Particle Counter Calibration Delivers Reliable Data Every Time

May 21, 2025

Particle counter calibration is critical for industries like pharmaceuticals, semiconductors, and aerospace, where even a single airborne particle can cause batch failure or regulatory non-compliance. With over 30 years of expertise, Techmaster Electronics delivers calibration services that ensure cleanroom integrity and ISO audit readiness.

What Is a Particle Counter and Why Calibration Matters

A particle counter measures airborne or fluid-based particulate matter. These devices are commonly used in cleanrooms to ensure contamination levels remain within regulated limits.

Handheld particle counter in cleanroom use
Portable particle counter used for air monitoring

Industries that Rely on Particle Counter Calibration

  • Pharmaceuticals & Biotech – Ensuring sterility in GMP-compliant manufacturing

  • Semiconductors & Electronics – Preventing microscopic defects in sensitive components

  • Aerospace & Medical Devices – Meeting safety-critical precision standards

  • Food Processing – Maintaining hygiene for consumer safety

Without routine particle counter calibration, devices can drift, leading to non-compliance with ISO 21501-4, GMP, or FDA requirements.

Why Particle Counter Calibration Is Essential for Compliance

Regular calibration prevents:

  • Inaccurate measurements that lead to failed audits

  • Regulatory breaches and the risk of losing ISO/GMP certifications

  • Operational downtime, batch rejections, or product recalls

  • Loss of customer trust due to quality lapses

Techmaster’s ISO/IEC 17025-accredited calibration services ensure particle counter accuracy verification aligned with industry standards.

Techmaster US

Particle Counter Calibration Process at Techmaster

Our process follows ISO 21501-4 and includes:

  • Inspection – Detect contamination or sensor wear

  • Testing – Validate flow rate and particle sizing against standards

  • Adjustment – Fine-tune device output to ensure accurate performance

  • Certification – Issue NIST-traceable certificate with full data and uncertainty

➤ Ask about our particle counter maintenance services to keep your equipment in peak condition.

Trusted Standards That Support Cleanroom Validation

Techmaster follows internationally recognized frameworks for particle counter calibration:

  • ISO/IEC 17025 – Accredited through ANAB, ensuring global recognition

  • ANSI/NCSL Z540.1 – Compliance for U.S. defense and aerospace clients

  • NIST Traceability – Your calibration is backed by national standards

  • ILAC-G8 – Clear conformity statements for audit-ready documentation

These standards ensure your particle counting results meet the strictest regulatory requirements.

“Techmaster’s ISO 17025-calibrated reports helped us pass our FDA audit without findings.” – Quality Director, Medical Device Firm

In-House vs. Professional Particle Counter Calibration

Criteria In-House Calibration Techmaster Calibration
Accuracy & Traceability Basic tools, limited experience NIST-traceable, ISO/IEC 17025
Compliance Risky for GMP/ISO audits Meets ISO 21501-4 and FDA
Documentation May lack full data Certificates with uncertainties
Resources Needed Equipment, SOPs, trained staff Turnkey, zero burden
Downtime Risk Higher due to delays or errors On-site service available

 

Technicians in a semiconductor cleanroom
Semiconductor cleanroom with strict contamination control

How Often Should Particle Counters Be Calibrated?

  • Annually, based on most manufacturers’ recommendations

  • Every 6 months, for dusty or high-risk cleanrooms

  • Before audits, especially for GMP-regulated operations

Which Calibration Level Is Right for You?

We offer three service tiers for particle counter calibration services:

  • Commercial Calibration – NIST traceable, ideal for internal QA

  • Z540.1 Calibration – Includes test data and suitable for U.S. defense

  • ISO/IEC 17025 Calibration – Provides uncertainties and ILAC MRA recognition

➤ Need help selecting the right level? Our experts are here to advise.

Frequently Asked Questions (FAQ)

Q1: What’s the difference between calibration and verification?
A: Calibration adjusts device output and includes a traceable certificate; verification only confirms current accuracy.

Q2: Can I calibrate my particle counter on-site?
A: Yes, Techmaster provides ISO/IEC 17025-accredited on-site calibration services.

Q3: What’s included in the certificate?
A: Measurement results, uncertainty values, NIST traceability, and ISO 21501-4 conformity.

Q4: What are particle counter maintenance services?
A: Regular inspections, cleaning, and minor adjustments to prevent drift and ensure longevity.

Ready for Audit-Ready Accuracy? Contact Techmaster

With a legacy of over 30 years in metrology, Techmaster provides reliable particle counter calibration across industries. Our ISO-accredited services, fast turnaround, and cleanroom expertise make us a trusted calibration partner.

👉 Contact us today to get a free consultation and ensure your particle counters meet the highest standards for accuracy and compliance.