Celsis Advance II™ High-Throughput Rapid Microbial Detection System
Principle: Provides high throughput ATP bioluminescence rapid microbiology detection
Automation: Yes
Approvals: FDA 21 CFR Part 11, EU Annex 11
Suitability: Microbial contamination testing for sterility, in-process, bioburden, and microbial limits
Description:
Key Points:
The Celsis Advance II instrument provides a high-throughput ATP bioluminescence rapid microbiology detection solution that has helped companies worldwide screen products for microbial contamination. It offers an exceptionally high throughput of up to 120 assays per hour, supporting large-scale manufacturing operations by delivering results in less than 48 hours for microbial limits USP (<61>) and 6 days for sterility testing (USP <71>).
Key Points:
- Amplified ATP Bioluminescence
- 120 samples per hour
- Application: Microbial contamination testing for sterility, in-process, bioburden, and microbial limits. Preserves standard sample preparation methods for both membrane filtration and direct inoculation. Compatible with standard pharmaceutical APIs, biologics, vaccines, cellular and gene therapy products, ATMPs, opaque, viscous, and complex product formulations.
- FDA 21 CFR Part 11, EU Annex 11, FDA Drug Master File on Record
Areas:
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Company contact details:
Charles River Microbial Solutions view full details
Wilmington
United States
Website: Visit Website
Tel: +[1] 877 274 8371
Charles River Microbial Solutions view full details
Wilmington
United States
Website: Visit Website
Tel: +[1] 877 274 8371