Sterility is a quality feature of the environment of cleanroom class A/ISO 5 for the production of aseptic products. As the rooms in cleanroom class A/ISO 5 are generally devices/systems such as RABS or isolator technologies,
the suitability for the manufacture of aseptic products must be proven by means of qualification. The regulatory requirements are examined, the key statements are summarized and the path to qualification/validation of the cleanroom class is shown,
to carry out a final validation of aseptic filling (APS/Media Fill)