Pharmacies that prepare individualized dosages of sterile drugs for patients must meet stringent requirements and standards to assure patient safety. Charles River offers comprehensive microbial testing solutions for compounding pharmacists to help maintain control and reduce risks associated with manufacturing in an aseptic environment.

    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).

    Related Products and Services
    Endosafe® nexgen-PTS™
    Contract Testing Services
    LAL Reagents & Accessories

Products & Services

    Did you know that Accugenix® services consistently provide results with a >99% on-time delivery rate? No matter the requested turnaround time, 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 result in more confidence in the control of your environment.

    Axcess® System

Related Resources »

Products & Services

    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.

Products & Services

    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.

Related Resources »