GMP GOOD MANUFACTURING GUIDELINES GMP ANNEX 1 - CLEANING & DISINFECTION Mechanical cleaning programs should be effective in the removal of surface particles and residual disinfectant residues. Disinfectants and detergents should be regularly monitored for microbial contamination. Disinfection dilutions should be kept in clean containers and should only be stored for defined periods determined by the manufacturer. The disinfection of clean areas is particularly important. They should be cleaned and disinfected thoroughly in accordance with a formal contamination control program. For disinfection to be effective, mechanical cleaning to remove surface contamination must be performed first. GMP ANNEX 1 - EQUIPMENT The cleaning process should be validated to demonstrate that it; Can remove residues that would otherwise create a barrier between the sterilizing agent and the equipment surfaces 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 materials should be sterile We understand the challenges within the different standards and classifications required. Our systems and solutions have been designed to fulfill these challenges. To ensure standardized high quality results every time, we work according to international standards. As your cleaning partner, we must also follow compliance .
IEST INSTITUTE OF ENVIRONMENTAL SCIENCES & TECHNOLOGY IEST is the leading technical, non-profit membership association that connects professionals who impact the controlled environment industry. Founded in 1953, IEST is a multidisciplinary, international society with members who are internationally recognized for their contributions to the environmental sciences. They provide technical guidance through international standards, recommended practices, education programs developed by experts in the fields of contamination control, environmental testing, reliability and nanotechnology facilities. IEST’s 501(c)(3) none profit technical society is an ANSI accredited standards developing organization. It is also Secretariat of ISO/TC 209 cleanrooms and associated controlled environments. It is also an administrator of the ANSI accredited US TAG to ISO/TC 209. IEST is a founding member of the ANSI- accredited US TAG to ISO/TC 229 nanotechnologies.
CLEANROOM - CLASSES
18001:2007
14001:2015
ISO 50001
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 µm/m3 0,2 µm/m3 0,3 µm/m3 0,5 µm/m3 1,0 µm/m3 5,0 µm/m3
KBE/m3t (colony forming units)
Cleanroom Class
Cleanroom Class
Metric SI- unit m3
English unit ft3
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
10,000 100,000
13
3520000 832000 29300 35200000 8320000 293000
(C)/D/E/F 200
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