GMP Good manufacturing guidelines
Annex 1 Disinfection The disinfection of clean areas is particularly important. They should be cleaned and disinfected thoroughly in accordance with a written programme (for disinfection to be effective, cleaning to remove sur- face contamination must be performed first). Cleaning programs should be effective in the removal of disinfect- ant residues. Disinfectants and detergents should be monitored for microbial contamination; Disinfection dilutions should be kept in previously cleaned containers and should only be stored for defined periods.
Annex 1 Equipment The cleaning process should be validated so that it can be demon- strated that it: a) Can remove any residues that would otherwise create a barrier between the sterilizing agent and the equipment surfaces. b) Prevents chemical and particulate contamination of the product during the process and prior to disinfection. All critical surfaces that come into direct contact with sterile mate- rials should be sterile
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Cleanroom – classes
Current Standard
Prior Standard US Federal Standard 209E/D
DIN EN ISO 14644-1
EG/GMP
Maximum acceptable number of particles per cubic meter and particle size (cross section dimension) 0,1 µ m/m3 0,2 µ m/m3 0,3 µ m/m3 0,5 µ m/m3 1,0 µ m/m3 5,0 µ m/m3
KBE/m3t (colony forming units)
Cleanroom Class
Metric SI- unit m3
English unit ft3
Cleanroom Class
ISO 1 ISO 2 ISO 3 ISO 4 ISO 5 ISO 6 ISO 7 ISO 8 ISO 9
10
2
100
24
10
4
1000
237
102
35
8
M 1,5 M 2,5 M 3,5 M 4,5 M 5,5 M 6,5
1
10000
2370
1020
352
83
10
100000 23700
10200
3520
832
29
A/B
<1 10
100
1000000 237000 102000 35200
8320
293
(B)
1,000
352000 83200
2930
C
100
10,000
3520000 832000 29300 35200000 8320000 293000
(C)/D/E/F 200
100,000
18001:2007
14001:2015
ISO 50001
117
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