The revisions took effect in November 2023
To help ensure you’ve got everything covered, we’ve created this guide to be your go-to resource for all USP Chapter <797> changes related to environmental monitoring. Environmental monitoring is required at least every 6 months, including routine surface and air sampling. Monthly testing may be required depending on the compounding category and applicable regulations.
Everything you need to know! We cover a wide range of topics including:
USP <797> BUD: Categories of Compounded Sterile Preparations (CSPs)
Cleanroom Classifications
Garbing & Gloved Fingertip Sampling
Viable Air Sampling & Viable Surface Sampling Requirements
Choosing a Lab Partner
Media-Fill Testing
Documentation & Training
Checklist for Creating an Environmental Monitoring Plan
Ordering Supplies & Proper Shipping and Handling of Samples
Do's and Don'ts - and more!