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Clean Room System

CERTIFIED BY ISO 9001 : 2015
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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