Microchem Laboratory Now Offering Comprehensive Sterility Assurance Testing
After months of internal validation work and various refinements, Microchem is excited to formally announce the latest expansion of our testing services: Sterility Testing for pharmaceuticals and medical devices.
Sterility testing is a crucial step in the manufacturing process for pharmaceuticals and medical devices, ensuring products are free from any viable microorganisms. This includes bacteria, fungi, and spores, all of which pose serious health risks if present in drugs and medical devices intended to be sterile.
To ensure test integrity, all sterility testing is conducted within an ISO Class 5 laminar flow hood within in our state-of-the-art cleanroom.
Sterility Test Method:
- USP <71>: Expertly conducted in our state-of-the-art cleanroom, this test ensures that products are free from viable contaminating microorganisms.
This exciting addition adds to our rapidly expanding GMP test portfolio, including recent additions of over-the-counter (OTC) drug and dietary supplement testing. Microchem is committed to providing a full spectrum of product quality testing services to our clients.
For more information about sterility testing, please contact Allan Aguilar, Sterility Assurance Project Manager.
