WHO GMP · EU GMP Annex 1 (2022) · NABL CC-2480 · Est. 2004
Clean Room
Validation Services
Gujarat's most trusted GMP clean room validation — ISO 14644, EU GMP Annex 1 (2022), WHO TRS 970, FDA 21 CFR, and Schedule M India. Full DQ / IQ / OQ / PQ documentation. Onsite across all Gujarat pharma clusters.
GMP Validated
WHO · EU · FDA
ISO 14644
Clean Room Std
— WHAT IS CLEAN ROOM VALIDATION —
Clean Room Validation —
What It Means & Why It Is Mandatory
Clean room validation is the documented process of proving that a controlled environment — ISO Class 5, EU GMP Grade A/B, or any GMP grade — consistently delivers the specified particle count, air change rate, pressure differential, airflow velocity, temperature, and humidity under all operating conditions.
Mandatory under EU GMP Annex 1 (2022) and Schedule M India
Both the revised EU GMP Annex 1 (2022) and India's revised Schedule M (2023) require full DQ/IQ/OQ/PQ qualification before a clean room can be used for manufacturing. Unvalidated rooms = product rejection at regulatory inspection.
NABL-traceable instruments give your report legal standing
Under FDA 21 CFR Part 211.68 and WHO GMP, all measuring instruments used in validation must have calibration certificates with metrological traceability. Prism uses only NABL CC-2480 calibrated instruments.
One contamination event costs far more than one validation
A sterility failure in a Grade A filling room requires full investigation, batch rejection, and regulatory notification. A validated clean room with documented evidence prevents this — and proves due diligence in audits.
GMP Clean Room Grades — Quick Reference
EU GMP Annex 1 (2022) / WHO TRS 970
What We Test — Room by Room
ISO 14644 / EU GMPParticle Count
ISO 14644-1, 0.5 µm & 5.0 µm channels
HEPA Integrity
EN 1822, PAO/DOP photometric scan
Air Change Rate
ISO 14644-3, anemometer traverse
DP Cascade
EU GMP Annex 1, 5–20 Pa verification
T&H Mapping
ICH Q1A, NABL data loggers
Microbiology
EU GMP Annex 1 (2022) Table 1 limits
— ACCEPTANCE CRITERIA —
Clean Room Test Parameters & GMP Acceptance Limits
Every parameter Prism tests — with the exact acceptance limits per EU GMP Annex 1 (2022), WHO TRS 970, and ISO 14644. Used directly in your OQ/PQ protocol.
| Parameter | Grade A / ISO 5 | Grade B / ISO 5* | Grade C / ISO 7 | Grade D / ISO 8 |
|---|---|---|---|---|
| ≥0.5 µm particles/m³ (at-rest) | ≤3,520 | ≤3,520 | ≤352,000 | ≤3,520,000 |
| ≥0.5 µm particles/m³ (in-operation) | ≤3,520 | ≤352,000 | ≤3,520,000 | Not defined |
| ≥5.0 µm particles/m³ (in-operation) | ≤20 | ≤2,900 | ≤29,000 | Not defined |
| Air Change Rate (ACH) | Unidirectional ≥0.36 m/s | ≥20 ACH | ≥20 ACH | ≥10–15 ACH |
| Differential Pressure (adjacent rooms) | ≥10–15 Pa | ≥10–15 Pa | ≥10–15 Pa | ≥5–10 Pa |
| HEPA Filter Efficiency | H14 ≥99.995% | H13 ≥99.97% | H13 ≥99.97% | H13 optional |
| Temperature | 20–22°C ±2°C | 20–22°C ±2°C | 20–25°C ±2°C | As per process |
| Relative Humidity | 45–55% ±5% | 45–55% ±5% | 45–65% ±5% | As per process |
| Settle plates (CFU/4h) — Microbiology | < 1 | 5 | 50 | 100 |
| Active air (CFU/m³) — Microbiology | < 1 | 10 | 100 | 200 |
Source: EU GMP Annex 1 (2022) Table 1 & Table 2 · WHO TRS 970 · ISO 14644-1:2015. * Grade B at-rest = ISO Class 5; in-operation = ISO Class 7.
— WHAT YOU GET —
Every Clean Room Validation Includes
Complete end-to-end GMP validation — from onsite testing to regulatory-ready documentation.
Onsite at Your Facility
Validation engineers arrive at your pharma plant with portable particle counters, anemometers, and data loggers. No room shutdown required.
Full ISO 14644 Testing
Particle count, HEPA integrity PAO/DOP, ACH measurement, airflow velocity mapping, differential pressure cascade — all in one visit.
DQ / IQ / OQ / PQ Protocols
Complete GMP lifecycle documentation — Design, Installation, Operational, and Performance Qualification per EU GMP Annex 1 (2022) and WHO TRS 970.
