Christian Provost

By: Christian Provost

|

Jan 25, 2025

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.

Need a PEC Certification for Your Facility?

Ensure compliance and patient safety today! Contact our experts for a free consultation.
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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.

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