Pharmacies that prepare individualized dosages of sterile drugs for patients must meet stringent requirements and standards to assure patient safety. Our FDA-licensed products and cGMP-compliant services for compounding pharmacists help maintain control, consistency, and reduce risks associated with manufacturing in an aseptic environment.
Robust QC Microbial Testing Strategies for a Compliant Compounding Operation
This webinar breaks down what sterile compounders need to know to strengthen microbial QC testing strategies. It covers which methods support compliance, how to weigh the decision to insource or outsource testing, and what pitfalls to avoid when building or evaluating your contamination control plan. It also showcases real-world examples from across the compounding space, offering practical lessons in balancing regulatory expectations with operational constraints. Watch Webinar Replay
Sterility testing is designed to demonstrate the presence or absence of extraneous viable contaminating microorganisms in biological parenterals designed for human use.
The sterility test is applied to substances, preparations or articles, which, according to the United States Pharmacopeia (USP) and European Pharmacopoeia (EP), are required to be sterile. Sterility testing is used for bulk and final drug products, cell banks and raw materials.
WEBINAR ON-DEMAND
See how Pharmetric replaced the standard 14-day traditional sterility test with a 6-day rapid sterility test, and significantly improved processes and eliminated days of incubation.
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Sterility Testing Products & Services
- Rapid Sterility Testing In-house Solutions
- Sterility Testing Services
- Drug Product Release
- Mycoplasma Testing
Our collaboration with the Charles River team was instrumental in seamlessly validating and implementing the Celsis technology. Their expertise ensured that we met rigorous compendial standards and established a reliable framework for routine testing, reinforcing our commitment to excellence in pharmaceutical quality.”
Philip Smith, Director of Laboratory Services, Fagron Sterile Services
The Bacterial Endotoxins Test (BET) detects unsafe levels of microbial cell wall debris, from live or dead Gram-negative bacteria, that cause fever or septic shock.
CASE STUDY
Fagron Sterile Services Relies on Charles River for Critical QC Testing
Learn how Fagron Sterile Services uses Endosafe® rapid bacterial endotoxin testing and Accugenix® microbial identification to reduce human error and increase operational efficiency. Download Case Study
Traditional methods of the BET require skilled analysts and manipulation of cumbersome reagents. Our endotoxin testing systems provide faster results for improved process efficiency and ease-of-use over traditional methods while offering additional benefits of portability, improved accuracy, and reproducibility.
The Endosafe® nexgen-PTS™ yields quantitative endotoxin results in approximately 15 minutes, which translates into fewer bottlenecks and faster production, improved sample management, and the assurance that your products are free of endotoxin (pyrogen) within limits set by the United States Pharmacopeia (USP).
Bacterial Endotoxin Testing Products & Services
Did you know that Accugenix® services consistently provide results with a >99% on-time delivery rate? With same day, one day, two day, and five day turnaround times, we offer the flexibility you require in choosing the test that fits your needs.
CASE STUDY
Environmental Monitoring Matters: Going Beyond the USP <797> Standard
Learn why going beyond minimum recommendations for
Data gathered from a well-designed and executed EM program provide critical information for tracking and trending on a routine basis. Accurate and consistent species-level identifications help demonstrate a state of control in your manufacturing environment which is critical for regulatory compliance.
Microbial Identification Services
Related Resources
• Achieving 503A+: JSD Pharmacy Sets the Gold Standard for Super Sterile – Case Study
• Microbial Identification: How to Comply with the Current and Future Versions of USP Chapter <797> –Webinar
Charles River delivers client-focused solutions for the testing and manufacturing of biologics according to international regulatory guidelines.
With the most comprehensive biologics testing portfolio in the industry, we offer protocols to meet global regulatory requirements. From biosafety testing and impurity detection to potency determination and lot release programs, our team of scientists and project managers ensures that the most appropriate methods are used for your product.
Biologics Products & Services
Microbial Services
| Advancing Health by Supporting Safe Pharmaceutical Compounding – Case Study |
| USP Changes Directly Impacts Compounding Pharmacies – Blog |
Bacterial Endotoxin Testing
| Fagron Sterile Services Relies on Charles River for Critical QC Testing – Case Study |
Sterility Testing
Microbial Identification
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