CE Cleanroom folder 1
GMP Good manufacturing guidelines Annex 1 Disinfe
ction– 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 surface contamination must be performed first). Cleaning programs should be effective in the removal of disinfectant 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 demonstrated 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 materials should be sterile We know the challenge in the different standards and classifications – our products and systems have been designed to handle these challenges. To ensure the same high quality every time, we work according to international standards – we need to be compliant.. Ask for our documentation! Cleanroom – classes 18001:2007 14001:2015 ISO 50001 6