ห้องสะอาดคืออะไร?
ห้องสะอาด (Clean room) คือ ห้องหรือบริเวณปิดที่มีการควบคุมสภาวะแวดล้อมภายในห้อง ได้แก่ อนุภาคสิ่งเจือปน อุณหภูมิ ความดัน อากาศ ความชื้น รูปแบบการไหลของอากาศ การสั่นสะเทือน แสงสว่าง และ สิ่งมีชีวิตจำพวกจุลินทรีย์
CLEAN ROOM สำหรับห้องยา
การจำแนก Class Clean Room
ตามมาตรฐาน ISO 14644
| 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 | |||
หลักพื้นฐานในการออกแบบห้อง Clean Room
(ไหลเวียนแบบ 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 |
หลักการทำงานห้อง CLEAN ROOM
หลักการทำงาน AHU สำหรับห้อง CLEAN ROOM
