- Supports manufacturing of single-use healthcare products with alternative method capabilities using non-animal derived reagents in bacterial endotoxin testing
- Complements existing microbiological and product and package testing services offered at Brooklyn Park, MN
January 10, 2025 – As part of our long-term commitment to supporting global healthcare product manufacturing, STERIS is pleased to announce our Brooklyn Park, Minnesota, USA laboratory now offers a sustainable approach to bacterial endotoxin testing through the use of recombinant cascade reagents.
Our bacterial endotoxin service furthers our commitment to supporting sustainable service solutions to medical device manufacturers throughout all stages of the sterilization design process. Using this approach, recombinant reagents mimic the natural reaction to endotoxins in the horseshoe crab immune system, allowing for endotoxin detection without using animal-derived components. As a critical piece of product development, this sustainable offering ensures that products meet industry requirements outlined in the proposed addition of chapter <86> in USP, ISO 11737-3 and AAMI/ANSI ST72.
At STERIS, we support our Customers with qualified laboratory equipment used to validate bacterial endotoxin testing using recombinant reagents, guidance on Customer qualifications, and regulatory support during FDA submission.
In conjunction with the microbial validation and product and package testing services offered by STERIS, the bacterial endotoxin testing services using recombinant endotoxin reagents provide a comprehensive portfolio of testing options for the validation of sterile medical devices. Product release to market is further supported by the STERIS AST global network of contract irradiation and gas sterilization facilities.
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About STERIS
STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services. For more information, visit www.steris.com.
