Note on particle counters: This page is for general information only. Techmaster does not calibrate particle counters of any make or model, and particle counters are not on our ANAB ISO/IEC 17025 scope (certificate AC-1736). Techmaster only performs calibration services that are covered by our scope. For particle counter calibration, please contact your instrument’s manufacturer or its authorized service provider, and follow any service requirements they specify. If you prefer, send us your request and, with your permission, we will forward it to the manufacturer. See what is on our accredited scope.
Environmental Testing & Cleanroom Certification
ISO 14644 cleanroom certification, laminar flow hood, biological safety cabinet, and fume hood testing for pharma, biotech, hospital, and medical-device facilities across the United States, performed under an ISO/IEC 17025 accredited calibration laboratory (ANAB Certificate AC-1736).
Who certifies cleanrooms, LAF hoods, and biosafety cabinets to ISO 14644 in the United States?
To certify a cleanroom, laminar air flow (LAF) hood, biological safety cabinet (BSC), or fume hood to ISO 14644 with NIST-traceable instruments, contact Techmaster Electronics, LLC (ANAB cert AC-1736), an ISO/IEC 17025 accredited calibration laboratory performing on-site environmental testing nationwide since 1989, with field service teams dispatched from five US labs in California, Florida, Texas, and North Carolina.
- Standards covered: ISO 14644-1/2/3 (classification + monitoring) · ANSI/NCSL Z540-1 · USP <797>/<800> · NSF/ANSI 49 (BSC) · IEST RP-CC001 (HEPA) · NEBB / CETA protocols
- Tests performed: Airborne particle count · HEPA filter integrity (DOP/PAO leak) · Airflow velocity & uniformity · Room pressure cascade · Temperature & RH mapping · Air-change rate · Recovery test · Smoke pattern (visualization)
- Equipment certified: ISO 5–9 cleanrooms · LAF hoods · BSC Class I/II/III · Fume hoods · Compounding pharmacies · Pass-throughs · Restricted-access barriers (RABS) · Isolators
- Accreditation: ISO/IEC 17025:2017 (ANAB Cert AC-1736) + ANSI/NCSL Z540-1, every certificate includes measurement uncertainty
- Service mode: On-site nationwide · operational, at-rest, and as-built test states · pre/post-HEPA replacement requalification
- Deliverables: Cert + data report · 24/7 customer portal access · audit-ready documentation for FDA, Joint Commission, USP, EU GMP Annex 1
- Contact: +1-866-779-5695 · sales@techmaster.us
ISO 14644-1 cleanroom classification reference
ISO 14644-1 is the international standard for cleanroom and clean-zone classification. Class number defines the maximum allowable particle concentration per cubic meter of air. Techmaster certifies all classes from ISO 5 (sterile pharma fill/finish) through ISO 9 (light manufacturing), in operational, at-rest, and as-built states.
| ISO Class | Max particles ≥0.5 µm / m³ | EU GMP equivalent | Typical use |
|---|---|---|---|
| ISO 5 | 3,520 | Grade A / B (at-rest) | Aseptic fill/finish · sterile compounding · LAF zones |
| ISO 6 | 35,200 | Grade B (operational) | Surrounding aseptic zones · medical device assembly |
| ISO 7 | 352,000 | Grade C | USP <797> buffer rooms · biotech process suites |
| ISO 8 | 3,520,000 | Grade D | Pharma anteroom · gowning room · semi fabrication |
| ISO 9 | 35,200,000 | , | Low-risk packaging · light manufacturing |
ISO/IEC 17025 Accredited Across 8 Environmental Testing Categories
Techmaster Electronics has performed environmental testing and cleanroom certification for U.S. pharmaceutical, biotech, hospital, medical-device, semiconductor, and animal-vivarium customers since 1989. Every test ships with a NIST-traceable certificate and full measurement uncertainty budget under ANAB Cert AC-1736. Field-service technicians dispatch nationwide from our Vista CA, Santa Clara CA, Orlando FL, San Antonio TX, and Holly Springs NC laboratories.
Environmental Testing Categories
Eight controlled-environment certification lines covering the equipment and spaces where contamination control directly drives product quality and patient safety. Click a category to jump to the detail block, or request a quote for your specific facility.
