Accommodations for Leak Testing HEPA Filters
USP Chapter 797 (2019) Section 5 establishes the minimum requirements for the certification of ISO classified...
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Development of a Strategic Relationship with Facilities-Maintenance/ Outside Contractors for Interaction with Controlled
The following report is to discuss the concerns and complications along with the actions to take...
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Pass-Through Options for Sterile Compounding Facilities
Materials must be moved into and out of cleanrooms in a manner that reduces transfer of...
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LAFW Observations
What's wrong with this picture? The HEPA filter is stained with overspray from the compounding operation.....
Read MoreClients Compliant by Nov. 2023 in USP Chapters <795> & <797>
USP Chapters were released on November 1, 2022. They become enforceable on Nov. 1, 2023. We have been proactively preparing for these changes. We will continue to communicate with our valued clients to ensure seamless preparation for your compounding facilities to remain compliant, Stay tuned for more information!