Medical & Surgical Device Cleanrooms — GCC

Most device assembly runs in ISO 7 or ISO 8 cleanrooms under ISO 14644-1, while critical steps like exposing implants or sealing sterile barriers use ISO 5 with laminar HEPA airflow. The right class depends on bioburden limits and device risk. Pak Gusu designs graded cleanrooms matched to each process zone for Gulf manufacturers.

Yes. We build cleanrooms designed to meet ISO 13485 and EU-GMP Annex 1, with documented pressure cascades, HEPA filtration and qualification records. This supports your device registration with regulators such as Saudi SFDA, UAE MOHAP and Qatar MoPH. Pak Gusu provides validation-ready documentation; the manufacturing licence remains held by your facility.

Yes. We manufacture in Pakistan and ship modular cleanroom systems, flush wall panels, doors, windows and pass boxes CIF or DAP to Gulf ports such as Jebel Ali, King Abdul Aziz Port Dammam and Hamad Port. On-site installation supervision is available at extra cost, coordinated with your local GCC contractor.

Bioburden is controlled by combining HEPA filtration, positive-pressure cascades, gowning and material airlocks with UV or wipe-down decontamination, plus flush, cleanable surfaces and routine disinfection. Together these limit viable microorganisms entering critical zones. Pak Gusu integrates decon pass boxes, flush wall systems and welded vinyl flooring to keep bioburden low.

A sterile barrier system, such as a Tyvek pouch, maintains device sterility until use. Sealing it in an ISO 5 critical zone under HEPA airflow prevents particle and microbial ingress before the seal closes. Pak Gusu designs ISO 5 packaging suites, compliant with ISO 14644, so the sterile barrier stays intact through final sealing.

A decontamination pass box transfers materials into a cleanroom without opening doors to the outside, reducing cross-contamination. Active units use HEPA-filtered air purges to clean item surfaces on entry, while dynamic interlocks prevent both doors opening together. Pak Gusu supplies active HEPA decon pass boxes, shipped across the GCC for medical and surgical device cleanrooms.