To control the bioburden in your cleanroom you will need to use disinfectants; these are chemicals that have properties that can kill micro-organisms. You will probably need to use two or more disinfectants in rotation, and this is why the process of killing micro-organisms in your cleanroom is called rotational cleaning.
Annex 1 – Manufacture of sterile medicinal products - Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary use, point 61, states the following:
“The sanitation of clean areas is particularly important. They should be cleaned thoroughly in accordance with a written programme. Where disinfectants are used, more than one type should be employed. Monitoring should be undertaken regularly in order to detect the development of resistant strains.”
"Annex 1: Manufacture of Sterile Medicinal Products," Good Manufacturing Practice (GMP) Guidelines (Brussels, Nov, 2008).
Download the guide to selecting the right agents for rotational cleaning
What is Rotational Cleaning?
EU GMP Annex 1 states that more than one type of disinfecting agent with different modes of action s...Read more