Pak Gusu manufactures cleanrooms in Lahore as the Pakistan technical partner of GUSU Purification (China) and exports validation-ready systems across the GCC. Every modular cleanroom, panel, door, pass-through and HVAC package we ship is designed to meet EU-GMP Annex 1 and ISO 14644 so your team can move straight into qualification rather than re-engineering a delivered shell. We do not hold a Gulf office or local facility licence, and we never claim regulatory approvals on your behalf — instead we give you a documentation pack and technical support engineered to make your own submission defensible.
Validation in the Gulf is regulator-specific: a pharmaceutical line bound for Dammam answers to the Saudi SFDA, a medical-device cleanroom in Dubai to the DHA and Dubai Civil Defence, an Abu Dhabi facility to the DoH, and a Doha site to Qatar's MoPH. We align the design qualification, factory acceptance evidence and on-site testing protocols to the framework you are filing under, then ship CIF Jebel Ali, King Abdul Aziz Port Dammam or Hamad Port. On-site installation and IQ/OQ/PQ supervision are available at extra cost; the facility licence and GMP certificate remain yours to hold.
What "validation-ready" actually covers
Validation-ready means the cleanroom arrives with the engineering evidence a Gulf inspector expects, not a bare envelope you have to reverse-engineer. Our pack maps the full V-model — DQ at design, IQ at install, OQ at commissioning and PQ in operation — to documented acceptance criteria.
Each delivery is supported by:
- Design Qualification (DQ) tying room layout, airflow direction and grade targets to EU-GMP Annex 1 and ISO 14644-1
- Installation Qualification (IQ) checklists for panels, doors, pass-throughs, HVAC, ducting and as-built drawings
- Operational Qualification (OQ) protocols for HEPA integrity, air-change rates, recovery time, pressure cascade and temperature/RH
- Performance Qualification (PQ) templates for sustained at-rest and in-operation particle counts
- Material and weld certificates, P&IDs and a traceability index for your submission file
What stays with you: the operational facility licence, the site GMP certificate, ongoing routine monitoring, and the signed validation conclusions. We supply the engineered evidence and protocols; your quality unit owns the approval.
Testing to EU-GMP Annex 1 and ISO 14644
Our cleanrooms are built and tested against the two frameworks GCC regulators reference most. EU-GMP Annex 1 governs sterile and aseptic pharmaceutical manufacturing, while ISO 14644 governs the airborne particle classification used across pharma, medical devices, healthcare and electronics.
We translate grade targets directly into testable numbers:
- EU-GMP Grade A and Grade B environments correspond to ISO 5
- Grade C corresponds to ISO 7
- Grade D corresponds to ISO 8
- Most GCC pharmaceutical and healthcare cleanrooms fall in the ISO 5 to ISO 8 band
On-site OQ/PQ testing — when you commission supervision — covers ISO 14644-1 particle classification, ISO 14644-3 HEPA filter installed-leak (DOP/PAO) testing, airflow velocity and uniformity, air-change-rate verification, room-recovery time, and the pressure differential cascade between adjacent grades. Annex 1 work additionally addresses unidirectional airflow visualisation and contamination-control-strategy alignment so your dossier reads consistently end to end.
Mapping documentation to each GCC regulator
There is no single "Gulf approval". Each authority reviews validation evidence in its own format, and our documentation is structured so it can be lifted straight into the relevant submission.
- Saudi Arabia (SFDA): EU-GMP-aligned validation evidence for pharmaceutical and medical-device facilities, packaged for SFDA inspection.
- UAE — Dubai (DHA) and Abu Dhabi (DoH): healthcare and device-facility cleanroom data supporting DHA and DoH facility review; MOHAP at federal level.
- UAE — Dubai Civil Defence (DCD): material fire-rating data, panel and door specifications, and layout drawings to support your DCD/civil-defence submission.
- Qatar (MoPH): classification and qualification evidence supporting Ministry of Public Health inspection.