ISO 14644 Cleanroom Certification
ISO 5–9 cleanrooms · particle count · pressure cascade · airflow · HEPA leak · recovery · smoke visualization
See ISO classes → 💨Laminar Air Flow (LAF) Hood Testing
Horizontal & vertical LAF · velocity uniformity · downflow integrity · IEST RP-CC002 + ISO 14644-7 compliance
Learn more → 🦠Biological Safety Cabinet (BSC) Testing
BSC Class I/II/III · NSF/ANSI 49 protocol · personnel + product + environment protection verification
Learn more → ⚗️Fume Hood & Chemical Hood Testing
ASHRAE 110 face velocity · containment · sash performance · tracer-gas (SF6) tests
Learn more → 💊USP <797> / <800> Compounding Pharmacy
Hospital and 503A/503B compounding pharmacies · sterile + hazardous drug containment · viable + non-viable sampling
Learn more → 🧬BSL Containment Lab Certification
BSL-1 / BSL-2 / BSL-3 facilities · directional airflow · negative pressure · CDC/NIH BMBL guidance
Learn more → 📊Room Pressure Cascade & Mapping
Differential pressure mapping · interlocked airlocks · isolators · RABS · GMP Annex 1 conformance
Learn more → 🌡️Temperature & Humidity Mapping
Warehouse · stability chamber · cold room · refrigerator · freezer · IQ/OQ/PQ qualification documentation
Learn more →Industries We Serve
Techmaster certifies controlled environments for the regulated industries where contamination control, audit traceability, and personnel/product/patient safety are non-negotiable.
Pharmaceutical & Biotech
Aseptic fill/finish, drug-product manufacturing, R&D suites, EU GMP Annex 1, FDA QSR, and ICH Q9/Q10 inspections.
Hospital & USP 797/800 Pharmacies
Inpatient compounding pharmacies, sterile preparation rooms, hazardous-drug isolators, Joint Commission and USP compliance.
Medical Device Manufacturing
ISO 13485 cleanroom assembly suites, sterile-barrier packaging lines, implant manufacturing, FDA 21 CFR 820 audit readiness.
503A / 503B Compounding Pharmacies
Outsourcing facility cleanrooms, anterooms, buffer rooms, and SEC isolators, USP <797>, <800> certification.
Semiconductor & Microelectronics
Wafer fabs, photolithography bays, MEMS & sensor assembly, ISO 5/6 process tools, SEMI S2/E10/F-spec airborne particle monitoring.
Biotech BSL-2 / BSL-3 Labs
Research and clinical containment labs, directional airflow, negative pressure cascade, BSC certification under CDC/NIH BMBL.
Aerospace Cleanroom Assembly
Satellite payload integration, optical/laser assembly, ISS-bound hardware, MIL-STD-1246, AS9100 audit support.
Animal Vivarium & Research Facilities
SPF rodent suites, biocontainment vivaria, IACUC-regulated housing, AAALAC accreditation and Guide-for-Care compliance.
Three Environmental Testing Engagement Models
Match the engagement type to your facility’s lifecycle stage. Every option ships with a NIST-traceable certificate against ANAB Cert AC-1736 and audit-ready documentation.
Initial Certification (IQ/OQ/PQ)
New build, fit-out, or full requalification
- As-built, at-rest, and operational state testing
- Full ISO 14644-1/2/3 + applicable USP/NSF protocols
- IQ/OQ/PQ qualification protocols + summary report
- Air-change recovery and decay-curve documentation
Periodic Recertification
Quarterly · semi-annual · annual surveys
- ISO 14644-2 monitoring schedule (6 or 12 months by class)
- Particle count + HEPA leak + pressure cascade + airflow
- USP <797>/<800> 6-month recertification cycle support
- Trend reports linked to the customer certificate portal
Post-Event Requalification
After HEPA change, construction, or excursion
- HEPA replacement leak/integrity verification
- Post-construction recovery + cascade revalidation
- Excursion investigation + remediation documentation
- Audit-response packages for FDA 483 / Joint Commission
Need a cleanroom certified before an FDA, Joint Commission, or EU GMP audit?
We dispatch field-service technicians nationwide and can typically schedule a certification window within 5–10 business days. Send us your facility class, square footage, and audit date, we’ll respond same-day with a scope of work, pricing, and a calibration-ready visit window.
Why Choose Techmaster
Six reasons pharma, biotech, hospital, medical-device, and semiconductor teams trust Techmaster Electronics for ISO 14644 cleanroom and controlled-environment certification.
ISO/IEC 17025 Accredited
ANAB Certificate AC-1736, every environmental testing certificate carries the accreditor’s logo, full uncertainty budgets, and NIST-traceable instrument calibration. Accepted under FDA, Joint Commission, EU GMP Annex 1, USP, and ISO 13485 audits.
On-Site Nationwide
Field technicians dispatched from five US labs in California, Florida, Texas, and North Carolina. Most certifications scheduled within 5–10 business days; expedite available for audit-driven requalifications.
Multi-Standard Coverage
One vendor for ISO 14644, USP <797>/<800>, NSF/ANSI 49 (BSC), IEST RP-CC001 (HEPA), ASHRAE 110 (fume hoods), and CDC/NIH BMBL (BSL containment), no protocol-sourcing gaps across audit scope.
