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Cleanroom: As the name itself indicates, A cleanroom is a room in which the concentration of airborne Particle is controlled. Cleanroom applications are mainly in, Pharmaceutical industry, Hospitals, Biotech industry, Semiconductor industry, Microelectronic industry etc.
Clean rooms are classified according to following standards:
• ISO 14644-1
• Federal Standards (FS 209)
• European standards
According to ISO 14644-1 : ISO classifies clean rooms into following
• ISO 1
• ISO 2
• ISO 3
• ISO 4
• ISO 5
• ISO 6
• ISO 7
• ISO 8
• ISO 9
In ISO there are 9 classes of the clean rooms from ISO 1 to IOS 9. ISO 1 is cleanest from all classes of ISO and ISO 9 is least clean or dirtiest from all ISO classes but cleaning level of ISO 9 is superior to a regular room. In pharmaceutical Industries following ISO, classes are generally required,
• ISO 5
• ISO 6
• ISO 7
• ISO 8
According to FS 209: According to the federal standard, FS 209 Clean rooms are classified as,
• Class100
• Class1000
• Class 10,000
• Class100,000
According to the EU GMP:
• Grade A
• Grade B
• Grade C
• Grade D
FS 209 is replaced by ISO 14644-1 but these terms are still in use. In ISO particle are taken as particles/m³ and in FS 209 particles were taken as particles/ft³.
A simple comparison of clean rooms classification for pharmaceutical industries is as follow,
ISO EU GMP FS
ISO 5 Grade A Class 100
ISO 6 Grade B Class 1000
ISO 7 Grade C Class 10,000
ISO 8 Grade D Class 100,000
