Insight and Perspective
A Q&A by Deborah Ensign, Shawn Sherry, and Kate Bloomrose Microtest Labs.
The U.S. Food and Drug Administration has in place very specific clean room standards, which must be adhered to by producers of sterile drug products. With an array of clean room variables such as surfaces, disinfectants used, and organisms, no one disinfectant or disinfectant protocol can be a precise fit. It is the direct responsibility of the manufacturer to maintain an acceptable level of sterility. To ensure an adequate level of control, disinfectant qualification studies are necessary.
From the tests performed to the data generated, this Q&A examines all of the steps in a qualification study and provides in-depth knowledge by Microtest experts.