GMP Validation Report
Regulatory-ready validation report with all test data, acceptance criteria, measurement uncertainty, deviations, and CAPA — within 5–7 days.
Fast Report Turnaround
Preliminary findings within 48 hours of testing. Final validated report with all annexures delivered within 5–7 working days of site work.
NABL-Calibrated Instruments
All instruments (particle counters, anemometers, data loggers, manometers) are NABL CC-2480 calibrated — mandatory traceability for GMP.
Microbiological Monitoring
Settle plates, contact plates, and active air sampling as per EU GMP Annex 1 (2022) Table 1 alert and action limits — results included in PQ.
Annual Requalification Program
Scheduled 6-monthly or annual requalification with reminder service — keeps your clean rooms perpetually compliant for audit readiness.
Onsite Across Gujarat · WHO GMP · EU GMP Annex 1
Ready to Validate Your Clean Room?
Onsite service · 5–7 day report delivery · FDA, WHO and EU GMP accepted documentation
— OUR PROCESS —
Clean Room Validation Process — Step by Step
Every validation follows the GMP qualification lifecycle per EU GMP Annex 1 (2022) and ISPE Baseline Guide for Sterile Manufacturing.
Design Qualification (DQ)
Review room drawings, HVAC design, HEPA filter specs, and GMP classification requirements. Validation Master Plan drafted with scope, acceptance criteria, and test schedule.
Installation Qualification (IQ)
Verification that clean room, HVAC, HEPA filters, pressure gauges, and monitoring systems are installed per approved design drawings and manufacturer specifications.
Operational Qualification (OQ)
At-rest testing: particle counts, HEPA PAO/DOP integrity scan, ACH measurement, airflow velocity, differential pressure cascade, and T&H mapping with all systems running.
Performance Qualification (PQ)
In-operation testing with full production crew simulating worst-case conditions. Microbiological monitoring — settle plates, contact plates, active air sampling — per EU GMP Annex 1 (2022).
Deviation & CAPA
OOS results documented as deviations with root cause analysis and corrective actions (CAPA). Retesting performed before final qualification sign-off. Full audit trail maintained.
GMP Validation Report
Comprehensive report with all test data, acceptance criteria, deviation summary, and conclusion — ready for FDA, WHO GMP, EU GMP, GPCB, or NABH audits within 5–7 days.
Industry Applications
Industries That Require Clean Room Validation
Any regulated manufacturing or healthcare environment where air quality directly impacts product safety or patient health requires validated clean rooms.
Pharmaceutical & API
EU GMP Annex 1 (2022) and WHO TRS 970-compliant validation for sterile, non-sterile, API, and solid dose manufacturing clean rooms.
Know MoreBiotech & Biopharma
Cell culture, fermentation, and fill-finish clean room qualification per FDA 21 CFR Part 210/211 and ICH Q7 GMP guidelines.
Know MoreMedical Device Manufacturing
ISO 14644-1 classification and EN ISO 13485-compliant clean room qualification for medical device production under MDR/IVDR.
Know MoreHospital Operation Theatres
OT clean room qualification per NABH and MoHFW guidelines — particle count, positive pressure, and ACH verification.
Know MoreElectronics & Semiconductor
ISO Class 3–6 clean room qualification for semiconductor fab, PCB, and precision electronics manufacturing.
Know MoreNutraceutical & Food
Controlled environment qualification for nutraceutical, food supplement, and clinical nutrition manufacturing per FSSAI and HACCP.
Know MoreResearch & Reference Labs
ISO 14644-1 classification for university research labs, reference testing facilities, and NABL-accredited analytical labs.
Know MoreDiagnostic & Clinical Labs
Clean room classification for molecular diagnostics, PCR labs, and blood bank environments per NABH and ISO 15189 standards.
Know MoreWhy Choose Prism
Two Decades of GMP Validation.
Zero Audit Observations.
Since 2004, every clean room validation report issued by Prism has been accepted by FDA, WHO GMP, EU GMP, GPCB, and NABH auditors — no observations raised, no rework, no compliance gaps.
— STANDARDS & COMPLIANCE —
Validation Backed by All Major Regulatory Standards
Every clean room validation at Prism follows documented protocols aligned with international pharmaceutical and industrial standards — certificates accepted by FDA, WHO, EU, GPCB, and NABH inspectors.
ISO 14644-1:2015
Clean room classification by particle count
ISO 14644-3:2019
Performance test methods for clean rooms
EU GMP Annex 1 (2022)
Sterile medicinal products manufacturing
WHO TRS 970
WHO supplementary GMP guidelines
FDA 21 CFR 211.42
US FDA design and construction
Schedule M India (2023)
Indian GMP clean room requirements
EN 1822 / ISO 29463
HEPA filter classification and testing
ISO/IEC 17025:2017
NABL accreditation — CC-2480
NABL CC-2480 + 20 Years GMP Track Record
Prism holds NABL accreditation CC-2480 under ISO/IEC 17025:2017, recognized under the ILAC MRA agreement. All measuring instruments used in clean room validation are NABL calibrated — giving every validation report full regulatory traceability for FDA, WHO, EU GMP, GPCB, and NABH audits without exception.
