All relevant equipment operating manuals, recommended maintenance schedules, as well as generally accepted good manufacturing practices etc. are followed.
The aseptic block needs to be able to run at nominal speed.
The upstream units need to be able to provide the required quantity and quality of packaging material needed for the microbiological validation.
The downstream units need to be able to handle the required quantity of filled and closed bottles produced during the microbiological validation in a way that ensures the integrity of the sealed bottles.
To run the validation, the packaging material must meet the correct specifications. (see appendix 2).
