Biomedical
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ISO/IEC 17025:2017 accredited cleanroom certification per ISO 14644-1/2/3 — particle counting, HEPA/ULPA integrity testing, airflow visualization, pressure-cascade verification, and recovery testing · ANAB Certificate AC-1736
To find ISO/IEC 17025 accredited cleanroom calibration services for particle counters, air velocity meters, differential pressure gauges, and HEPA filter testers in the United States, contact an ANAB-accredited laboratory like Techmaster Electronics, LLC (cert AC-1736) — founded 1989, with five accredited US labs serving semiconductor fabs, pharmaceutical manufacturing, medical device manufacturing, and aerospace assembly.
ANAB ACCREDITED · CERT AC-1736 · VALID THROUGH 2026-10-29
Techmaster Electronics provides ISO/IEC 17025:2017 accredited cleanroom certification and re-certification per ISO 14644-1, 14644-2, and 14644-3 for pharmaceutical, semiconductor, biotech, medical-device, and aerospace customers. From particle counts and HEPA/ULPA filter integrity testing to airflow visualization, pressure cascade, and recovery studies, our ANAB-accredited engineers deliver documented controlled-environment qualification that meets USP 797/800, FDA QSR, GMP Annex 1, and SEMI cleanroom requirements across the United States.
Our biomedical calibration capabilities cover the most widely used IEC 60601-2-X compliant patient simulators, electrical safety analyzers, and clinical engineering test equipment. Each unit is calibrated against NIST-traceable standards with full uncertainty reporting included.
Handheld and portable laser particle counters (0.1–10 μm) for ISO 14644-1 cleanroom classification and routine viable / non-viable particle monitoring across pharma, semi, biotech, and medical-device facilities.
Hot-wire, vane, and thermal anemometers plus capture-hood balometers for HEPA face-velocity, airflow uniformity, and air-change-rate verification per ISO 14644-3.
High-accuracy differential and absolute pressure instruments for cleanroom pressure-cascade qualification, isolator monitoring, and HEPA filter ΔP verification.
TDA-2i, ATI-2i, and equivalent aerosol photometers for HEPA / ULPA filter leak and integrity testing per IEST-RP-CC034 and IEST-RP-CC001.
Also calibrated: Thermohygrometers · Light Meters · Sound Level Meters · Air Velocity Meters · Smoke / Visualization Generators · Microbial Air Samplers · Digital Tachometers · Surface Particle Monitors · Stopwatches · TOC Analyzers
Controlled-environment certification for the regulated industries where contamination control, particle classification, and HEPA-filter integrity are non-negotiable for product quality, patient safety, and yield.
USP 797/800 sterile compounding pharmacies, FDA-regulated drug-product fill/finish lines, isolator and RABS suites under GMP Annex 1.
ISO 5 / Class 100 wafer-fab clean tunnels, photolithography bays, EUV maintenance enclosures, and MEMS assembly lines.
GMP Annex 1 Grade A/B bioprocessing, autologous CGT cleanrooms, AAV manufacturing, and viral-vector fill/finish.
USP 800 hazardous-drug suites, OR compounding hoods, sterile processing departments, and endoscope reprocessing rooms.
Satellite payload integration bays, optical-assembly cleanrooms, propulsion-fluid cleanliness, and ITAR-controlled production.
FDA QSR / ISO 13485 device assembly, sterile-barrier packaging, implant production, IV catheter and dialysis cartridge mfg.
Aseptic packaging lines, infant-formula production, sterile dairy fill, dietary supplement and probiotic manufacturing.
University and national-lab nanofabrication cleanrooms, advanced-materials research, and quantum-device clean enclosures.
Every Techmaster calibration includes a calibration sticker on the instrument. Choose the documentation level that matches your audit, regulatory, or quality program needs.
Click here to learn more about our three calibration levels →
Why pharma, semiconductor, biotech, aerospace, and hospital sterile-processing teams trust Techmaster for cleanroom certification and contamination-control test equipment calibration since 1989.
ANAB Cert AC-1736 — full uncertainty budgets, NIST-traceable standards, and audit-ready documentation on every report.
Particle-counter classification, HEPA leak testing, airflow uniformity, and pressure cascade verified per ISO 14644-1/2/3 and IEST-RP-CC001/CC034 — at our ANAB-accredited US labs.
Standard 5-business-day turnaround with 1–2 day expedite available. Free local pickup in Silicon Valley, So-Cal, and Orlando.
Our cleanroom engineers handle ISO 14644 re-certifications, USP 797/800 qualifications, isolator and RABS validation, and one-off facility commissioning that other labs decline. Send us your room class, dimensions, and HEPA count for a same-day scoping quote.
Common questions about ISO 14644 cleanroom certification and controlled-environment testing at Techmaster Electronics.
Send us your room dimensions, ISO class target, and HEPA / ULPA count and we’ll respond within one business day with pricing, scheduling, and a scope-of-work proposal.