USP <797> & <800> Compliance: Why PEC Certification is Critical for Your Cleanroom
Ensure Sterility, Safety, and Compliance with Primary Engineering Control (PEC) Certification
Why is PEC Certification Essential for USP <797> & <800> Compliance?
Primary Engineering Control (PEC) Certification is a mandatory process that ensures sterile compounding environments comply with USP <797> and USP <800>. Whether you’re operating a cleanroom, pharmacy, or hospital compounding lab, maintaining ISO Class 5 air quality is critical to patient safety and regulatory compliance.
Key Benefits of PEC Certification:
- ✅ Compliance with USP <797>, <800>, and FDA regulations
- ✅ Protection against contamination and hazardous drug exposure
- ✅ Ensures HEPA filters and airflow systems function properly
- ✅ Pass Joint Commission inspections effortlessly
- ✅ Increased safety for pharmacists, patients, and staff
Primary Engineering Control (PEC) Certification: What’s Included?
At Medical Testing Solutions, our expert team performs comprehensive PEC testing to ensure your facility meets compliance standards.
✔ HEPA Filter Integrity Testing
We verify that your HEPA filters are fully intact and effectively filtering airborne contaminants, maintaining ISO Class 5 conditions.
✔ Airflow Velocity & Volume Testing
We test airflow rates to ensure laminar flow hoods (LAFWs), biological safety cabinets (BSCs), and compounding aseptic isolators (CAIs) are working properly.
✔ Airflow Visualization (Smoke Study)
Our smoke testing analysis ensures unidirectional airflow patterns, preventing cross-contamination in sterile compounding areas.
✔ Particle Count Testing
We measure airborne particle levels to confirm ISO Class 5 compliance, ensuring a sterile environment.
✔ Viable Air & Surface Sampling
Using microbial sampling, we assess contamination risks to prevent bacterial growth in your PEC.
✔ Pressure Differential Testing (For USP <800> Facilities)
For hazardous drug handling, we ensure negative pressure containment to protect personnel and product integrity.
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Who Needs PEC Certification?
PEC certification is required for any facility that compounds sterile medications, including:
- 🏥 Hospitals & Healthcare Facilities
- ⚕️ Compounding Pharmacies
- 🧪 Research Laboratories & Cleanrooms
- 💊 Pharmaceutical Manufacturing Plants
How Often is PEC Certification Required?
Under USP <797> and <800>, PECs must be tested and certified every six months or after maintenance, repairs, or relocation.
Get Your Facility Certified Today!
Our trained professionals ensure full compliance with industry regulations.