Modular Cleanrooms for Medical Device & Consumable Production
Engineered for ISO 13485, GMP, and FDA compliance in sterile device manufacturing.
Products We Support
Tailored Cleanroom Environments for:
✔ Surgical Masks & N95 Respirators
✔ Syringes, Catheters & IV Sets
✔ Rapid Diagnostic Test Kits (COVID, Flu, etc.)
✔ Disposable Gloves, Gowns & Drapes
✔ Blood Collection Devices & Tubes
✔ Plastic Molding for Medical Components
✔ Ophthalmic & Dental Consumables
Designed to support Class I, II, and III device production under ISO and GMP standards.
Why Choose KS Cleanrooms for Medical Device Manufacturing?
Certified Cleanroom Systems for Regulatory Compliance
✔ ISO Class 7–8 Cleanroom Solutions – Ensures low particulate environment
✔ Modular Wall & Ceiling Panels – With antibacterial and anti-static coatings
✔ Positive Pressure & HEPA Filtration – Keeps critical zones contaminant-free
✔ BMS/EMS Integration – Real-time temperature, humidity, and differential pressure monitoring
✔ Compatible with Clean Injection Molding, Assembly Lines, and Packaging Systems
✔ Supports Validation & Documentation – For ISO 13485, cGMP, and FDA audits
Our solutions are deployed by top-tier medical device manufacturers across Asia, Europe, and the Middle East.
|
Component |
Description |
| Cleanroom Class | ISO Class 7 or 8 (optional Class 6 for sterile zones) |
| Panel Type | PU / Rockwool / Aluminum Honeycomb, with PVC/PVDF coating |
| Flooring | Antibacterial vinyl / Conductive epoxy |
| Lighting | Flicker-free, cleanroom-grade LED (IP65) |
| HVAC System | Integrated with prefilter, HEPA, and airflow zoning |
| Gowning Area | Full anteroom & pass box integration |
| Documentation Support | As-built drawings, DQ/IQ/OQ templates for validation |
Project Cases / Gallery
Medical Cleanrooms in Action
KS has supported mask factories, disposable syringe manufacturers, and rapid test kit producers with fully certified modular cleanroom installations.
