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Case Study

Turn-Key Clean Rooms for Sterile Medical Device Factory

GMP Grade B, C & D compliant, ISO 13485 certified production facility — Production Line, Microbiology Lab and QC Lab

Al Riyad, KSAMedical Device
Location
Al Riyad, KSA
Industry
Medical Device
Application
Production Line, Microbiology Lab, QC Lab and Storage Area
Size
2,350 m² Clean Room Area, 1,980 m² CNC Area
Cleanroom Class
GMP Grade B, C & D + CNC
Standards
ISO 14644 (Cleanroom), ISO 13485 (Medical Device)
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Turnkey Project

All elements of the cleanroom project — design, engineering, construction management and project coordination — were delivered turnkey by our experienced team.

  • GMP Consulting
  • 2D & 3D Design
  • IQ, OQ, PQ
  • Pre-Validation

Clean Room

A total of 2,350 m² GMP Grade B, C & D clean room area was delivered. The facility includes a Production Line (Grade D), Microbiology Lab (Grade B) and QC Lab (Grade C), each designed to its respective classification. Completed in less than 25 days by our experienced team.

  • Dynamic Pass Box
  • Static Pass Box
  • Wide Vision Panels
  • 5 cm Radius Coving
  • IP65 Lighting
  • Step Over Bench
  • Service Columns

Laboratories

Fully equipped laboratory areas were delivered, including a GMP Grade B Microbiology Lab and Grade C Quality Control Lab. Modular laboratory furniture is designed by CAD precision — both functional and aesthetically pleasing.

  • Laminar Flow Cabinets
  • Biosafety Cabinets
  • Fume Hoods
  • Weighing Tables
  • Eye/Body Showers

HVAC System

The HVAC system features an economical, efficient design that provides the right environment for persons and equipment alike. Our dedicated experts carry out full-service design and build, from conception to completion — all under one roof.

  • CAV & VAV Systems
  • Control Panel
  • High Ceiling Diffusers
  • Fire Dampers
  • 11 AHUs and 3 Chillers
  • BMS System