Compounding Pharmacy

Pharmacies that prepare individualized dosages of sterile, high-risk drugs for patients must meet stringent requirements and standards to assure patient safety. Charles River offers comprehensive quality microbial solutions to ensure the safe manufacture and timely release of your products.

Webinar: Establishing a Microbial QC Program

We discuss the importance of establishing a microbial ID program and bacterial endotoxin testing to ensure product safety. Download the webinar

 

Bacterial Endotoxins Test (BET) detects unsafe levels of microbial cell wall debris, from live or dead Gram-negative bacteria, that cause fever and symptoms of septic shock. Until now, the BET required skilled analysts and manipulation of cumbersome reagents.

The Endosafe® -PTS yields a 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 Pharmacopeia.

Charles River offers accurate and consistent microbial identification methods that are critical in managing risk by yielding comprehensive and reliable data for tracking and trending during routine monitoring of and investigations into excursions. 

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Sterility Testing

Charles River can partner with you in all phases of drug development to help ensure that your materials are contaminant free.

Contamination and Impurity Detection

Whether faced with critical timelines or stringent regulations, you can rely on Charles River to ensure the safe manufacture and timely release of your product.