Clean Room Guide Main
Clean Room Guide Main
Clean Room Guide Main
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1/19/23, 2:26 PM Clean Room
Selection ISO 14644-1 airborne particulate cleanliness classes for cleanrooms and clean zones:
ISO Classification number Maximum concentration limits (particles/m^3 of air ) for particles equal to
and larger than the considered sizes shown below:
Class Clean rooms of class 10000 are used for mounting procedures in hydraulic or pneumatic equipment and on some occasions
10000: are also used within the food and beverage industry. Class 10000 cleanrooms are also commonly used within the
pharmaceutical industry.
Class This classroom class is used by many industries, for example when working with optical products, when building large
100000: electronic systems based on smaller components, when building hydraulic and pneumatic systems and also within the food
and beverage industry. The pharmaceutical industry also makes frequent use of this class of cleanrooms.
ISO 14644-2 Specification for testing and monitoring to prove continued compliance:
This part of the overall standard specifies requirements for periodic testing of cleanrooms and associated controlled environments to prove their
continued compliance with ISO14644-1, and for the designated class of environmental cleanliness.
Air Changes per hour= Average airflow velocity* x room area x 60 min/hr
Room Volume
Filter Class Overall Value Overall Value Leak test Efficiency (%) Leak test Penetration (%)
Efficiency (%) Penetration (%)
H 10 85 15
H 11 95 5
H 12 99.5 0.5
Floors, Walls and other Contact Cleaning Surface Counting of Particles, and micro-
Surfaces (and ,where required, organisms
disinfection)
People Airborne Contact Cleanroom garments Surface counts; inspection for tears; particle
Gloves penetration testing Inspection for punctures
Surface contamination counts
Machines Airborne Contact Ventilation Design of Air extract rates and airflow patterns Surface
machine cleaning or contamination
disinfection
Raw materials Mainly contact Control of manufacturing Particle and bacterial counts within, or on,
of raw materials the materials Filtration systems Sterilisation
Cleaning if solids, or system
filtration if fluids
sterilization
Containers and Mainly Contact Control of their Particles and microbial Counts on surface
packaging composition and Sterilisation Systems
manufacturing
environment sterilization
Apparel Type
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1/19/23, 2:26 PM Clean Room
2 piece suit NR NR NR
Coverall R R R
Shoe Cover NR NR NR
Boot R R R
Special Footwear AS AS AS
Hair Cover(bouffant) R R R
Hood AS R R
Powered headgear AS AS AS
Woven gloves NR NR NR
Barrier gloves R R R
Inner suit AS AS R
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