USP 797 – Pace Analytical

USP <797> Personnel Competency Q&A

Building Sciences / Rhonda Lintner, MPH, B.S.

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. Watch On-Demand: USP <797> Personnel Competency and Environmental Monitoring After the formal presentation, Michael and Rhonda answered numerous practical questions from attendees. In addition, we received several more […]

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Demonstrating USP Surface Sampling Competency

Demonstrating USP <797> Surface Sampling Competency

Building Sciences / Rhonda Lintner, MPH, B.S.

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

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USP <797> FAQs: Media Kits

Building Sciences / Rhonda Lintner, MPH, B.S.

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. Q: Can you tell me which media kits I should use? A: Although Pace® supplies

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10 Tips for Proper Shipping of USP <797> Samples

Building Sciences / Rhonda Lintner, MPH, B.S.

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. 1. Label samples on the bottom or base of

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USP 797 BUDs: How the 2023 Changes Impact Environmental Monitoring Requirements

Analytical + Environmental / Manju Pradeep

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. For more information

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