Category: Insights

[vc_row][vc_column][vc_btn title="Click Here to Download PDF" link="url:https%3A%2F%2Fcenvironment.com%2Fwp-content%2Fuploads%2F2024%2F02%2FINSIGHTS-Pass-through-Options-Jan-2024.pdf||target:%20_blank|"][vc_column_text]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...

[vc_row][vc_column][vc_btn title="Click Here to Download PDF" link="url:https%3A%2F%2Fcenvironment.com%2Fwp-content%2Fuploads%2F2020%2F02%2FAccomodations-for-Leak-Testing-HEPA-Filters-02.10.2020.pdf||target:%20_blank|"][vc_column_text]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...

[vc_row][vc_column][vc_btn title="Click Here to Download PDF" link="url:https%3A%2F%2Fcenvironment.com%2Fwp-content%2Fuploads%2F2019%2F11%2FINSIGHTS-Development-of-Facilities-Protocol-for-Interaction-with-Controlled-Environments-1.pdf||target:%20_blank|"][vc_column_text]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...

[vc_row content_placement="middle"][vc_column width="1/2"][vc_btn title="Click Here to Download PDF" align="left" link="url:https%3A%2F%2Fcenvironment.com%2Fwp-content%2Fuploads%2F2019%2F09%2FLAFW-Observations-12_2018-Website-Resource-06.19.19.pdf||target:%20_blank|"][vc_column_text]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...