Cleanroom Testing
Cleanroom Testing & Certification
Cleanroom Testing & Certification to Ensure Compliance, Validate Air Quality, Protect Products & Support Operational Performance
Benefits of Cleanroom Testing & Certification
SET3 delivers expert testing and certification for pharmaceutical, semiconductor,
aerospace, and mission-critical cleanrooms, ensuring alignment with the latest FDA, ISO,
USP, and IEST standards. Whether you're preparing for regulatory audit, commissioning a
new cleanroom, or validating ongoing compliance, our certified technicians bring 27+ years
of proven precision to every test.
Deliverables Include:
ISO/FDA/USP-Compliant Certification Reports
Digital Particle Count Logs
Deviation Risk Assessment Summaries
Custom Recommendations for Ongoing Compliance
Why Clients Choose SET3
Certified, experienced field teams
Fast-turn documentation with traceability
Clear compliance path with FDA & ISO integration
Optional retesting, annual tracking, and validation support
INDUSTRIES WE SERVE
Essential Testing Procedures for Cleanroom Certification & Environmental Assurance
Services include environmental reports detailing pre and post clean test results, along with recommendations for increasing environmental effectiveness.
Semiconductor & Electronics
ISO 14644-1/-2/-3/-8/-9 Compliance
IEST RP-CC001.7:2022 Filter Protocols
AMC Testing
Temperature, Humidity, and ESD Checks
Optional Vibration and Surface Cleanliness Audits
Pharmaceutical & Life Sciences
USP <797> / <800> Compliant
FDA 21 CFR Part 211 (cGMP for Drugs)
ISO 14644-1:2015 & ISO 14644-3:2019
Integrating ISO 13408-1:2024 aseptic processing requirements
Services:
• Particle Count Testing (Semi-Annual)
• HEPA Filter Integrity Testing
• Airflow Volume & Velocity Mapping
• Pressure Differential Validation
• Viable Air & Surface Sampling
• Smoke Visualization Studies
Aerospace & Precision Manufacturing
AS9100D-aligned protocols
ISO 14644-3 Airflow and Pressurization Testing
Surface Cleanliness Monitoring (ISO 14644-9:2022)
Environmental Stability & Material Compatibility Testing
Medical Devices & Specialized Facilities
ISO 13485:2016
FDA 21 CFR Part 820 QSR Integration
Routine and Risk-Based Requalification
Clean Build and Start-Up Support
Having unsolved microbial hot spot Issues? Can’t find a contamination source?
SET3 Testing Protocols Aligned With
| Standard | Latest Version | Purpose |
|---|---|---|
| ISO 14644-1 | 2015 | Cleanroom classification (particle counts) |
| ISO 14644-2 | 2015 | Ongoing monitoring requirements |
| ISO 14644-3 | 2019 | Test methods: HEPA, airflow, pressure |
| ISO 14644-8 | 2022 | Chemical contamination limits |
| ISO 14644-9 | 2022 | Surface particle cleanliness |
| USP <797> / <800> | 2023 | Sterile and hazardous drug handling |
| ISO 13408-1 | 2024 | Aseptic processing (globally adopted) |
| IEST RP-CC001.7 | 2022 | HEPA/ULPA filter testing protocol |
Talk TO A Pro
Over 75% of cleanroom failures are linked to environmental issues. Ask us how our consulting and testing services can help resolve contamination risks and support compliance.
Contact Us
How Can We Help?
We provide services across the United States, the United Kingdom, and the Asia Pacific rim. Contact us today to find out how we can bring you peace of mind, money savings, and experienced consulting for your critical environment needs. Our online contact form was built to handle a wide variety of requests to better serve you. Please complete the contact form, and we will contact you shortly regarding your needs.
Your benefits:
- Regulatory Compliance
- Contamination Control
- Product Integrity
- Operational Efficiency
- Employee Safety
- Maximum Uptime
What happens next?
1
We review your inquiry and assign a case specialist.
2
We schedule an introductory call at your convenience.
3
We evaluate your needs and determine next steps.