850+
Clean Rooms Validated
0
Audit Observations Raised
— NON-GMP QUALIFICATION —
Routine ISO 14644 Classification for Non-GMP Facilities
Not every clean room requires full pharmaceutical GMP DQ/IQ/OQ/PQ. For hospitals, medical device workshops, semiconductor labs, food facilities, and R&D environments — Prism offers ISO 14644-1 classification and routine qualification at cost-effective pricing with the same NABL-calibrated instruments and test methods.
NABL-Traceable Instruments
All particle counters, anemometers, and data loggers are NABL CC-2480 calibrated regardless of whether the report is GMP or non-GMP.
Faster Completion
ISO 14644-1 classification reports completed within 3–5 working days. GMP DQ/IQ/OQ/PQ packages take 10–15 days.
Flexible Test Scope
Choose only the tests you need — particle count only, or particle + HEPA + ACH — priced per parameter for smaller facilities.
Onsite — No Disruption
All testing done at your facility with portable instruments. No room shutdown; tests scheduled around your operating shifts.
Onsite Coverage
Serving All
of Gujarat
Validation engineers based in Ahmedabad (GIDC Vatva) cover the full Gujarat pharma corridor — Dahej, Bharuch, Ankleshwar to Ahmedabad, Vadodara, and Surat.
— VALIDATION SERVICES —
Validation Services We Offer
8 GMP validation services — ISO 14644 to 21 CFR Part 11 — 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
Need a custom validation scope? We handle any combination of tests for any GMP grade.
— Our Clients —
Trusted By Gujarat's Leading Pharma Companies
— CLIENT VOICES —
What Our Clean Room Validation Clients Say
Prism validated all our clean rooms under EU GMP Annex 1 (2022) and WHO TRS 970. Every particle count, HEPA integrity test, and pressure differential report was accepted in our US FDA and WHO GMP audits — zero observations in 5 consecutive inspections.
Clean room DQ/IQ/OQ/PQ by Prism for our new API block — particle counting, HEPA PAO testing, ACH measurement, and T&H mapping done onsite. Report issued within 5 days, accepted directly in EU GMP inspection.
Annual clean room requalification across 12 Grade B/C rooms handled by Prism. Consistent, GMP-standard reports with proper measurement uncertainty. NABL-traceable instruments, professional team, zero rework requests.
Prism validated all our clean rooms under EU GMP Annex 1 (2022) and WHO TRS 970. Every particle count, HEPA integrity test, and pressure differential report was accepted in our US FDA and WHO GMP audits — zero observations in 5 consecutive inspections.
Clean room DQ/IQ/OQ/PQ by Prism for our new API block — particle counting, HEPA PAO testing, ACH measurement, and T&H mapping done onsite. Report issued within 5 days, accepted directly in EU GMP inspection.
Annual clean room requalification across 12 Grade B/C rooms handled by Prism. Consistent, GMP-standard reports with proper measurement uncertainty. NABL-traceable instruments, professional team, zero rework requests.
Prism validated all our clean rooms under EU GMP Annex 1 (2022) and WHO TRS 970. Every particle count, HEPA integrity test, and pressure differential report was accepted in our US FDA and WHO GMP audits — zero observations in 5 consecutive inspections.
Clean room DQ/IQ/OQ/PQ by Prism for our new API block — particle counting, HEPA PAO testing, ACH measurement, and T&H mapping done onsite. Report issued within 5 days, accepted directly in EU GMP inspection.
Annual clean room requalification across 12 Grade B/C rooms handled by Prism. Consistent, GMP-standard reports with proper measurement uncertainty. NABL-traceable instruments, professional team, zero rework requests.
Get In Touch
Request a Free Quote
Tell us your clean room grade, area, number of rooms, and regulatory requirement (FDA / WHO / EU GMP). Our team responds within 2 business hours with scope and cost estimate.
— FAQ —
Clean Room Validation — Frequently Asked Questions
Everything about ISO 14644, EU GMP Annex 1 (2022), and GMP clean room validation in Gujarat.
Need Clean Room Validation in Gujarat?
Call or WhatsApp — we reply within the hour. Onsite across all Gujarat, GMP validation 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
Clean room validation and qualification services are performed per ISO 14644, EU GMP Annex 1 (2022), WHO TRS 970, and applicable regulatory guidelines. Measuring instruments used are NABL calibrated under Certificate CC-2480 (ISO/IEC 17025:2017). Validation reports are prepared per client-approved protocols; Prism does not assume regulatory approval responsibility on behalf of the client.