Cleanroom Validation & Qualification in Pakistan

What do IQ, OQ and PQ actually prove?

Qualification is a staged build-up of evidence. Each stage answers a different question, and you generally cannot pass a later stage until the earlier one is signed off.

• DQ (Design Qualification) — confirms the design itself (ISO class, airflow scheme, pressure cascade, finishes) meets the user requirement specification before anything is built. Pak Gusu produces the design package that feeds DQ.
• IQ (Installation Qualification) — verifies the room was installed as designed: panel and ceiling system, fan filter units, HEPA grades, ductwork, doors, interlocks, utilities and as-built drawings all match the specification.
• OQ (Operational Qualification) — demonstrates the room performs to specification at-rest: airflow volumes/velocity, air changes per hour (ACPH), HEPA integrity, room pressure cascade, recovery time and temperature/humidity all within limits.
• PQ (Performance Qualification) — confirms the room holds its classification in operation (in-use), with people and process running, often over repeated runs and including viable/microbial monitoring for GMP rooms.

Pak Gusu engineers the room and prepares the IQ/OQ/PQ documentation; your QA team or an accredited laboratory executes and certifies it. For the Gulf equivalent of this workflow, see our guide to cleanroom validation (IQ/OQ/PQ) in the Gulf.

Which tests are run, and what does each one prove?

The table below maps each qualification test to the governing standard and to the thing it actually demonstrates. ISO 14644-1 sets the classification limits; ISO 14644-3 specifies how the supporting tests are carried out.

Cleanroom qualification tests vs standard vs what they prove

Test	Standard	What it proves
Airborne particle count (classification)	ISO 14644-1	The room meets its ISO class (e.g. ISO 5–8) at the stated occupancy state — the core classification result.
Airflow volume / velocity & ACPH	ISO 14644-3	Supply air volume and air changes per hour match design — the engine behind contamination control.
HEPA/ULPA filter integrity (DOP/PAO scan)	ISO 14644-3 / EN 1822	No leaks in filters or seals; installed filters are sound at H13/H14 grade.
Recovery / clean-up time	ISO 14644-3	The room clears a particle challenge within the target time — evidence the ventilation works dynamically.
Room pressure differentials (cascade)	ISO 14644-3 / EU-GMP Annex 1	The pressure hierarchy between rooms protects the critical zone and prevents back-flow.
Temperature & relative humidity	ISO 14644-3	The room holds the T/RH window the process and comfort require.
Airflow visualisation (smoke study)	EU-GMP Annex 1	Unidirectional flow and protection of the critical zone in Grade A/ISO 5 areas (for aseptic processing).
Containment / induction leak (where required)	ISO 14644-3	Confined leakage between adjacent zones is within limits — relevant for negative-pressure or contained rooms.

New to these terms? The cleanroom glossary defines ISO class, ACPH, HEPA grades and pressure cascade in plain language, and our blog explains the ISO 14644 cleanroom classes.

ISO 14644-1 classification and the three occupancy states

ISO 14644-1 classifies a cleanroom by the maximum permitted concentration of airborne particles at defined size thresholds. The result depends on which occupancy state the count is taken in, and a credible qualification states it clearly:

• As-built — room complete, services on, no equipment or people.
• At-rest — equipment installed and running, no personnel.
• In-operation — equipment running with the normal number of people present and the process active.

The number of sampling locations and the sampled air volume scale with room area and the target class — a small ISO 7 gowning room needs fewer points than a large ISO 5 fill suite. EU-GMP Annex 1 maps its Grades A–D to ISO classes (for example Grade A corresponds to ISO 5 at rest and in operation), which matters for pharmaceutical and sterile facilities. Because class drives filter coverage, ACPH and HVAC sizing, it is one of the biggest cost levers — you can test that trade-off on the cleanroom cost calculator.

HEPA integrity, airflow and pressure — the ISO 14644-3 battery

ISO 14644-1 tells you the room is clean; ISO 14644-3 tells you why, and gives QA the evidence that the engineering is sound.

