NABL Accredited · CC-2480 · Est. 2004 · Gujarat's Trusted Calibration Lab
NABL-accredited IQ/OQ/PQ validation for pre-vacuum, gravity, flash, and tabletop sterilizers. ISO 17665 traceable, accepted by NABH, FDA, and WHO GMP auditors.
100–140°C
Range
±0.5°C
Accuracy
ISO 17665
Standard
ISO 17665
Sterilization Standard
NABL Accredited
CC-2480
— WHAT IS STERILIZER VALIDATION —
Imagine surgical instruments coming out of an autoclave that completed its cycle, displayed "sterile," yet a cold spot in the chamber meant a fraction of the load never reached sterilizing temperature — an invisible failure with patient-safety consequences.
Sterilizer validation is a documented IQ/OQ/PQ process that maps chamber temperature at multiple points, calculates the F0 value, and runs a biological indicator challenge to prove the sterilizer consistently achieves the required sterility assurance level. A NABL certificate confirms ISO 17665 compliance — accepted by NABH, WHO GMP, and FDA auditors.
Check
Chamber temperature mapped at multiple points using NABL-traceable RTD probes across a full load.
Correct
F0 value calculated and compared against baseline; deviations flagged for corrective action.
Certify
NABL CC-2480 certificate plus IQ/OQ/PQ validation report issued with full traceability.
— STERILIZER TYPES COVERED —
Pre-vacuum, gravity displacement, flash, and tabletop sterilizers across all major brands.
High-vacuum B-class autoclaves for porous loads validated per EN 13060 including Bowie-Dick test.
N-class and S-class gravity autoclaves validated for temperature uniformity and cycle performance.
Immediate-use steam sterilizer validation — temperature accuracy, hold time, and cycle completion.
Small dental and laboratory tabletop autoclaves validated with steam penetration and cycle verification.
— VALIDATION APPROACH —
Sterilizer installation verified — utilities, chamber dimensions, safety interlocks, documentation confirmed against design specifications.
Empty chamber temperature distribution mapping. Bowie-Dick test. Safety valve and door interlock test. Cycle timer calibration.
Temperature mapping with full load. F0 value calculation. Biological indicator challenge run. Three consecutive successful cycles documented.
Temperature and pressure readings captured against NABL-traceable RTD probes at multiple chamber points. Deviations recorded.
Annual temperature distribution mapping on loaded chamber. F0 verification compared with OQ baseline.
NABL CC-2480 certificate plus IQ/OQ/PQ validation report with all data, F0 calculations, uncertainty (k=2), traceability issued.
— STANDARDS & COMPLIANCE —
Every sterilizer validation is performed under ISO 17665 and EN 13060, with full traceability to NPL national standards. Our certificates satisfy all hospital and pharmaceutical regulatory audit requirements.
ISO/IEC 17025
NABL Accreditation Standard
ISO 17665
Moist Heat Sterilization
EN 13060
Steam Sterilizer Standard
ISO 13485
Medical Device QMS
NABH
Hospital Accreditation
WHO GMP
GMP Compliance
HTM 01-01
UK Decontamination Guidance
ISO 9001:2015
Quality Management
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 validation, 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.
