Quick Answer
Prism Calibration Centre (NABL CC-2480) provides comprehensive pharmaceutical instrument calibration in Ahmedabad: analytical balances, autoclaves, stability chambers, HPLC systems, pH meters, purified water systems, temperature data loggers, and cleanroom monitoring — all with FDA and WHO GMP-compliant documentation.
Key Takeaways
- FDA 21 CFR Part 211 and Schedule M mandate NABL calibration of all pharma measurement instruments.
- Prism calibrates 50+ types of pharmaceutical instruments used in API and formulation manufacturing.
- Complete calibration documentation packages for FDA inspection readiness.
- WHO pre-qualification and EU GMP calibration certificates available.
- Prism has 20+ years serving 200+ pharmaceutical companies in Ahmedabad, Gujarat.
Pharmaceutical Instruments We Calibrate
- Analytical Balances (0.0001 g to 200 g) — QC lab, dispensing
- Precision Balances (0.01 g to 2200 g) — formulation
- Autoclaves / Steam Sterilizers — temperature mapping + calibration
- Stability Chambers (ICH zones: 40°C/75% RH, 30°C/65% RH, 25°C/60% RH)
- Walk-in Cold Rooms and Refrigerators (2–8°C pharma fridges)
- pH Meters and pH Electrodes
- Conductivity Meters (for WFI/PW testing)
- TOC Analysers (water quality monitoring)
- HPLC Systems (column pressure, flow rate, temperature)
- Temperature Data Loggers (Testo, Ebro, Comark)
- Differential Pressure Gauges (cleanroom DP monitoring)
- Humidity Sensors (cleanroom and stability chamber)
- Syringe Pumps (delivery accuracy calibration)
- Dissolution Apparatus (speed and temperature)
FDA 21 CFR Part 211 Calibration Requirements
21 CFR Part 211 (cGMP for Finished Pharmaceuticals) Section 211.68 specifically requires: 'Automatic, mechanical, or electronic equipment or other types of equipment, including computers, or related systems that will perform a function satisfying the requirements of these regulations shall be calibrated, inspected, or checked according to a written program designed to assure proper performance.' Prism's NABL certificates include the documentation required to satisfy FDA inspection.
Stability Chamber Calibration & Mapping — ICH Q1A Compliance
Temperature Mapping
Place 9–27 calibrated temperature data loggers at defined grid points inside the chamber. Run 24–72 hour mapping study to confirm uniformity.
Humidity Mapping
Simultaneously map relative humidity at all grid points. Check uniformity ± 5% RH from setpoint.
Setpoint Calibration
Calibrate the chamber's built-in temperature and humidity sensors against NABL reference standards.
Alarm Verification
Test high and low temperature/humidity alarms at setpoints. Verify alarm response time.
Documentation
Issue mapping report, calibration certificates for all data loggers and chamber sensors, and ICH Q1A compliance statement.
Frequently Asked Questions
Is NABL calibration required for Schedule M compliance?
Yes. The Drugs and Cosmetics Act Schedule M (Good Manufacturing Practices) clause 11.1 requires calibration of instruments in API and formulation manufacturing. NABL accreditation provides the required traceability.
Can Prism calibrate autoclaves at my pharmaceutical plant?
Yes. Prism provides autoclave temperature mapping and calibration with calibrated multi-channel temperature loggers. We issue a complete validation report per ISO 17665 and FDA requirements.
Does Prism support WHO prequalification audits?
Yes. Prism's NABL CC-2480 certificates carry ILAC MRA recognition, which satisfies WHO prequalification calibration requirements. We have experience supporting pharma companies through WHO-PQ audits.
How often should stability chambers be calibrated?
Stability chambers should be calibrated annually, with temperature and humidity mapping at commissioning and after any significant repair or relocation. Daily performance monitoring (alarm check) is also required.
Can Prism calibrate the temperature and flow sensors in HPLC systems?
Yes. Prism calibrates HPLC column oven temperature sensors, mobile phase flow rate (using gravimetric method), UV/Vis detector wavelength, and pressure sensors in HPLC systems.
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