• HEPA/ULPA integrity (DOP/PAO scan): a challenge aerosol is introduced upstream and the downstream face of each filter and its seal is scanned. Any reading above the leakage limit is a defect to be repaired and re-scanned — this is a leak test, distinct from the factory efficiency rating. Our filters and fan filter units use EN 1822 H13/H14 media.
• Airflow & ACPH: measured velocities (for unidirectional/laminar flow zones) or supply volumes (for turbulent rooms) confirm the air-change rate the design relies on.
• Recovery time: a deliberate particle challenge is cleared and timed — proof the room self-cleans within target.
• Pressure cascade: differential gauges confirm the hierarchy that keeps the cleanest room positive to its surroundings (or negative, for containment), supported correctly by sealed doors and pass-through chambers.
• Temperature & RH: logged to confirm the room holds the process window.

Pak Gusu builds the room and its envelope — cleanroom panels, doors, FFUs and pass boxes — so these tests have the best chance of passing first time. Browse the full range on the products page.

What is in the validation-ready documentation pack?

This is where we are precise about our role. Pak Gusu does not issue your classification certificate — an accredited laboratory does — but we hand over the engineering documentation that makes qualification straightforward and defensible. A typical pack includes:

• User requirement and design basis (ISO class, ACPH, pressure scheme, finishes) supporting your DQ.
• As-built GA and services drawings, room schedules and the HVAC/airflow concept.
• Component datasheets and certificates of conformity — panels, HEPA filters (EN 1822 grade), FFUs, doors, lights, pass boxes.
• Factory acceptance test (FAT) records and material traceability.
• Draft IQ/OQ/PQ protocols and a qualification (traceability) matrix linking each requirement to the test that verifies it.
• Installation and operation/maintenance manuals.

From there your QA team or an accredited body executes the protocols and issues the certificate. If you need on-site help, installation supervision is available at additional cost — start the conversation via get a quote or review our services.

DRAP, GMP and PIC/S — the honest regulatory picture

For pharmaceutical and nutraceutical facilities in Pakistan, the regulator is the Drug Regulatory Authority of Pakistan (DRAP), which inspects manufacturing sites against GMP expectations aligned with EU-GMP and WHO guidance. Pakistan is a PIC/S applicant — not a full member — so DRAP's direction of travel is towards PIC/S-style GMP, but you should confirm current requirements with DRAP for your licence category.

Here is the boundary we hold: Pak Gusu designs and builds cleanrooms engineered to support your GMP/DRAP submission and documented to suit an audit. We do not claim to be "GMP certified" or "DRAP approved", because those are statuses your facility earns through inspection — not attributes of a supplier. The ISO 14644 classification certificate is issued by the accredited testing party you appoint. We give you validation-ready rooms and records; you and the accredited bodies close out compliance.

For the regulated sectors we serve most, see pharmaceutical & nutraceutical and food & beverage, or the full industries overview.

What to check before you commission validation (common concerns)

Buyers in Pakistan repeatedly get caught by the same gaps. Check these before you sign off a scope:

• Who certifies? Confirm in writing that classification testing will be done by an accredited laboratory and that the manufacturer is not claiming to issue the certificate itself. (We do not — by design.)
• Is the documentation traceable? Ask to see the qualification matrix linking every user requirement to a specific test. A pack without this is hard to defend in a DRAP audit.
• Is HEPA integrity a scan or just an efficiency claim? A genuine OQ scans each installed filter and seal for leaks (DOP/PAO) — it is not the same as the factory efficiency rating.
• Are occupancy states defined? Particle counts must state as-built, at-rest or in-operation; a result with no state is meaningless.
• Does the scope match your class? An ISO 8 room and an aseptic ISO 5 suite need very different test batteries (Annex 1 smoke studies, recovery, pressure mapping). Over- or under-scoping both cost you.
• Who handles re-tests and seasonal re-qualification? Filters age and seasons shift T/RH — agree the periodic re-qualification interval up front.

Cost is driven by ISO class, cleanroom area, ACPH, finishes, HVAC and validation scope rather than any single headline figure — model those factors on the cost calculator, then send the brief through get a quote.

Related pages

• Turnkey Cleanrooms Designed and Built in Lahore
• Cleanrooms for Karachi: Manufactured in Lahore, Delivered and Installed Across Sindh
• Cleanroom Design, Manufacture & Supply for Islamabad and Rawalpindi
• Cleanrooms for the GCC
• Cleanroom cost calculator
• Request a quote