USP 797 & 800 Cleanroom Certification
Protect patients, staff, and your accreditation with comprehensive PEC certification — ensuring your cleanroom meets every USP, FDA, and Joint Commission requirement.
- AIHA-accredited lab
- ≤24-hour reports
- 0% audit failure rate since 2018
Get a quote in 1 business day
The Cost of Non-Compliance Is Catastrophic
48% of facilities fail first-time USP <800> inspections. Don't become a statistic.
FDA shutdown orders
Immediate facility closure for non-compliant compounding areas
$25k+ daily fines
State and federal penalties for operating without valid certification
Loss of accreditation
Joint Commission and CMS accreditation at risk without current testing
Patient safety liability
Contaminated compounded medications can cause serious harm or death
Speed
Full certification reports delivered in ≤24 hours
Precision
0% audit failure rate since 2018
Support
24/7 compliance hotline with direct engineer access
Hospitals & Health Systems
Sterile compounding cleanroom certification for hospital pharmacies and central sterile processing departments.
Compounding Pharmacies
503A and 503B compounding facility PEC and SEC certification for USP <797> and <800> compliance.
Research Labs & Cleanrooms
ISO-classified cleanroom testing for pharmaceutical research laboratories and manufacturing environments.
Hazardous Drug Handling
USP <800> negative pressure containment verification to protect staff handling hazardous drugs.
Why Choose Medical Testing Solutions for USP 797 & 800 Certification
Primary Engineering Control (PEC) certification is a mandatory process that ensures sterile compounding environments comply with USP <797> and USP <800>. Whether you operate a hospital pharmacy, compounding facility, or research laboratory, maintaining ISO Class 5 air quality is critical to patient safety, staff protection, and regulatory compliance. Medical Testing Solutions has certified hundreds of cleanrooms and compounding facilities across the nation with a 0% audit failure rate.
- Full USP <797> and <800> cleanroom certification
- HEPA filter integrity testing (DOP/PAO method)
- ISO Class 5 through Class 8 particle count verification
- Viable air and surface sampling for microbial contamination
- Pressure differential mapping and monitoring
- Airflow velocity, volume, and smoke visualization studies
- 24-hour turnaround available for urgent needs
- Nationwide coverage — all 50 states
82% faster than our 24-hour service commitment.
Request a Quote
Tell us about your cleanroom certification needs and we'll provide a custom quote.
PEC Certification Testing Checklist
Our certified technicians perform every test required by USP <797> and <800> to ensure your cleanroom and PECs meet compliance standards.
The Certification Process
From initial assessment to final documentation — we make USP compliance straightforward.
Particle Counts
ISO Class 5–8 verification per ISO 14644
Viable Sampling
CFU/m³ air and surface analysis
Pressure Mapping
Differential pressure between all rooms
Surface Testing
Contact plate and swab sampling
Documentation
Full report package delivered in ≤24hrs
Need Cleanroom Certification?
24-hour turnaround available. Our certified technicians ensure your facility meets every USP, FDA, and Joint Commission requirement.
Craftsmanship Warranty Included
Every service is backed by our craftsmanship warranty — we stand behind our work.
Frequently Asked Questions
Explore Our Other Services
Medical Testing Solutions provides a complete range of medical gas services nationwide.
Medical Gas Verification
ASSE 6030 verification for new installs & renovations
Annual Inspections
ASSE 6040 annual compliance inspections
Medical Gas Installation
ASSE 6010 certified pipeline installation
Medical Gas Maintenance
Preventative maintenance & emergency repairs
Medical Gas Training
ASSE 6010–6040 certification courses
Line Isolation Monitor Testing
NFPA 99 LIM testing & calibration
Dental Flowmeter Repair
$950 flat-rate repair & NIST calibration
WAG & Chemical Vapor Monitoring
AIHA-accredited monitoring badges & lab analysis
Chemical Exposure Monitoring
N₂O, formaldehyde, glutaraldehyde/OPA & O₂ deficiency testing
Industries We Serve
Hospitals, ASCs, dental, veterinary, dermatology & more
All Medical Gas Services
Complete service overview & hub page
Need USP 797 & 800 Cleanroom Certification?
Our certified technicians are ready to ensure your compounding facility meets every USP, FDA, and Joint Commission requirement. Call now or request a free quote.
ASSE 6010 · 6020 · 6030 · 6040 Certified | Bonded & Insured | SAM/DUNS Registered