Environmental monitoring, specifically viable sampling, is a key metric of the state of control of your compounding area, indicating the performance of your engineering controls, efficacy of your cleaning processes, and competency of your personnel.Through the proposed revisions to USP <797>, the USP Compounding Expert Committee has signaled an expectation to increase the frequency of viable sampling to ensure the quality of the compounding environment.
In this webinar, Abby Roth CMQ/OE, Owner/Microbiologist at Pure Microbiology and Simplifi 797 compliance expert Annie Lambert, PharmD, BCSCP, will provide an overview of the USP standards and present options for meeting proposed compliance standards including considerations for sample collection, equipment, and microbiologic interpretation of results. At the conclusion of the webinar, you will be able to:
- Describe the current and proposed USP <797> requirements for air and surface sampling in compounding areas.
- Compare and contrast options for meeting compliance standards, including in-sourcing and out-sourcing various elements of the sampling process.
- Assess compliance in your organization and develop an action plan to meet proposed standards when they are implemented.