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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

ClassMaximum Particles/m³FED STD 209E equivalent
>0.1 um>0.2 um>0.3 um>0.5 um>1 um>5 um
ISO 1102
ISO 210024104
ISO 31,000237102358Class1
ISO 410,0002,3701,02035283Class10
ISO 5100,00023,7000102,0003,5208,320293Class 100
ISO 61,000,000237,000102,00035,2008,3202,930Class1,000
ISO 7352,00083,2002,930Class 10,000
ISO 83,520,000832,00029,300Class 100,000
ISO 935,200,0008,320,000293,000Room Air

Clean Room Fundamental

(Non-Laminar Flow)

Achievable Class1,000(M4.5)10,000(M5.5)100,000(M6.5)Avoid
Room size (m2)100300500large square room
Room aspect ratioNarrow3:12:1
Room height (m)Min. 3Min. 2.75Min. 2.25
Area per occupant (m2)20105
Equipment in roomMinimum30% Floor50% Floor
Occupant activitySedentaryOccasional movementConstant activityFrivolous activities Streer clothes
Traffic in/out per hour1-22-6more than 6
Occupant properly attiredFull-gownsSmocksSmocks
Particle generation in roomMiniatureSlightConsiderable
Thermal updraftsnoneSlightConsiderable
HousekeepingMeticulousGoodMediocre
Room pressure (Pa)10-1510-155-10None
Air changes per hour40-12020-4010-20
Air lockA2-62-6
Clean air inlets as % of ceilling area20-5010-205-10Floor Ceilling Single
Clean air inlet locationsCeillingCeillingCeilling or high sidewall
Terminal velocity at clean air inlet0.15-0.45 (m/s)Low sidewallSidewall
Wall return spacingContinuouse on all 4 wallIntermittent on long onNon-uniform
Max. horizontal distance to return3 mlong9 m
Return face vriocity (m/s)0.5-16 m
1-2.5
2.5
PrefiltersDoors open No schedule
– Frist Stage**50% dust spot eff. F590% dust spot eff. F480% dust spot eff. F4
– Second Stage90% dust spot eff. F880-90% dust spot eff. F780-90% dust spot eff. F7
Prefilter maintenance and InspectionMin.99.999% @0.3μm H14Min.99.99% @0.3μm H10Min.95% @0.3μm H10
Final filter Routine particle count intervalMonthlyMonthlyQuarterly
Achievable Class1 and 10(M1.5and M2.5)100(M3.5)
Area per occupant (m2)4030
Occupants properly attiredFull gownsFull gowns
Occupant activityminimumminimum
Equipment in roomminimumminimum
HousekeepingMeticulousMeticulous
Room pressure15 Pa15 Pa
Air changes per hour500-600500-600
Air lockYesYes
Clean air inlets as % of ceilling area90-100%90-100%
Clean air inlet locationsCeillingCeilling (wall)
Terminal velocity at clean air inlet (m/s)0.3-0.45 m/s0.3-0.45 m/s
Return locationsPerforated floorLow Level or floor (Opposite wall 0.45 m/s)
Prefilters
1.Frist Stage**30% dust spot efficiency F550% dust spot efficiency F5
2.Second Stage95% @ 0.3μm H1090% @ 0.3μm H10
Prefilter maintenance and inspection Final filterMonthly
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 intervalDailyWeekly

CLEAN ROOM WORK PRINCIPLE

AHU WORKING PRINCIPLE FOR CLEAN ROOM