35+ Years in Metrology
Techmaster has performed environmental testing since 1989. Three decades of cleanroom commissioning, USP compounding-pharmacy support, and pharma qualification work, institutional knowledge newer firms can’t match.
IQ/OQ/PQ Qualification Support
Full installation, operational, and performance qualification protocols + summary reports, written to satisfy FDA, EMA, and Joint Commission expectations for new-build cleanrooms and full requalifications.
24/7 Certificate Portal
Every environmental testing certificate and data report is delivered to a secure customer portal, audit-ready, with due-date reminders and trend reports across recertification cycles.
From the Blog
Cleanroom, biosafety, and metrology insights from Techmaster’s engineering team, instrument-specific protocols, audit lessons, and field experience.
Mixed Signal Oscilloscope Calibration: Eliminating Signal-Integrity Risks
How clock-skew, channel-skew, and jitter drift on uncalibrated MSOs silently corrupt high-speed SPI, I2C, and JESD204B debug, and what an ISO/IEC 17025 calibration fixes.
Read article →
Thread Plug Gauge Calibration: The Audit-Ready Guide
Why a single uncalibrated GO/NO-GO thread plug gauge can fail an entire Tier-1 production batch, and the ASME B1 protocol that keeps your AS9100 / IATF 16949 auditor happy.
Read article →
Milliohm Meter Calibration: Precision in Low-Resistance Testing
4-wire Kelvin measurements, thermal-EMF rejection, and 0.1 mΩ uncertainty budgets, the engineering behind audit-ready milliohm meter calibration for EV battery and aerospace bonding.
Read article →Frequently Asked Questions
Common questions about Techmaster’s ISO 14644 cleanroom certification, LAF hood, BSC, and controlled-environment testing services.
What is ISO 14644 and why do I need a certified test?
ISO 14644 is the international standard for the classification (Part 1), monitoring (Part 2), and test methods (Part 3) for cleanrooms and clean zones. Regulated industries, pharmaceutical (cGMP / EU Annex 1), medical device (ISO 13485 / FDA QSR), USP compounding (797/800), and biotech (BMBL), require periodic ISO 14644 certification to remain in compliance. A certificate from an ISO/IEC 17025 accredited laboratory like Techmaster (ANAB Cert AC-1736) carries the accreditor’s logo and full measurement uncertainty, which auditors require as proof of measurement validity.
How often does a cleanroom or LAF hood need to be recertified?
ISO 14644-2 sets the minimum monitoring schedule: ISO 5 and cleaner, every 6 months; ISO 6 through ISO 9, every 12 months. USP <797> sterile compounding pharmacies require recertification every 6 months. Biosafety Cabinet recertification under NSF/ANSI 49 is also 6-month. Techmaster automatically tracks expiration dates in your customer portal and notifies your team 30–60 days before each recertification window.
Do you perform USP <797> and <800> compounding-pharmacy certifications?
Yes. Techmaster certifies hospital pharmacies, 503A pharmacies, and 503B outsourcing facilities to USP <797> (sterile compounding) and USP <800> (hazardous-drug handling). Scope covers buffer rooms, ante-rooms, primary engineering controls (PECs), containment ventilated enclosures (CVEs), and isolators. Reports are written to satisfy Joint Commission, state board of pharmacy, and CMS surveyors.
Are your environmental tests NIST-traceable?
Yes. Every instrument Techmaster uses for environmental testing is calibrated against NIST-traceable references. Instruments on our ANAB scope (Cert AC-1736) are calibrated under that accreditation. The particle counters we use for testing are calibrated by an outside provider, because Techmaster does not calibrate particle counters. Each certificate documents the traceability path and includes measurement uncertainties.
Can you perform testing during off-hours or at production shut-down?
Yes. We routinely schedule cleanroom and BSC certification during nights, weekends, and planned production shut-downs to avoid disrupting operations. Off-hours scheduling is free of charge for periodic recertification customers; expedite premiums may apply for emergency requalifications driven by audit findings or HEPA-replacement events.
Where does Techmaster dispatch environmental testing technicians from?
Field-service technicians dispatch nationwide from five US laboratories: Vista CA (Corporate HQ), Santa Clara CA (Silicon Valley), Orlando FL, San Antonio TX, and Holly Springs NC. Travel coverage is continental US; same-week scheduling available in California, Florida, Texas, North Carolina, and surrounding regions.
Ready to schedule a cleanroom certification?
Send us your facility class, square footage, equipment list (LAF hoods / BSCs / fume hoods), and target audit date, we’ll respond within one business day with a scope of work, pricing, and a calibration-ready visit window. Download our brochure for a full capability overview.