We are pleased to announce two new RMM validation packages, Celsis® Complete and Celsis® Advantage, allowing QC micro labs to completely outsource validation testing or by receiving ready-to-use protocols to streamline their own in-house validation.
As the pharmaceutical and biotechnology industries continue to expand, demanding more efficient biomanufacturing processes, the need for rapid, alternative testing methods continues to grow, especially for final product sterility testing. However, many on-market rapid microbial detection methods have not yet been successful in meeting this need, largely due to the fact that many are either inefficient in operation, incompatible with too many product types, or incapable of being validated against the compendial test method.
In this product spotlight, you will learn:
- The Celsis® instrument product line and how Celsis AMPiScreen® works
- How the Celsis® assay complies with USP 71, Eu Ph 5.1.6, and other traditional sterility testing procedures
- Pre-qualified Sartorius Sterisart NF sterility test canisters designed purposely design with rapid detection testing in mind
- Pre-qualified TSB and FTM media, compliant with USP formulae, manufactured for lot-to-lot consistency by Hardy Diagnostics
- How our new validation service bundles, Celsis® Complete and Celsis® Advantage, can save more than 6 months in validation time and costs
Watch the product spotlight to learn how these solutions are just what the industry has been waiting for.