Medical Device GMP Cleanroom in Chonburi Thailand
Project Name: Medical Device GMP Cleanroom (Chonburi, Thailand)
Cleanliness Levels: Class 10,000 laboratory, Class 100,000 production workshop, and general areas
Wall Structure: Cleanroom-grade color steel panels
HVAC & Cleanroom Equipment: Central cleanroom HVAC system, purified water system, pass-through boxes, cleanroom doors, double-glazed cleanroom windows
Piping Systems: Stainless steel purified water piping, drainage system, and air duct system
Instrumentation: Venturi valves and differential pressure gauges
Electrical Systems: Power distribution cabinets, flat LED cleanroom lights, switches and sockets, UV lamps, and ozone systems
Flooring: Epoxy self-leveling flooring and PVC flooring
The medical device cleanroom workshop layout must align with the production process flow, ensuring the shortest possible routes to minimize backtracking and cross-contamination while optimizing personnel and material flow. Required facilities include personnel purification areas (outer garment storage, washroom, cleanroom gowning room, and airlock/buffer room) and material purification areas (outer packaging removal room, buffer room, and double-door pass-through boxes). Additional required spaces include a cleaning tool room, laundry room, temporary storage room, and workstation equipment cleaning room. Each room must be independent, and the workshop area must be commensurate with the production scale while meeting basic requirements. Air cleanliness levels must transition from higher to lower grades moving from the interior to the exterior of the workshop. The routing of return air, supply air, and purified water piping must be clearly marked, and temperature and humidity levels must meet production process requirements.
The facility must include a sterility testing room equipped with an independent purification HVAC system, separated from the production area; it requires a Class 10,000 environment with a localized Class 100 zone. The sterility testing room suite must include personnel purification areas, material purification areas, a sterility testing room, and a positive control room. Testing parameters include temperature, humidity, differential pressure, air change rates, particle counts, and airborne microbe counts (settle plates).