USP Chapters <795> and <797> have been in limbo since the appeals process delayed the anticipated December 2019 official revision implementation date. On March 11, 2020, USP announced that multiple appeals dealing with Beyond Use Dates (BUD) have been combined into one announcement. A...
USP Chapter 797 (2019) Section 5 establishes the minimum requirements for the certification of ISO classified areas. Section 5 references the Controlled Environment Testing Association’s (CETA) certification guide for Sterile Compounding Facilities for specific procedures. Section 5 also lists HEPA filter Integrity Testing as...
The following report is to discuss the concerns and complications along with the actions to take when dealing with controlled environment facility-related issues. Pharmacy is responsible to demonstrate a continuous “State of Control” over their sterile compounding facility. General: Facility/maintenance staff must not work...
Materials must be moved into and out of cleanrooms in a manner that reduces transfer of particulate contamination into the ISO classified suite.Sealed double-door pass-through boxes are often used as a convenient and efficient means of transferring directly from the buffer room to an...
What's wrong with this picture? The HEPA filter is stained with overspray from the compounding operation. While there are no tests that a certifier will conduct that tend to demonstrate that this staining is problematic, the FDA has made it clear through their...
