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30th July 2024 Content supplied by: Rapid Micro Biosystems
Comprehensive Evaluation of Growth Direct® Rapid Sterility for Microorganism Detection
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 in 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 (TTR) in as little as 1-3 days and a time to detect (TTD) in as little as 12 hours. It allows pharmaceutical manufacturers to quickly respond to contamination events with real-time notifications, reduces risk by automating processes, and maintains test integrity with a closed-loop design. Manufacturers are able to increase productivity, enhance data security with automation, and release safe products quickly.
Unique advantages:
- Consumable design optimized for aerobic bacteria, anaerobic bacteria, yeast, and mold
- Validated using a comprehensive challenge organism panel including stressed and slow growing organisms
- Direct inoculation
- Non-destructive vision core technology
- Time-to-Detect (TTD) in as little as 12 hours
- Time-to-Result (TTR) in as little as 1-3 days
If you have additional questions about automating rapid microbial detection and enumeration for your QC microbiology, visit Rapid Micro Biosystems or click on the Request Information button below to contact us.
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Date Published: 30th July 2024
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