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.
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.
Sterility Testing Products & 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.
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 and 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.
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.
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