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In our USP <797> Q&A Series, we’ve mentioned cleanrooms a few times but haven’t gone too deeply into the topic. As in other areas, the revised USP <797> standard includes a few changes. Some tighten up the requirements, while others leave things open to interpretation. Here are answers to some of the more frequent questions we get on USP <797> cleanroom standards.
In this series of Q&A posts, we’re answering questions from customers about USP <797> compliance. Some of these are common questions. Others, not so much. All are important.
If you have questions about how to comply with the latest revisions to USP <797>, you’re not alone. Even though the standard has been in effect since November of 2023, we’re still getting a lot of foundational questions about specific requirements.
Aspergillus, Bacillus, and Cladosporium – The Importance of Genus Identification
On September 18, Dr. Michael Berg, Technical Director Pace® Building Sciences, and Rhonda Lintner, Pace® Account Executive, presented a webinar on the USP <797> Personnel Competency requirements.
In 2023, the USP <797> standard for compounded sterile preparations was significantly revised to improve patient safety. Not only are there more protocols to follow, but pharmacies may need to demonstrate their adherence to USP <797> to various Authorities Having Jurisdiction (AHJ). Proving adherence includes documenting standard operating procedures (SOPs), but it also includes providing ample evidence that these SOPs are followed and effective.
Lately, the Pace® microbiology team has been fielding a lot of questions on how to interpret and implement different aspects of the revised USP <797> standard. Here are some of the most frequently asked questions regarding the use of sampling media kits.
The 2023 revisions to USP <797> increase compliance requirements for compounding pharmacies. Following proper handling and shipping procedures for lab media can help ensure all that extra effort doesn’t go to waste. Here are ten tips for ensuring your gloved fingertip and surface samples arrive safely.
In November 2023, significant revisions to the United States Pharmacopeia (USP) General Chapter <797> will go into effect, bringing critical updates to the environmental monitoring standards governing the compounding of sterile preparations. In this post, we delve into the changes to USP 797 BUD standards and how they impact environmental testing requirements.
