USP 797: Personnel Sterile Preparations and Compounding
USP 797 is a set of guidelines established by the United States Pharmacopeia (USP) to ensure the quality, safety, and efficacy of compounded sterile preparations (CSPs) in healthcare settings. It specifically focuses on personnel responsibilities and requirements for maintaining a sterile environment during the compounding process.
- Personnel Sterile Preparations/Competency: Demonstrates the capability of compounding personnel and aseptic processes in maintaining sterility during the preparation of sterile products.
- Media Fill Test (Aseptic Process Simulation)
- Gloved Fingertip Test (Competency Evaluation)
- Environmental Monitoring: Regular monitoring of the compounding environment to assess and control microbial contamination risk, including air quality, surface contamination, and personnel gowning.
- Viable Air Samples – Microbial (Fungal/Bacterial) Enumeration and Identification (Agar Plate)
- Viable Surface Samples – Microbial Enumeration and Identification (Contact Plate & Swab)
- Media Growth Promotion/Sterility Testing.
- Sterility Testing: Confirms the sterility of compounded preparations by testing for the presence of viable microorganisms.
- Product Flush
- Membrane filtration
- Monthly Viable Surface Sampling Kits: Self-Sampling kit subscription for monthly viable samples (USP 797 2023 regulatory frequency changes). Shipping and organism Identifications (*If above action levels) are included with the quoted price, please contact us to receive a personalized quote.
Self-Sampling Kit Includes:
- Sterile Agar Contact Plates
- Sterile Sample Bag
- Easy-to-Follow Instructions
- Labels
- Organisms Identifications*