USP 797 / 800 Compliance
Supporting Compounding Pharmacies in Maintaining Sterile, Compliant Workspaces
Zenith Laboratories assists compounding facilities in meeting USP 797 and USP 800 regulatory requirements through personnel qualification, environmental monitoring, and self-sampling solutions.
Analyses Offered:
Media Fill Test (Aseptic Process Simulation) – Demonstrates aseptic handling competency through growth media transfer simulation.
Gloved Fingertip Test (Competency Evaluation) – Enumeration of viable colonies from gloved fingertips to assess aseptic skill.
Surface Sampling Competency (Enverify Kits) – Personnel surface sampling kits to verify proficiency and maintain compliance.
Routine viable monitoring of compounding environments to ensure controlled conditions.
Analyses Offered:
Viable Air Sampling (Agar Plates) – Enumeration and identification of airborne bacteria and fungi.
Viable Surface Sampling (Contact Plates or Swabs) – Enumeration and identification of surface microorganisms.
Media Growth Promotion & Sterility Verification – Ensures media used in environmental monitoring are viable and effective.
Subscription-based self-sampling kits to support monthly testing requirements under USP 797 (2023 update).
Kit Includes:
Sterile Agar Contact Plates
Sterile Sample Bag
Easy-to-Follow Instructions
Labels
Microorganism Identification (if above action levels)
