The standards are intended to apply to all persons who prepare compounding sterile preparations (CSP’s) and all places where CSP’s are prepared. Compliance requirements depend on the type of ISO Designation the facility operates. USP 797 requires the following testing as part of the certification process:
- Non-viable particulate measurement
- Viable Sampling-Air and Surface
- Temperature and Relative Humidity
SRP Environmental utilizes an American Industrial Hygiene Association (AIHA)-accredited laboratory for all analyses. State-of-the-art equipment is used for the sample collection and measurement.