Quick Answer
Prism Calibration Centre (NABL CC-2480) provides NABL-certified calibration for all cleanroom monitoring instruments in Ahmedabad: differential pressure gauges, temperature/humidity sensors, particle counters, anemometers, and air velocity meters — per ISO 14644, WHO GMP Annex 1, and EU GMP requirements.
Key Takeaways
- ISO 14644 cleanroom classification requires calibrated particle counters, anemometers, and DP gauges.
- WHO GMP Annex 1 (revised 2022) mandates continuous monitoring with calibrated sensors.
- Prism calibrates DP gauges (0–100 Pa range), anemometers (0.1–30 m/s), and humidity sensors (10–95% RH).
- Calibration of cleanroom instruments must be traceable to NABL/NPL for GMP compliance.
- Complete IQ/OQ/PQ documentation support for new cleanroom commissioning.
Cleanroom Instruments Calibrated by Prism
| Instrument | Parameter | Range |
|---|---|---|
| Differential Pressure Gauge/Transmitter | Room-to-room DP (Pa) | 0–200 Pa |
| Temperature Sensor / Transmitter | Room temperature | +15°C to +30°C |
| Humidity Sensor / Transmitter | Relative humidity | 30–70% RH |
| Anemometer (vane/hot wire) | Air supply velocity | 0.1–10 m/s |
| Particle Counter | Particle concentration (0.5–5 µm) | 0–10⁶ particles/m³ |
| Air Change Rate Meter | ACH (air changes/hour) | By anemometer + calculation |
| Magnehelic Gauge | Low differential pressure | 0–25 Pa to 0–2500 Pa |
ISO 14644 Cleanroom Classification Requirements
ISO 14644-1 classifies cleanrooms from ISO Class 1 (fewest particles) to ISO Class 9. Pharmaceutical cleanrooms are typically ISO Class 5 (EU Grade A), ISO Class 6 (Grade B), ISO Class 7 (Grade C), and ISO Class 8 (Grade D). Classification is based on airborne particle count per m³ at defined particle sizes (0.1, 0.2, 0.3, 0.5, 1, 5 µm). Particle counters used for classification must be calibrated by NABL-accredited labs.
Differential Pressure (DP) Monitoring — Critical for Cleanroom Integrity
Differential pressure between adjacent cleanroom zones is the primary indicator of cleanroom integrity. Positive pressure in clean zones prevents contamination ingress. Typical requirements: Grade A/B DP = +15 Pa above Grade C; Grade C = +10 Pa above Grade D; Grade D = +10 Pa above corridor. Differential pressure gauges and transmitters must be calibrated annually (or after any disturbance) by NABL labs to ensure accurate monitoring.
Frequently Asked Questions
Can Prism calibrate particle counters for cleanroom qualification?
Yes. Prism calibrates airborne particle counters by comparison with a calibrated reference particle counter and checks for counting efficiency at particle sizes 0.3 µm, 0.5 µm, and 1.0 µm.
How often should cleanroom instruments be calibrated?
ISO 14644-2 recommends calibration of monitoring instruments at least annually. For Grade A/B cleanrooms under WHO GMP Annex 1, continuous monitoring sensors should be calibrated every 6 months.
Is Prism's calibration accepted for EU GMP Annex 1 compliance?
Yes. Prism's NABL CC-2480 certificates carry ILAC MRA recognition, which satisfies EU GMP Annex 1 calibration requirements for pharmaceutical cleanrooms.
Can Prism calibrate cleanroom temperature and humidity sensors on-site?
Yes. On-site calibration of installed temperature and humidity sensors is available using portable NABL-calibrated reference instruments.
Does Prism provide IQ/OQ/PQ documentation for cleanroom commissioning?
Yes. Prism provides complete IQ/OQ documentation including NABL calibration certificates, instrument specifications, calibration procedures, and acceptance criteria for new cleanroom projects.
Written by
Er. Parthiv Kinariwala
Managing Director · Prism Calibration Centre · NABL CC-2480 · Ahmedabad
Er. Parthiv Kinariwala founded Prism Calibration Centre in 2004 and has over 20 years of hands-on experience in calibration engineering, NABL accreditation, and industrial compliance. His team performs 10,000+ calibrations annually from the Vatva GIDC laboratory, serving 5000+ industries across Gujarat.
Prism Calibration Centre — Vatva GIDC, Ahmedabad
Prism Calibration Centre
F-101, Rudraksh Complex 2, Phase 3, GIDC Vatva, Near Jasoda Nagar Cross Road, Ahmedabad — 382445, Gujarat, India
Phone: +91 98245 26444
Email: info@prismcalibration.com
NABL: CC-2480 · ISO/IEC 17025:2017
Hours: Mon–Sat, 9:00 AM – 7:00 PM