Knowledge Category: Regulatory
Quality by Design and Single-Use Air Sampling Approaches FAQ
This FAQ paper is a follow up to the webinar, āQuality by Design and Single-Use Air Sampling Approachesā. Many thoughtful questions were asked about the future of viable air monitoring. Questions submitted during and after the webinar are answered in the paper.
Paper
USP 797 Guidelines for Viable Non-Viable Monitoring
According to USP 797 guidelines, critical areas must continuously meet ISO Class 5 or better conditions for 0.5 Ī¼m particles, and must exclude microbial contamination during the compounding of CSP’s. These classifications ensure that a designated zone is maintained in a clean state. The monitoring program is designed based on contamination risk to finished product quality.
