What is Clean Room?
Clean room is a room or enclosed area where the ambient environment is controlled such as Impurity particles, temperature, air pressure, humidity, air flow patterns, vibration, light and microbial organisms.
CLEAN ROOM FOR MEDICINE ROOM
Clean Room Classification
with ISO 14644 Standard
| Class | Maximum Particles/m³ | FED STD 209E equivalent | |||||
| >0.1 um | >0.2 um | >0.3 um | >0.5 um | >1 um | >5 um | ||
| ISO 1 | 10 | 2 | |||||
| ISO 2 | 100 | 24 | 10 | 4 | |||
| ISO 3 | 1,000 | 237 | 102 | 35 | 8 | Class1 | |
| ISO 4 | 10,000 | 2,370 | 1,020 | 352 | 83 | Class10 | |
| ISO 5 | 100,000 | 23,7000 | 102,000 | 3,520 | 8,320 | 293 | Class 100 |
| ISO 6 | 1,000,000 | 237,000 | 102,000 | 35,200 | 8,320 | 2,930 | Class1,000 |
| ISO 7 | 352,000 | 83,200 | 2,930 | Class 10,000 | |||
| ISO 8 | 3,520,000 | 832,000 | 29,300 | Class 100,000 | |||
| ISO 9 | 35,200,000 | 8,320,000 | 293,000 | Room Air | |||
Clean Room Fundamental
(Non-Laminar Flow)
| Achievable Class | 1,000(M4.5) | 10,000(M5.5) | 100,000(M6.5) | Avoid |
|---|---|---|---|---|
| Room size (m2) | 100 | 300 | 500 | large square room |
| Room aspect ratio | Narrow | 3:1 | 2:1 | |
| Room height (m) | Min. 3 | Min. 2.75 | Min. 2.25 | |
| Area per occupant (m2) | 20 | 10 | 5 | |
| Equipment in room | Minimum | 30% Floor | 50% Floor | |
| Occupant activity | Sedentary | Occasional movement | Constant activity | Frivolous activities Streer clothes |
| Traffic in/out per hour | 1-2 | 2-6 | more than 6 | |
| Occupant properly attired | Full-gowns | Smocks | Smocks | |
| Particle generation in room | Miniature | Slight | Considerable | |
| Thermal updrafts | none | Slight | Considerable | |
| Housekeeping | Meticulous | Good | Mediocre | |
| Room pressure (Pa) | 10-15 | 10-15 | 5-10 | None |
| Air changes per hour | 40-120 | 20-40 | 10-20 | |
| Air lock | A | 2-6 | 2-6 | |
| Clean air inlets as % of ceilling area | 20-50 | 10-20 | 5-10 | Floor Ceilling Single |
| Clean air inlet locations | Ceilling | Ceilling | Ceilling or high sidewall | |
| Terminal velocity at clean air inlet | 0.15-0.45 (m/s) | Low sidewall | Sidewall | |
| Wall return spacing | Continuouse on all 4 wall | Intermittent on long on | Non-uniform | |
| Max. horizontal distance to return | 3 m | long | 9 m | |
| Return face vriocity (m/s) | 0.5-1 | 6 m 1-2.5 |
2.5 | |
| Prefilters | Doors open No schedule | |||
| – Frist Stage** | 50% dust spot eff. F5 | 90% dust spot eff. F4 | 80% dust spot eff. F4 | |
| – Second Stage | 90% dust spot eff. F8 | 80-90% dust spot eff. F7 | 80-90% dust spot eff. F7 | |
| Prefilter maintenance and Inspection | Min.99.999% @0.3μm H14 | Min.99.99% @0.3μm H10 | Min.95% @0.3μm H10 | |
| Final filter Routine particle count interval | Monthly | Monthly | Quarterly |
| Achievable Class | 1 and 10(M1.5and M2.5) | 100(M3.5) |
|---|---|---|
| Area per occupant (m2) | 40 | 30 |
| Occupants properly attired | Full gowns | Full gowns |
| Occupant activity | minimum | minimum |
| Equipment in room | minimum | minimum |
| Housekeeping | Meticulous | Meticulous |
| Room pressure | 15 Pa | 15 Pa |
| Air changes per hour | 500-600 | 500-600 |
| Air lock | Yes | Yes |
| Clean air inlets as % of ceilling area | 90-100% | 90-100% |
| Clean air inlet locations | Ceilling | Ceilling (wall) |
| Terminal velocity at clean air inlet (m/s) | 0.3-0.45 m/s | 0.3-0.45 m/s |
| Return locations | Perforated floor | Low Level or floor (Opposite wall 0.45 m/s) |
| Prefilters | ||
| 1.Frist Stage** | 30% dust spot efficiency F5 | 50% dust spot efficiency F5 |
| 2.Second Stage | 95% @ 0.3μm H10 | 90% @ 0.3μm H10 |
| Prefilter maintenance and inspection Final filter | Monthly Min.99.9995% on @0.12μm (Class 10) U14 Min.99.99995% on @0.12μm (Class 10) U14 |
Monthly Min.99.999% on @0.3μm H14 |
| Routine particle count interval | Daily | Weekly |
CLEAN ROOM WORK PRINCIPLE
AHU WORKING PRINCIPLE FOR CLEAN ROOM
