Legend - Medical Device Cleanroom
20 x 30 m / H 3.0 m / 600 m2 / ISO 7 cleanrooms + ISO 8 personnel
Walls & ceiling: white sandwich panels, 1.10 m joints (toggle transparent / hidden)
Cleanroom doors, 45° open, dark frame + full-height vision glazing
View windows 1400 x 2200, sill 600, 200 spandrel: slim black frames + near-clear glazing; 11 on the CR1 / CR2 east wall (6 CR2 + 5 CR1, evenly spaced), 3 on the Outer Packaging west wall; no north / south wall glazing
14 wall return louvers 1000 x 450, sill 50, horizontal blades, recessed into the wall opening directly below each view window
2 interlocked pass boxes 600 x 600 x 600, sill +900: stainless body, twin doors with vision glass, green interlock LED
HEPA terminals 610 x 610 / 1000 m3/h, H14, flush-recessed in the ceiling (no FFU)
400 x 400 supply down-outlets directly above each HEPA terminal
ceiling return grilles 400 x 400, near walls, louver blades, primary return path
Galvanised ducts 400 x 400: supply 3.15-3.55 m (light), return 3.55-3.95 m (dark), layers never cross
Central AHU on the north plant platform (outside the 20 x 30 m envelope) - always visible, supply / return risers butt flush onto the casing top
8 x injection moulding machines (IMM) in Cleanroom 1
Manual assembly under local ISO 5 laminar flow / semi-automatic assemblers
Personnel flow (cyan) / material flow (orange) arrows; blue arrows show top supply / top return air pattern
Drag to orbit · scroll to zoom · right-drag to pan
Ceiling / Air toggles the ceiling panel; it is hidden by default. HVAC / Ducts toggles only the duct network and air-pattern arrows (hidden by default so equipment reads clearly). HEPA terminals, supply outlets, return grilles and the AHU always stay visible.
Medical Device Cleanroom - Layout & Process Simulation
Envelope 20000 x 30000 mm (600 m2), clear height 3000 mm. Seven zones as per the hand sketch: Shoe Change, Gowning, Hand Wash & Sanitizing (north); Cleanroom 1 IMM and Cleanroom 2 Downstream (middle); Outer Packaging and the Buffer / Airlock in the south-east corner (south). Room sizes are derived from GMP / process requirements, not equal splits. Cleanroom observation glazing sits on the east wall only: 11 view windows with slim black frames and near-clear glass (6 evenly spaced in CR2, 5 in CR1), no north / south wall windows; the Outer Packaging west wall carries 3 view windows. Every exterior view window has a recessed 1000 x 450 low-level return louver below it (14 in total). The Outer Pack / Buffer partition has no view window. Both pass boxes are 600 x 600 x 600 mm. All goods enter through the buffer airlock D11 -> D08 -> D06; the former CR1 west-wall inlet is closed.
Room sizing rationale (indicative, medical-device GMP)
| Room | Size m | Area m2 | Design basis |
Suggested process flow (realistic, indicative)
| # | Step | Zone | Equipment / control |
Air balance - HEPA terminals / supply / return (NO FFU)
| Room | Grade | Area m2 | Vol m3 | ACH design | Req. m3/h | HEPA | Supply m3/h | ACH actual | Returns | Ret. cap | Status |
| Total | | | | | | |
Room schedule / pressure cascade
| Room | Size m | Area m2 | Grade | Pressure |
Terminal / grille coordinates (ceiling, m)