
Clean Room Certifications
Ensure Compliance. Protect Patients. Maintain Sterility.
In pharmaceutical and compounding environments, clean room certification isn’t just a requirement—it’s a commitment to safety, compliance, and product integrity. At HPI, we specialize in clean room certification for pharmacies operating under USP <797>, USP <800>, and cGMP standards.
🔍 What We Certify
We offer full certification services for:
ISO-Classified Clean Rooms (ISO 5–8)
USP <797> Sterile Compounding Areas
USP <800> Hazardous Drug Rooms
Positive/Negative Pressure Rooms
Segregated Compounding Spaces
All work is performed using calibrated equipment and documented to meet ISO 14644, USP <797>/<800>, and FDA standards.
🧰 What’s Included in Certification
Our clean room testing includes:
HEPA Filter Integrity Testing (PAO / DOP)
Airflow Velocity and Volume Testing
Pressure Differential Monitoring
Non-Viable and Viable Particle Counts
Airflow Visualization (Smoke Testing)
Temperature and Humidity Monitoring
Surface Sampling (optional per protocol)
✅ Fully documented for inspections and audits
🛡️ Why Choose HPI?
USP <797> / <800> Compliant Procedures
Trained, Certified Technicians
Responsive Scheduling
Detailed Reports with Pass/Fail Results
Trusted by Hospitals, Pharmacies, and Labs
📆 Ready to Schedule?
Contact Us
Service@histologyPartners.com
1-813-291-3344
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