With compounding pharmacy regulations under scrutiny, compliance has never been more important. Maintain control and consistency in your compounding procedures with solutions from Charles River. Offering unmatched regulatory expertise and a portfolio of FDA-licensed products and cGMP-compliant services, Charles River is the trusted partner who can help you align your operations with current regulatory standards.
Rapid Endotoxin Testing of Compounded Sterile Products with the
Endosafe® nexgen-PTS™
- Handheld spectrophotometer utilizing FDA-licensed LAL cartridges
- Compatible with suitable dilutions of all common CSP drugs
- No need to prepare endotoxin standards
- No microbiology training required
- Quantitative endotoxin results in 15 minutes
Accugenix®
Microbial Identification for Environmental Monitoring
- FDA-registered, cGMP-compliant contract testing lab
- Bacterial and fungal identification and strain typing of environmental isolates
- DNA sequence-based and MALDI-TOF technologies
- Reference libraries with over 10,000 relevant species
- Tracking and trending data management tool to manage samples and investigations
- Flexible turnaround time options ranging from same-day to five days for final report delivery
Rapid Sterility and Microbial Limits Testing with Celsis
®
Rapid Detection Systems
- Shortens the traditional 14-day sterility incubation period to 7-days and eliminates the subjectivity of visual turbidity confirmation with an ATP-based bioluminescence automated analysis
- Reduces the long incubation times necessary for a quantitative assay with a qualitative, presence/absence result for confident contamination detection.
- Allows full compliance with 21 CFR Part 11 and the European Union's Annex 11
- Click to start: enjoy walkaway automation
CONTACT US
P: 877.CRIVER1 (877.274.8371) |
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