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Clean rooms are defined as especially constructed, environmentally controlled enclosed spaces with respect to airborne particulates, temperature, humidity, air pressure, air flow patterns, air motion, vibration, noise, viable (living organisms) and lighting.
Particulate control includes:
– Particulate & microbial contamination
– Particulate concentration & dispersion
Classifications of clean rooms?
Generally clean rooms are classified in to the following types as per different guidelines:
– Schedule M: Grade A, Grade B, Grade C, Grade D
– USFDA (US 209E): Class 1, Class 10, Class 100, Class 1000, Class 10000, Class 100,000
– WHO 2002: Grade A, Grade B, Grade C, Grade D
– EU GMP: Grade A, Grade B, Grade C, Grade D
– ISO 14644-1: ISO-3, ISO-4, ISO-5, ISO-6, ISO-7, ISO-8, ISO-9
– Britian (BS 5295): Class C, Class D, Class E or F, Class G or H, Class J, Class K
– Australia (AS 1386): 0.035, 0.35, 3.5, 35, 350, 3500
– Germany (VDI 2083): 1, 2, 3, 4, 5, 6
