Process Validation
Additionally, all compounded products are tested for potency, sterility, particles, and endotoxins prior to their distribution. This ensures our customers receive products free from contaminants at the proper strength.
In accordance with existing guidance documents, the personnel at Apollo Care complete media-fills every six months. These procedures are designed to mimic worst-case scenario to validate aseptic performance and the implementation of cleanroom procedures.
All cleanroom staff at Apollo Care are required to pass the sleeve and the gloved fingertip bioburden monitoring tests three times upon hire and every six months to participate in any cleanroom activities.
To learn more about these processes, please see the links below: