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Our Service

Pheasants International provides pharmaceutical HVAC validation services in Pakistan for pharmaceutical, biotech, API, nutraceutical and medical device manufacturers.
HVAC validation in the pharmaceutical industry is the documented verification that a cleanroom air handling system consistently delivers the conditions its process requires — cleanliness class, air change rate, pressure cascade, filtration integrity, temperature and humidity — through a DQ, IQ, OQ and PQ sequence.
In a regulated facility the HVAC system is not building services. It is a critical process utility, and an inspector will treat it that way.

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Benefits

  • Reports your QA team can approve as received — written for review, not rework
  • Failures diagnosed, not just recorded — we build cleanrooms, so we know why a cascade collapses
  • Full qualification lifecycle — DQ, IQ, OQ and PQ documentation
  • Production downtime reduced — causes identified on site rather than after a second visit
  • Requalification intervals tracked so a due date is never missed
  • Tested against your URS, not a generic protocol
  • Inspection readiness — documentation structured for DRAP and international audit

How we work

Define

Review URS, room classifications, design intent, regulatory framework

Protocol

Write DQ, IQ, OQ and PQ protocols for QA approval before testing

Execute IQ

Verify installation against approved design and documentation

Execute OQ

Airflow, air changes, filter integrity, pressure cascade, recovery, temperature and humidity

Execute PQ

Performance verified in operation with personnel and equipment running

Document

Results, deviations and CAPA reporting compiled for QA review

Schedule

Requalification intervals set per ISO 14644-2 and your risk assessment

  • Airborne particle count and ISO 14644-1 classification, at rest and in operation
  • Air velocity, air changes per hour and airflow uniformity
  • Installed HEPA filter integrity testing (PAO/DOP)
  • Room pressure differential and full-facility cascade verification
  • Recovery and clean-up time testing
  • Airflow visualization (smoke) studies with video documentation
  • Containment leak testing between classified areas
  • Temperature and relative humidity mapping
  • Viable and non-viable environmental monitoring support
  • Lux and sound level verification
  • AHU qualification
  • DQ, IQ, OQ and PQ protocol writing and execution
  • Deviation and CAPA reporting
  • Requalification scheduling
  • Standards: EU GMP Annex 1 (2022) ·
  • ISO 14644-1/2/3
  • · WHO TRS
  • · US FDA cGMP 
  • DRAP

  • Pharmaceutical manufacturing

  • Sterile and aseptic production

  • API and bulk drug plants

  • Biotechnology facilities

  • Nutraceutical manufacturing

  • Medical device production

  • Veterinary pharmaceutical plants

  • Contract manufacturing organizations

  • QC and analytical laboratories

     

  • We design, build and validate cleanrooms — rare in Pakistan, and it changes what the report is worth
  • Protocols written for your QA team’s approval process
  • Airflow visualization with video documentation, as EU GMP Annex 1 expects
  • Root cause identified on site — which door seal, which return path, which damper
  • Full facility cascade tested, not room by room in isolation
  • Requalification managed as an ongoing programmed

Frequently Asked Questions

What is HVAC validation in pharma?

HVAC validation in the pharmaceutical industry is the documented verification that a cleanroom’s air handling system consistently delivers required cleanliness class, air change rate, pressure cascade, filtration integrity, temperature and humidity, through a DQ, IQ, OQ and PQ qualification sequence.

Which company provides pharmaceutical HVAC validation in Pakistan?

Pheasants International provides cleanroom qualification and HVAC validation across Pakistan for pharmaceutical, biotech, API and medical device manufacturers, testing to ISO 14644 and EU GMP Annex 1 with full IQ/OQ/PQ documentation.

What is the difference between DQ, IQ, OQ and PQ?

Design Qualification confirms the design meets requirements. Installation Qualification confirms it was installed as designed. Operational Qualification confirms it functions across its operating range. Performance Qualification confirms consistent performance under real production conditions.

Which HVAC guidelines apply to pharmaceutical facilities?

EU GMP Annex 1, ISO 14644 parts 1 to 3, WHO Technical Report Series guidance and US FDA cGMP are the principal references, with DRAP requirements applying locally in Pakistan.

How often must a pharmaceutical cleanroom be requalified?

ISO 14644-2 sets maximum intervals by classification, commonly 6 months for the cleanest grades and 12 months for others. Your risk assessment and GMP obligations may require more frequent testing.

Why is my cleanroom failing particle count?

Common causes are a HEPA filter leak, insufficient air change rate, pressure cascade failure allowing ingress from a dirtier area, gowning and personnel behaviour, and process-generated particles. Systematic testing isolates which.Common causes are a HEPA filter leak, insufficient air change rate, pressure cascade failure allowing ingress from a dirtier area, gowning and personnel behaviour, and process-generated particles. Systematic testing isolates which.