ISO 14644 · EU GMP Annex 1 (2022) · ASHRAE · NABL CC-2480
AHU Validation
Services
Gujarat's trusted AHU and HVAC validation partner — ISO 14644, EU GMP Annex 1 (2022), WHO TRS 970, ASHRAE 52.2, CIBSE TM31 compliant. Airflow velocity, ACH, HEPA PAO integrity test, differential pressure cascade. Full DQ/IQ/OQ/PQ. Onsite across Gujarat.
GMP Validated
WHO · EU · FDA
ISO 14644
EU GMP Annex 1
— WHAT IS AHU VALIDATION —
AHU / HVAC Validation —
Mandatory for GMP Clean Rooms
AHU validation provides documented evidence that your Air Handling Unit and HVAC system consistently supplies air that meets the required clean room class specifications — airflow velocity, ACH, HEPA filter integrity, differential pressure cascade, temperature, and humidity — as defined by EU GMP Annex 1 (2022) and ISO 14644.
EU GMP Annex 1 (2022) mandates HVAC qualification for all Grade A/B/C/D areas
The revised EU GMP Annex 1 (2022) requires that all HVAC systems supplying classified clean room areas be qualified with documented DQ/IQ/OQ/PQ before use and requalified periodically. A HEPA filter failure or ACH shortfall detected in an audit is a critical GMP deficiency.
PAO integrity test is the only way to detect HEPA filter leaks
Visual inspection cannot detect HEPA filter media damage, gasket leaks, or frame bypass leaks. The PAO aerosol challenge test per EN ISO 14644-3 is the only validated method — required annually for all pharmaceutical Grade A/B areas.
A pressure reversal in sterile manufacturing = potential contamination event
If differential pressure cascade fails — lower pressure in a Grade B area than adjacent Grade C — contamination can migrate into the sterile manufacturing area. HVAC validation with pressure cascade verification prevents this critical contamination risk.
AHU Validation — Acceptance Criteria
ISO 14644 / EU GMP Annex 1 (2022)
Grade A (ISO 5) ACH
Unidirectional 0.36–0.54 m/s at filter face
Grade B (at rest, ISO 5)
Particle count ≤3,520 / m³ (≥0.5 µm)
Grade C (ISO 7)
Particle count ≤352,000 / m³ (≥0.5 µm)
Grade D (ISO 8)
Particle count ≤3,520,000 / m³ (≥0.5 µm)
Differential pressure
Min 10–15 Pa between adjacent grades
HEPA PAO integrity
≤0.01% penetration at any scan point
— WHAT YOU GET —
Every AHU Validation Includes
Complete GMP AHU validation package — from DQ review to regulatory-ready qualification report.
Onsite at Your Facility
Engineers arrive with calibrated velocity meters, PAO generator/photometer, particle counter, and differential pressure instruments. No AHU shutdown required.
Airflow Velocity & ACH
Grid method airflow velocity profile measurement per ISO 14644-3. Volume flow rate and ACH calculation at every supply diffuser and terminal HEPA filter.
HEPA PAO Integrity Test
PAO aerosol challenge test per EN ISO 14644-3 Annex B.6 — full scan of every installed HEPA terminal filter for leaks in media, frame, and gasket. Results included in OQ report.
GMP Validation Report
Full DQ/IQ/OQ/PQ report with airflow data, HEPA test results, particle counts, differential pressure records, and conclusion — in EU GMP Annex 1 format within 7 days.
Differential Pressure Cascade
Verification of differential pressure cascade between all classified areas using calibrated Magnehelic and digital manometers. Results vs EU GMP Annex 1 acceptance criteria.
Particle Count & Microbial
ISO 14644-1 particle count at rest and in operation. Microbial monitoring (settle plates, contact plates, active air sampling) per EU GMP Annex 1 Grade A/B/C/D limits.
NABL-Calibrated Instruments
All velocity meters, PAO generators, photometers, particle counters, and pressure gauges are NABL CC-2480 calibrated — mandatory for GMP qualification traceability.
Annual Requalification Program
Scheduled annual AHU requalification with HEPA integrity test, velocity mapping, and particle count — keeps your clean rooms perpetually EU GMP compliant.
Onsite Across Gujarat · ISO 14644 · EU GMP Annex 1
Ready to Validate Your AHU / HVAC?
Onsite service · 7-day report delivery · FDA, WHO, EU GMP accepted
— OUR PROCESS —
AHU Validation Process — Step by Step
Design Qualification (DQ)
Review AHU design specifications: airflow volumes (CMH), filtration stages (G4/F8/H14), fan specifications, duct layout, pressure cascade design, and control system. DQ verifies the design meets clean room class requirements per ISO 14644 and EU GMP Annex 1.
