STANDARD REQUIREMENTS OF ENVIRONMENT FOR DRUG PRODUCTION ( Max.

values are given )

COUNTRY ASEAN GMP U.S. - USP 26 ISO 14644-1 JP 14 JP 14
DOCUMENT & CPOB (at rest) (operational)

TOTAL (0.5 mikron) (0.5 mikron) (0.5 mikron) (0.5 mikron) (0.5 mikron)
PARTICULATE Class1 : 3.500/m3 * Class M3.5 : ISO 5 : CLASS A: CLASS A:
COUNT Class1 : 3.500/m3 3.530/m3 or 100/ft3 3.520/m3 3.530/m3 * 3.530/m3 *
Class2 : 350.000/m3 Class M5.5 : ISO 7 : CLASS B: CLASS B:
Class3 : 3.500.000/m3 353.000/m3 or 10.000/ft3 352.000/m3 3.530/m3 353.000/m3
Class M6.5 : ISO 8 : 3.520.000/m3 CLASS C : CLASS C :
3.530.000/m3 or 100.000/ ft3 353.000/m3 3.530.000/m3
CLASS D : CLASS D :
3.530.000/m3 Not defined
(5 mikron) (5 mikron) (5 mikron)
Class1 : 0/m3 * Class M3.5 : ISO 5 :
Class1 : 0/m3 0/m3 or 0/ft3 29/m3
Class2 : 2.000/m3 Class M5.5 : ISO 7 :
Class3 : 20.000/m3 2.470/m3 or 70/ft3 2.930/m3
Class M6.5 : ISO 8 :
24.700/m3 or 700/ft3 29.300/m3
AIRBORNE Class1 : < 1 CFU/m3 * Class M3.5 : CLASS A: < 1 cfu/m3
VIABLES Class1 : 5 CFU/m3 Class2 < 0.1 CFU/ft3 or < 3 CFU/m3 CLASS B: < 10 cfu/m3
: 100 CFU/m3 Class M5.5 : Not stated Not stated CLASS C: < 100 cfu/m3
Class3 : 500 CFU/m3 < 0.5 CFU/ft3 or < 20 CFU/m3 CLASS D: < 200 cfu/m3
Class M6.5 :
< 2.5 CFU/ft3 or <100 CFU/m3
SURFACE VIABLE Class M3.5 : 3 CFU/c.plate CLASS A : < 1 cfu/c.plate
Not stated Class M5.5 : Not stated Not stated CLASS B : < 5
5 CFU/c.plate(except floors) cfu/c.plate
10 CFU/c.plate( floors) CLASS C : < 25
cfu/c.plate
AIR VELOCITY 0.3 m/s vertical * 0.45 Not stated Not stated Not stated Not stated
CLASS D : < 50
(under laminar)* m/s horizontal *
cfu/c.plate