Setra Blog


July 15, 2022

FDA 21 CFR Part 11, Predicate Rules and Environmental Monitoring

 

Continue Reading →

March 03, 2022

Monitoring Compounding Pharmacies with Setra CEMS

The quality of compounded medications, and therefore patient safety, is a critical concern for compounding pharmacies. Pharmacies performing compounded sterile preparations (CSPs) must meet specific cleanroom standards like those outlined in USP 797 and USP 800 to ensure sterile conditions and the quality of CSPs are maintained. As such, it is crucial environmental parameters stay within specified limits.

Continue Reading →