Across all four we work to ISO 13485 (medical devices), WHO TRS guidance and GSO standards where they apply. We provide the engineered submission inputs and answer technical queries during review — the licence application, fees and approval sign-off remain with you and your local consultant.
Sectors, shipping and lead times
We supply validation-ready cleanrooms for sterile and non-sterile pharmaceuticals and nutraceuticals, medical and surgical device assembly, hospitals and healthcare suites (operating theatres, compounding, IVF), laboratories and R&D, food and beverage, and electronics manufacturing — each with grade targets matched to its regulatory pathway.
Logistics are planned around real Gulf gateways:
- CIF or DAP shipping to Jebel Ali (UAE), King Abdul Aziz Port in Dammam (KSA) and Hamad Port (Qatar)
- Sea freight from Karachi to Jebel Ali typically runs a short transit, with full project lead time driven by panel and HVAC build
- Manufacturing lead time of roughly 6 to 10 weeks depending on cleanroom size, grade and door/pass-through count, confirmed at order
- Optional mobilisation of an installation and IQ/OQ/PQ supervision team to site, quoted separately under your Incoterm and visa arrangements
Because the validation documentation is prepared in parallel with fabrication, the protocol pack travels with the shipment so qualification can begin as soon as the room is erected.
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Frequently Asked Questions
Common questions about cleanrooms, standards, cost and how Pak Gusu supplies and installs across the GCC.
Does Pak Gusu get our cleanroom approved by the SFDA or MOHAP?
No. We do not hold Gulf licences or approve facilities. We supply validation-ready cleanrooms with DQ/IQ/OQ/PQ documentation designed to meet EU-GMP Annex 1 and ISO 14644, plus technical support for your SFDA, MOHAP/DHA/DoH or MoPH submission. Your organisation holds the facility licence and GMP certificate and signs the validation conclusions.
What is included in your IQ/OQ/PQ validation pack?
The pack includes Design Qualification, Installation Qualification checklists with as-built drawings, Operational Qualification protocols for HEPA integrity, air-change rate, recovery and pressure cascade, and Performance Qualification templates for particle counts. Material and weld certificates plus a traceability index are included so your quality unit can file a complete, defensible submission.
Which standards do you test cleanrooms against?
We design and test to EU-GMP Annex 1 and ISO 14644. Grade A/B map to ISO 5, Grade C to ISO 7 and Grade D to ISO 8, with most GCC pharma and healthcare rooms in the ISO 5 to ISO 8 band. On-site OQ/PQ covers ISO 14644-1 classification, ISO 14644-3 HEPA leak testing, airflow, recovery time and pressure differentials.
Can you support a Dubai Civil Defence (DCD) submission?
Yes, on the engineering side. We provide material fire-rating data, panel and door specifications and layout drawings that support your DCD or civil-defence submission. We do not file the application or hold any civil-defence approval ourselves — your local consultant submits and the authority issues the clearance.
Do you ship to the GCC and where do you deliver?
Yes. We export from Pakistan CIF or DAP to Jebel Ali (UAE), King Abdul Aziz Port in Dammam (KSA) and Hamad Port (Qatar). The validation pack travels with the shipment so qualification can start once the room is erected. On-site installation and IQ/OQ/PQ supervision are available at additional cost, quoted under your chosen Incoterm.
What is the lead time for a validation-ready cleanroom?
Manufacturing typically runs about 6 to 10 weeks depending on cleanroom size, grade and the number of doors and pass-throughs, confirmed at order. Validation documentation is prepared in parallel with fabrication, so the DQ/IQ/OQ/PQ protocol pack ships with the cleanroom rather than afterward, letting your team begin qualification on arrival.
Cleanrooms supplied & installed across the GCC
Manufactured in Pakistan with GUSU (China) technology · shipped to Jebel Ali, Dammam & Hamad (CIF/DAP) · installation available across the Gulf.