Vileda Professional Product catalogue 2022

121 GMP Good manufacturing guidelines Annex 1 Disinfection– revision ongoing 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 – revision ongoing 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 We know the challenge in the different standards and classifications – our products and systems has been designed to handle these challenges. To ensure same high quality every time, we work according international standards – we need to be in compliance too.. Ask for our documentation! 18001:2007 14001:2015 ISO 50001 Cleanroom – classes Current Standard Prior Standard DIN EN ISO 14644-1 EG/GMP US Federal Standard 209E/D Cleanroom Class Maximum acceptable number of particles per cubic meter and particle size (cross section dimension) Cleanroom Class KBE/m3t (colony forming units) Metric SI- unit m3 English unit ft3 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 ISO 1 10 2 ISO 2 100 24 10 4 ISO 3 1000 237 102 35 8 M 1,5 1 ISO 4 10000 2370 1020 352 83 M 2,5 10 ISO 5 100000 23700 10200 3520 832 29 A/B <1 M 3,5 100 ISO 6 1000000 237000 102000 35200 8320 293 (B) 10 M 4,5 1,000 ISO 7 352000 83200 2930 C 100 M 5,5 10,000 ISO 8 3520000 832000 29300 (C)/D/E/F 200 M 6,5 100,000 ISO 9 35200000 8320000 293000 INDEX