Installation Qualification (IQ)
Verification that the AHU, ducting, dampers, HEPA terminal filters, differential pressure gauges, airflow monitors, and BMS connections are installed per approved drawings, specifications, and manufacturer requirements.
OQ — Airflow & HEPA Testing
Airflow velocity profile measurement (grid method), volume flow rate and ACH calculation, HEPA filter PAO/DOP integrity test (per EN ISO 14644-3), differential pressure cascade verification, and temperature/humidity uniformity.
PQ — Clean Room Performance
Particle count per ISO 14644-1 (at rest and in operation), microbial monitoring (settle plates, active air sampling), recovery time study, cross-contamination risk assessment, and smoke pattern/airflow visualisation study.
Deviation & CAPA Management
Any failed HEPA integrity test, airflow velocity outside specification, ACH shortfall, or pressure reversal documented as deviation with root cause and CAPA. Retesting after CAPA before final sign-off.
Validation Report Issued
Complete DQ/IQ/OQ/PQ validation report with all airflow data, HEPA test results, particle counts, microbial data, differential pressure records, and conclusion — GMP-ready within 7 days.
Industry Applications
Industries That Require AHU Validation
Sterile Pharmaceutical Mfg
AHU validation for Grade A/B/C/D clean rooms per EU GMP Annex 1 (2022) and ISO 14644 — PAO HEPA test, ACH, velocity, and pressure cascade qualification.
Know MoreAPI Manufacturing
HVAC/AHU qualification for contained API synthesis and handling areas per EU GMP and ISPE Baseline Guide 2 for Bulk Pharmaceutical Chemicals.
Know MoreMedical Device Manufacturing
AHU/HVAC qualification for ISO Class 5–8 clean rooms used in medical device manufacturing per ISO 13485 and EU MDR 2017/745.
Know MoreBiotechnology & Biologics
Biosafety cabinet and clean room HVAC validation for containment and sterility in biologics manufacturing per WHO GMP and EU GMP Annex 2.
Know MoreHospital Operating Theatres
AHU qualification for hospital operation theatres and ICUs per NABH, ASHRAE 170, and MoHFW infection control standards.
Know MoreFood & Beverage Processing
Positive pressure HVAC qualification for food processing clean rooms per FSSAI, FSSC 22000, and BRC Global Standards.
Know MoreElectronics & Semiconductor
AHU/HVAC validation for electrostatic-sensitive and contamination-controlled manufacturing environments per ISO 14644 Class 3–7.
Know MoreNutraceuticals & Cosmetics
Clean room HVAC qualification for nutraceutical and cosmetics manufacturers per GMP and ASEAN Cosmetic GMP guidelines.
Know MoreWhy Choose Prism
Two Decades of GMP Validation.
Zero Audit Observations.
Since 2004, every AHU validation report issued by Prism has been accepted by USFDA, WHO GMP, EU GMP, GPCB, and NABH auditors without a single observation or rework.
— STANDARDS & COMPLIANCE —
Standards We Follow for AHU Validation
ISO 14644-1:2015
Classification of air cleanliness
ISO 14644-3:2019
Test methods incl. HEPA integrity
EU GMP Annex 1 (2022)
Sterile medicinal products
WHO TRS 970
WHO GMP supplementary guidelines
ASHRAE 52.2
HVAC filter testing — MERV ratings
CIBSE TM31
Clean room testing and monitoring
ISPE Baseline HVAC
ISPE Good Practice Guide HVAC
ISO/IEC 17025:2017
NABL accreditation CC-2480
NABL CC-2480 + EU GMP Annex 1 (2022)
All instruments are NABL CC-2480 calibrated. Every AHU validation report is accepted in USFDA, WHO GMP, EU GMP, GPCB, and NABH audits — updated to the latest EU GMP Annex 1 (2022) methodology.
800+
AHUs Validated
0
Audit Observations
— NON-GMP AHU TESTING —
AHU Testing for Non-Pharma Applications
Hospitals, food processors, electronics manufacturers, and offices also require clean air — but without full pharma GMP qualification. Prism offers HVAC testing and HEPA integrity testing for non-GMP environments using the same NABL-calibrated instruments.
NABL-Traceable Instruments
All instruments NABL CC-2480 calibrated for GMP and non-GMP AHU testing.
Fast Completion
AHU airflow survey completed in 1–2 days; full DQ/IQ/OQ/PQ in 5–7 days.
Flexible Test Scope
Choose specific tests — velocity only, HEPA only, or full qualification.
Onsite — No Shutdown
All testing at your facility; minimal disruption to operations.
Onsite Coverage
Serving All
of Gujarat
Validation engineers based in Ahmedabad cover the full Gujarat pharma corridor onsite.
