USP 797 – Pace Analytical

The Importance of Trending in USP Compliance

The Importance of Trending in USP <797> Compliance

Analytical + Environmental / Rhonda Lintner

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USP 797 FAQs: Positive and Negative Controls

Analytical + Environmental / Rhonda Lintner

At its essence, USP <797> is a quality control (QC) standard used to protect patients from contamination that can occur when pharmacies produce compounded sterile preparations (CSPs). Media-fill, gloved fingertip, surface sampling, and other tests are used to confirm personnel competency and ensure bioburden control of compounding areas and personnel. For these results to be valid,

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USP <797> Q&A: Cleanroom Requirements

Analytical + Environmental / Rhonda Lintner

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USP <797> Q&A: Sampling Pass-Throughs

Analytical + Environmental / Rhonda Lintner

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USP Q&A Do I need to have a microbiologist on staff?

USP <797> Q&A: Do I need to have a microbiologist on staff?

Analytical + Environmental / Rhonda Lintner

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USP Compliance It's as Easy as A, B, C,..1, 2, 3, Or is it?

USP <797> Compliance: It’s as Easy as A,B,C…1,2,3. Or is it?

Analytical + Environmental / Rhonda Lintner

USP Compliance: It’s as Easy as A,B,C…1,2,3. Or is it? Read More »

Demonstrating USP Surface Sampling Competency

Demonstrating USP <797> Surface Sampling Competency

Analytical + Environmental / Rhonda Lintner

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USP 797 FAQs: Media Kits

Analytical + Environmental / Rhonda Lintner

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

Analytical + Environmental / Rhonda Lintner

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

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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

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