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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?