Insights

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...

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...

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...