NABL Accredited · CC-2480 · Est. 2004 · Gujarat's Trusted Calibration Lab
NABL-accredited calibration and validation for all autoclave and sterilizer types — Steam, Dry Heat, EO, and Temperature Mapping. EN 13060 / ISO 17665 traceable, accepted by WHO GMP, NABH, and FDA.
100–180°C
Range
±0.5°C
Accuracy
EN 13060
Standard
EN 13060
Autoclave Standard
NABL Accredited
CC-2480
— WHAT IS AUTOCLAVE VALIDATION —
Sterilization is one of the most critical processes in healthcare and pharmaceutical manufacturing. An autoclave running just 3°C below its set point can allow pathogens to survive — with no visible sign of failure. The instruments look sterilized, but they are not. This is why calibration and thermal validation are non-negotiable.
Autoclave validation involves verifying that the sterilizer achieves and maintains the required temperature, pressure, and time parameters across the full chamber volume. Temperature mapping confirms uniformity and eliminates cold spots. The result is documented evidence — a NABL certificate accepted by WHO GMP, Schedule M, NABH, and FDA — that your sterilization process consistently achieves the required sterility assurance level.
Map
Multi-point thermal mapping across the chamber volume detects cold spots and confirms uniformity.
Verify
Temperature, pressure, and time parameters verified against calibrated references at set point.
Certify
NABL CC-2480 validation certificate issued — accepted by WHO GMP, NABH, FDA, and Schedule M auditors.
— INSTRUMENTS COVERED —
Steam autoclaves, dry heat ovens, EO sterilizers, and thermal mapping — all validated per EN 13060 and ISO 17665.
Gravity and pre-vacuum steam autoclaves calibrated for temperature, pressure, and cycle time accuracy.
Hot air oven sterilizers validated for temperature uniformity and stability across the full sterilization zone.
Ethylene oxide sterilizer validation covering gas concentration, temperature, and humidity parameters.
Full thermal mapping of autoclave chamber using multi-point temperature loggers to verify uniformity.
— OUR PROCESS —
Autoclave received, tagged, and visually inspected — door seal, pressure gauge, safety valve, and temperature sensor connections documented as-found.
Calibrated temperature loggers or RTDs placed at defined mapping points. Pressure sensor connected to autoclave chamber port.
Full sterilization cycle run with all sensors active. Temperature, pressure, and time profiles recorded. Deviations from set point noted.
Minimum 12-point thermal mapping performed per EN 17665 to verify chamber uniformity within ±1°C of set temperature.
Post-adjustment cycle run confirms all calibration points within specification. Uncertainty calculated per ISO/IEC 17025.
NABL CC-2480 certificate issued with full cycle data, temperature mapping report, and EN 13060 / ISO 17665 traceability.
— STANDARDS & COMPLIANCE —
Every autoclave validation follows EN 13060, ISO 17665, and WHO GMP Technical Report requirements, with full traceability to NPL national temperature standards.
ISO/IEC 17025
NABL Accreditation Standard
EN 13060
Small Steam Sterilizers
ISO 17665
Moist Heat Sterilization
ISO 13485
Medical Device QMS
NABH
Hospital Accreditation
WHO GMP
GMP Compliance
Schedule M
Indian GMP Standard
FDA 21 CFR
US FDA Compliance
Prism holds NABL CC-2480 under ISO/IEC 17025:2017, recognized under the ILAC MRA agreement. Our biomedical calibration certificates are valid for WHO GMP, FDA, NABH, and all audit purposes.
— NON-NABL CALIBRATION —
For routine maintenance, bulk calibration, or facilities not needing NABL certification — Prism offers cost-effective non-NABL validation with the same trained engineers and traceable references.
All non-NABL jobs use the same NPL-traceable references — only the certificate type differs.
Non-NABL jobs completed faster — ideal for urgent maintenance or large bulk batches.
Priced lower than NABL — right choice for internal checks and non-audit use cases.
Available at our Ahmedabad lab and as onsite service across Gujarat — same team, same quality.
— AREAS WE SERVICE —
NABL-certified engineers travel to your facility across Gujarat — hospital, pharma, or laboratory onsite service.
Why Choose Prism
Since 2004, every NABL biomedical certificate issued by Prism has been accepted by WHO GMP, FDA, NABH, and ISO auditors — no rejections, no rework.
— FAQ —
Get In Touch
Tell us what you need validated and whether you need onsite or in-lab service. We respond within 2 business hours.
— FROM OUR BLOG —
NABL Accreditation Disclaimer
Calibration services are provided under NABL Certificate CC-2480 in strict accordance with our officially approved scope of accreditation (ISO/IEC 17025:2017). Parameters or onsite conditions falling outside our active NABL scope are processed with standard metrological traceability to NPL/BIPM national standards.
