NABL Accredited · CC-2480 · Est. 2004 · Gujarat's Trusted Calibration Lab
NABL-accredited HEPA filter integrity testing for LAF cabinets, biosafety cabinets, and clean rooms. ISO 14644 traceable, accepted by WHO GMP, NABH, FDA, and all pharmaceutical audit bodies.
0.3 μm
Particle Size
99.97%
Efficiency
ISO 14644
Standard
ISO 14644
Clean Room Standard
NABL Accredited
CC-2480
— WHAT IS HEPA FILTER VALIDATION —
A HEPA filter rated at 99.97% efficiency is only as good as its installation. Even a pinhole-sized leak in the filter seal or housing can allow unfiltered air — carrying bacteria, viruses, and particles — to contaminate a pharmaceutical clean room, hospital OT, or biosafety cabinet. The filter specification alone is not proof of performance.
HEPA filter validation involves a DOP/PAO aerosol challenge test where the filter is challenged with a standardized aerosol upstream, and a photometer scans the downstream face for any penetration. Coupled with airflow velocity measurements and particle counting, this provides documented evidence that your clean area meets ISO 14644 classification requirements — mandatory for WHO GMP, Schedule M, and FDA facility audits.
Challenge
DOP/PAO aerosol challenge applied upstream at standard concentration; downstream scanned for penetration.
Measure
Airflow velocity, particle counts, and filter efficiency documented at defined grid points.
Certify
NABL CC-2480 validation certificate issued — accepted by WHO GMP, NABH, FDA, and CDSCO.
— INSTRUMENTS COVERED —
LAF cabinets, biosafety cabinets, clean room filters, and integrity testers — all validated per ISO 14644.
Photometric and particle counter-based DOP/PAO challenge tests verifying HEPA filter integrity and pinhole leaks.
LAF cabinet validation including airflow velocity, HEPA filter integrity, particle counts, and cleanliness classification.
Class II BSC performance testing — HEPA filter integrity, inflow/downflow velocity, and containment verification.
Clean room area classification and HEPA filter leak testing per ISO 14644 for pharmaceutical and hospital environments.
— OUR PROCESS —
Equipment received and tagged. Pre-test visual inspection — filter condition, cabinet seal integrity, blower function, and UV light operation documented.
Average downflow and inflow velocities measured using calibrated anemometers at defined grid points per NSF 49 and EN 12469.
Filter integrity verified using DOP or PAO aerosol challenge at 100% concentration upstream — downstream scan for penetration points using photometer.
Particle counting performed at 0.3 μm and 0.5 μm particle sizes to classify cleanliness level per ISO 14644-1.
Post-test functional verification including alarms, lighting, and blower performance. All results compiled with uncertainty statements.
NABL CC-2480 certificate issued covering filter efficiency, airflow, and particle counts — accepted by WHO GMP, NABH, and FDA inspectors.
— STANDARDS & COMPLIANCE —
Every HEPA filter validation is performed under ISO 14644 and NSF 49, with full traceability to NPL national standards. Our certificates satisfy WHO GMP, Schedule M, FDA, and NABH audit requirements.
ISO/IEC 17025
NABL Accreditation Standard
ISO 14644
Clean Room Classification
NSF 49
Biosafety Cabinet Standard
ISO 13485
Medical Device QMS
NABH
Hospital Accreditation
WHO GMP
GMP Compliance
FDA 21 CFR
US FDA Compliance
Schedule M
Indian GMP Standard
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.
