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A
cleanroom or
clean room is an environment with a controlled low level (specified by the number of particles per
cubic meter at a specified particle size) of environmental pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors.
Just like other construction projects it requires detailing in terms of quantity and specifications for structure & its finishes,Doors & viewpanels, HVAC, Lighting,Piping & Drainage.But it's totally precise specifications & stringent requirements makes the whole project-delivery to be very accurate & highest quality standards on actual site.
Structures for Cleanroom can be varying from traditional i.e bricks & concrete to advanced like Modular walls-PUF filled panel partitions.But advantage by using Modular-PUF filled partition panel is that, it has already very smooth finish causing no dust retention on its surface and it has flexibility to remove & reuse in other areas time-to-time which helps manufacture to meet their space requirements along with different products manufacturing cycles.Modular panels along with aluminum channels T-grids can be used to make false ceilings.
View panels & doors are very important part of a pharmaceutical manufacturing unit. Doors are provided with door closer & door seal to prevent Air pressure,humidity & temperature losses caused due to human traffic during production activity.
Paints can be of specific categories such as with antibacterial & anti-fungal properties like epoxy paints, Polyurethane (PU) paints.
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Flooring can be consist of monolithic smooth surface having coving at edges & corners (Both Horizontal & Vertical), which can be made up with protective coatings such as epoxy & PU coatings of specific grades & properties.
Lighting should be consist of concealed lines with fixtures compatible to specific requirements such as do not have shape or surface such that it can attract dust or other pollutants.Lighting fixtures should be enclosed and gasketed to maintain ceiling integrity and protect against infiltration of particles and airborne bacteria.
HVAC is undoubted governing discipline as far as cleanroom design is concern.So while designing the cleanrooms pressure, temperature & humidity are the main attributes to be kept in mind by the HVAC design professionals.Suitable air changes & airflow directions to be attain in order to achieve desired results.Role of Filters can not be ignored as they control contamination of circulated air within the clean rooms; HEPA & ULPA filters are widely utilized along with Humidifiers as per system design.
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There are different standards for definition of cleanroom such as ISO 14644-1,GMP-EU,BS 5295 & US FED STD 209E but US FED STD 209E is widely recognized one.In India, WHO guidelines along with GMP recommendations are considered mainly in approval process of a Cleanroom facility.
US FED STD 209E cleanroom standards
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Class
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maximum particles/ft3
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ISO
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≥0.1 µm
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≥0.2 µm
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≥0.3 µm
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≥0.5 µm
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≥5 µm
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equivalent
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1
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35
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7.5
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3
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1
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0.007
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ISO 3
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10
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350
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75
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30
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10
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0.07
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ISO 4
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100
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3,500
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750
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300
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100
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0.7
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ISO 5
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1,000
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35,000
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7,500
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3000
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1,000
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7
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ISO 6
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10,000
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350,000
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75,000
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30,000
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10,000
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70
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ISO 7
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100,000
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3.5×106
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750,000
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300,000
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100,000
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700
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ISO 8
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Specific features to be considered while designing cleanrooms:
- Class 100 means 100 particles/cu.ft at 0.5 micron or larger
- No more than two order clean room in neighborhood I.e. a class 100000 clean room can't be open in class 100 clean room.
- Pressure differential 0.03 in w.g for less critical & 0.5 w.g. for more critical clean room.
- lower pressure differential area collect dust from higher one.air flows(exfiltrate) from higher to lower pressure
- Space pressure above 0.5 in w.g. requires additional reinforcement for wall & ceiling
- Min.10% difference in supply & return CFM
- Temperature range- 66F to 70F
- Relative Humidity:45%+5%
Support Structure Space Requirements in General:
- Class 100000 - 300 sft
- Class 10000 - 500 sft
- Class 1000 - 700 sft
- Class 100 - 900 sft
Maintaining exact air balance between cleanroom facility is very tough challenges including tracing & eliminating air leakages in whole facility.
Cleanroom is not just a construction project but its a total controlled environment to achieve highest & desirable results by excellence in design & in construction as well.
Thanks
Dharmendra Vyas
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