parameters and results:
- Consumable design optimized for aerobic bacteria, anaerobic bacteria, yeast, and mould
- Developing a comprehensive challenge organism panel
- Stressing bugs
- Direct inoculation side by side
- Vision core technology
- Time-to-Detect (TTD) data
- Time-to-Result (TTR) data
OUR SPEAKER
Kayla Volis – R&D Microbiologist, Rapid Micro Biosystems
Kayla is an R&D Microbiologist for Rapid Micro Biosystems specializing in sterility testing automation. She has successfully assisted in scaling up pharmaceutical manufacturing and supported various continuous improvement projects. Kayla earned a B.S. degree in Biotechnology from Northeastern University.
KEY LEARNING POINTS
- How to approach challenge microorganism panels in the selection of a rapid testing method
- Effectiveness of detection using the Growth Direct Rapid Sterility system
- How to stress microorganisms in a manner that is commonly accepted in the industry
- Validating alternative microorganism rapid sterility media
FAQs
Is the webinar free?
Yes – there is no charge to watch the webinar, either live or on-demand.
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.