USP 797 Environmental Monitoring
Comprehensive sample culture and analysis services to help compounding pharmacies, hospitals, and healthcare providers maintain USP 797 compliance and ensure patient safety.
What Is USP 797?
USP 797 is a set of guidelines established by the United States Pharmacopeia (USP) to ensure the safety and quality of compounded sterile preparations (CSPs). These standards cover personnel training, environmental monitoring, quality control procedures, and documentation requirements.
By adhering to USP 797 standards, healthcare facilities minimize the risk of contamination, enhance patient safety, and ensure the potency of compounded medications. The latest standards became official on November 1, 2023, further minimizing the risk of environmental contamination.
Compliance Areas We Support
Viable Surface Sampling
Bacterial and fungal counts to genus level using TSA and SabDex contact plates, ensuring cleanroom surfaces meet USP 797 standards.
Viable Air Sampling
Bacterial and fungal air quality monitoring using TSA and SabDex petri plates to verify controlled environment compliance.
Gloved Fingertip Testing
Bacterial and fungal culture with counts using TSA petri plates to verify aseptic technique of compounding personnel.
Media Fill Analysis
Sterility competency testing with complete kits including sterile bags, vials, tryptic soy broth, and syringes.
Aseptic Competency Testing
Comprehensive evaluation of personnel aseptic technique to ensure compliance with USP 797 training requirements.
Cleanroom Certification
Testing and certification services for cleanrooms, biosafety cabinets, fume hoods, laminar flow hoods, and compounding isolators.
USP 797 Environmental Testing Requirements
| Matrix | Analysis | Supplies |
|---|---|---|
| Air | Bacterial & fungal counts to genus level | TSA petri plates or contact plates; SabDex petri plates or contact plates |
| Surface | Bacterial & fungal counts to genus level | TSA contact plates, 15x65mm; SabDex contact plates, 15x65mm |
| Gloved Fingertip | Bacterial & fungal culture with counts | TSA petri plates, 15x100mm |
| Media Fill | Sterility competency for media fill | Empty sterile bags & vials, sterile tryptic soy broth, syringes |
Why Choose Air Allergen for USP 797 Testing?
- ISO/IEC 17025:2017 certified laboratory with AI-powered reporting for faster, more accurate results
- Same-day processing for samples received by 12pm EST
- Competitive pricing with configurable sampling kit subscriptions
- Expert guidance on compliance requirements and remediation strategies
- Complete sampling kits with all materials needed for surface, fingertip, and media fill testing
Get Started with USP 797 Compliance Testing
Contact our team to discuss your facility's environmental monitoring needs and receive a customized testing plan.