Quick Answer
Temperature data logger calibration at Prism (NABL CC-2480) uses a calibrated dry block calibrator or temperature bath as reference. The data logger is compared against a calibrated SPRT reference at 3–5 temperature points covering its application range, and a NABL certificate with ±0.1–0.5°C uncertainty is issued.
Key Takeaways
- Data logger calibration covers the full application range: typically -40°C to +100°C for cold chain.
- Pharma cold chain calibration points: +5°C, +25°C, +37°C (ICH), +40°C (accelerated testing).
- WHO GDP, USFDA, and Schedule M require NABL-calibrated data loggers for cold chain documentation.
- Calibration interval: annual minimum; 6-month for GDP-regulated cold rooms and vehicles.
- Prism calibrates Testo 175, Ebro EBI 20, HOBO U12, Comark, MSR, and all major brands.
Data Logger Brands Calibrated at Prism
- Testo (175, 176, 184, 480, 549i, 572)
- Ebro (EBI 20-T, EBI 300, EBI Pro)
- Onset HOBO (U12-013, MX2203)
- Comark (N2012, N2013 series)
- MSR (MSR165, MSR147)
- ELPRO (ECOLOG-T)
- Sensitech (TempTale 4)
- Dickson (KT8P2, DS517)
- Ryan (TWI)
- Rotronic (Log300)
- Hanna Instruments (HI500 series)
- Custom OEM data loggers for pharma
Cold Chain Data Logger Calibration for GDP Compliance
WHO Technical Report 1014 (Annex 9) — the updated GDP guideline — mandates calibration of all temperature monitoring devices used in pharmaceutical cold chain (2–8°C products: vaccines, biologics; -15 to -25°C products: some biologics, plasma). Calibration must be traceable and documented for GDP inspections. Prism provides NABL certificates for cold chain data loggers that satisfy WHO GDP, USFDA, and CDSCO requirements.
Stability Chamber Data Logger Calibration
ICH Q1A stability testing chambers (40°C/75% RH Zone IVa, 30°C/65% RH Zone III) use multiple temperature data loggers for temperature mapping. All loggers used in mapping must be NABL-calibrated with certificates stating accuracy at the mapping temperature setpoints. Prism calibrates batches of 5–50 data loggers simultaneously for stability chamber mapping projects in Gujarat pharma companies.
Frequently Asked Questions
How long does data logger calibration take at Prism?
Single data logger calibration takes 4–6 hours (including thermal stabilisation time). Batch calibration of 10–50 loggers can be completed within 24–48 hours.
Do data loggers need calibration if they are brand new?
Yes. New data loggers may have drifted from factory calibration during shipping and storage. Calibrating before first use establishes a verified baseline. FDA audit teams specifically check for pre-use calibration documentation.
Can Prism calibrate wireless IoT temperature sensors?
Yes. Prism calibrates IoT-connected temperature sensors (Bluetooth, WiFi, GPRS) by placing the sensor in a calibrated temperature bath and comparing readings with a NABL reference standard.
What calibration points are required for pharma cold chain at +2°C to +8°C?
Prism recommends calibration at: 0°C (below range), +5°C (midpoint), +8°C (upper limit), +15°C (excursion point). This covers the critical range for pharmaceutical cold chain monitoring.
Does Prism provide batch calibration certificates for large sets of data loggers?
Yes. Prism issues individual NABL certificates for each data logger. For batch orders, certificates are numbered sequentially and include the client's equipment ID/serial numbers for easy tracking.
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