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Validation Services

Comprehensive qualification protocols (DQ, IQ, OQ, PQ) for pharmaceutical cleanrooms, HVAC systems, autoclaves, and 24-hour cold chain thermal mapping.

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Validation Services Pak Metrology
cGMP & ISO 14644 COMPLIANT

Pharmaceutical & Cleanroom Qualification

COMPLIANCE & INTEGRITY

Validation Services

PAK METROLOGY SOLUTIONS provides end-to-end cleanroom validation, HVAC commissioning, and equipment qualification protocols designed to satisfy DRAP, US FDA, and WHO cGMP regulatory audits.

Our validation dossiers contain comprehensive air velocity profiles, particle counts, HEPA filter PAO integrity reports, and multi-channel thermal mapping charts with F0 lethality values.

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VALIDATION CAPABILITIES

Cleanroom, Thermal & Equipment Qualification

Cleanroom & HVAC System Validation

Complete airborne particle counting, airflow velocity testing, differential pressure mapping, and filter integrity testing compliant with ISO 14644 & US FED STD 209E.

  • Airborne Particle Counter Testing (Class 100 to Class 100,000)
  • HEPA & ULPA Filter PAO/DOP Aerosol Integrity Leak Testing
  • Air Flow Velocity, Volume & Air Change Rate (ACH) Calculation
  • Room Differential Pressure, Temperature & Relative Humidity Mapping

Thermal Mapping & Autoclave Sterilization

Multi-channel thermal mapping (12 to 36 sensors) for steam autoclaves, dry heat sterilizers, stability chambers, and 24-hour cold room validation with F0/FH lethality values.

  • Autoclave Heat Penetration & Heat Distribution Validation
  • Dry Heat Sterilizing Tunnels & Depyrogenation Ovens
  • 24-Hour Thermal Mapping of Cold Storage & Warehouses
  • Stability Chambers, Incubators & Ultra-Low Freezers (-80°C)

Equipment Qualification Protocols (DQ/IQ/OQ/PQ)

Preparation and execution of formal qualification protocols for pharmaceutical manufacturing equipment, water systems, and process utilities.

  • Design Qualification (DQ) & User Requirement Specification (URS)
  • Installation Qualification (IQ) & Operational Qualification (OQ)
  • Performance Qualification (PQ) & Re-validation Scheduling
  • Tablet Presses, Liquid Filling Lines & Blister Packaging Machines

Compressed Air & Pure Utility Validation

Comprehensive purity testing for compressed air systems, nitrogen loops, pure steam, and Purified Water (PW) / Water for Injection (WFI) systems.

  • Compressed Air Dew Point & Moisture Content Analysis
  • Residual Oil Mist & Particle Contamination Testing
  • Pure Steam Non-Condensable Gas & Superheat Testing
  • WFI & PW Loop Temperature & Conductivity Validation
FREQUENTLY ASKED QUESTIONS

Cleanroom & Validation FAQs

Answers to common queries regarding regulatory compliance, validation protocols, and testing standards.

Which international standards govern your cleanroom validation process?
We perform cleanroom validation strictly according to ISO 14644-1:2015 (Classification of air cleanliness), ISO 14644-2, ISO 14644-3 (Test methods), EU-GMP Annex 1, WHO TRS guidelines, and US FDA cGMP requirements.
What is involved in DQ, IQ, OQ, and PQ validation protocols?
Design Qualification (DQ) verifies design specs; Installation Qualification (IQ) confirms correct system installation; Operational Qualification (OQ) verifies functionality across operating ranges; and Performance Qualification (PQ) ensures consistent long-term performance under actual production conditions.
How long does a thermal mapping study take for autoclaves or stability chambers?
Thermal mapping study duration ranges from 24 hours for sterilization cycles up to 72 hours for continuous environmental rooms and cold rooms, utilizing multi-point high-precision data loggers.
Are your validation reports accepted by DRAP (Drug Regulatory Authority of Pakistan)?
Yes, 100%. Our validation protocol binders and summary reports are engineered specifically to pass DRAP inspector audits, ISO 17025 surveillance audits, and international customer quality inspections.
What test equipment is used for PAO HEPA filter leak testing?
We use NIST-traceable linear digital aerosol photometers and calibrated aerosol generators with Polyalphaolefin (PAO-4) or Emery 3004 reagents to detect pinhole leaks exceeding 0.01% downstream concentration.
How frequently must cleanrooms be re-validated?
ISO 14644-2 recommends maximum intervals of 6 months for Grade A/B (ISO Class 5) sterile production areas, and 12 months for Grade C/D (ISO Class 7/8) non-sterile cleanrooms.

Planning a new cleanroom installation or scheduled validation audit?

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