— VALIDATION SERVICES —
Validation Services We Offer
8 GMP validation services — all under one NABL-accredited roof. View all services →
Clean Room Validation
4 test parameters
- ISO 14644-1 Particle Count
- HEPA Filter PAO/DOP Test
- ACH & Airflow Velocity
- Differential Pressure Cascade
Autoclave / Sterilizer
4 test parameters
- Temperature Distribution Study
- Heat Penetration Study
- IQ / OQ / PQ Documentation
- Bowie-Dick & Leak Test
Stability Chamber
4 test parameters
- T&H Mapping (ICH Q1A)
- Uniformity Verification
- IQ / OQ / PQ Protocols
- Data Logger Calibration
DQ / IQ / OQ / PQ
4 test parameters
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
AHU Validation
4 test parameters
- Airflow & Velocity Balancing
- HEPA Integrity Testing
- Pressure & ACH Verification
- Filter Efficiency Testing
PLC / Software Validation
4 test parameters
- 21 CFR Part 11 Compliance
- GAMP 5 Validation
- IQ / OQ / PQ for Software
- Audit Trail Verification
Thermography / Oven
4 test parameters
- Hot Air Oven Temperature Mapping
- Thermal Distribution Study
- Infrared Thermography
- IQ / OQ / PQ Documentation
Performance Qualification
4 test parameters
- Worst-Case PQ Testing
- Process Performance Study
- Statistical Acceptance Criteria
- GMP-Ready PQ Report
— Our Clients —
Trusted By Gujarat's Leading Pharma Companies
— CLIENT VOICES —
What Our AHU Validation Clients Say
Prism validated our 8 AHU units in the new sterile manufacturing block — airflow velocity, ACH, HEPA integrity (PAO test), differential pressure cascade, and temperature uniformity. All per EU GMP Annex 1 (2022). Completed in 5 days, zero observations in USFDA audit.
AHU validation by Prism for our Grade A/B injectable filling line — velocity profiles, HEPA DOP integrity, unidirectional airflow (UDAF) qualification, and recovery time study. Complete DQ/IQ/OQ/PQ package delivered in 7 days, accepted by EU GMP inspector.
Annual AHU requalification by Prism — all 14 AHUs mapped for velocity, ACH, HEPA integrity, and pressure cascade. Report delivered in 5 days. Prism has been our AHU validation partner for 8 consecutive years.
Prism validated our 8 AHU units in the new sterile manufacturing block — airflow velocity, ACH, HEPA integrity (PAO test), differential pressure cascade, and temperature uniformity. All per EU GMP Annex 1 (2022). Completed in 5 days, zero observations in USFDA audit.
AHU validation by Prism for our Grade A/B injectable filling line — velocity profiles, HEPA DOP integrity, unidirectional airflow (UDAF) qualification, and recovery time study. Complete DQ/IQ/OQ/PQ package delivered in 7 days, accepted by EU GMP inspector.
Annual AHU requalification by Prism — all 14 AHUs mapped for velocity, ACH, HEPA integrity, and pressure cascade. Report delivered in 5 days. Prism has been our AHU validation partner for 8 consecutive years.
Prism validated our 8 AHU units in the new sterile manufacturing block — airflow velocity, ACH, HEPA integrity (PAO test), differential pressure cascade, and temperature uniformity. All per EU GMP Annex 1 (2022). Completed in 5 days, zero observations in USFDA audit.
AHU validation by Prism for our Grade A/B injectable filling line — velocity profiles, HEPA DOP integrity, unidirectional airflow (UDAF) qualification, and recovery time study. Complete DQ/IQ/OQ/PQ package delivered in 7 days, accepted by EU GMP inspector.
Annual AHU requalification by Prism — all 14 AHUs mapped for velocity, ACH, HEPA integrity, and pressure cascade. Report delivered in 5 days. Prism has been our AHU validation partner for 8 consecutive years.
Get In Touch
Request a Free Quote
Tell us the number of AHUs, clean room grades, and regulatory requirement. Our team responds within 2 business hours.
— FAQ —
AHU Validation — Frequently Asked Questions
Need AHU Validation in Gujarat?
Call or WhatsApp — we reply within the hour. Onsite across Gujarat, GMP report guaranteed.
Prism Calibration Centre · F 101, Rudraksh Complex 2, Phase 3, GIDC Vatva, Ahmedabad, Gujarat 382445
— FROM OUR BLOG —
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Read MoreValidation Services Disclaimer
AHU validation services are performed per ISO 14644, EU GMP Annex 1 (2022), WHO TRS 970, ASHRAE 52.2, and applicable regulatory guidelines. All instruments are NABL calibrated under Certificate CC-2480 (ISO/IEC 17025:2017).