This guideline stresses the need to identify the sources of micro-organisms that may contaminate food in the packaging process, and to determine which contamination rates are acceptably low.

It clarifies the difference in risk of infection between aseptic processing and aseptic packing and recommends that aseptic packing machines be equipped with fillers that are easily cleanable, suitable for decontamination and bacteria-tight.

Requirements for the machine interior include monitoring of critical decontamination parameters. See also Doc 21 on challenge tests.