scope:

This guideline applies to aseptic filling plants and their peripherals designed for filling and sealing commercially sterile beverages and milk-based drinks in packaging which has been pre-sterilised or which has been formed and sterilised in the filling plant in a manner which prevents recontamination as per Section 5. This includes:

• fruit juices and fruit-juice drinks
• flavoured waters
• milk-based drinks
• energy and sport drinks
• tea-based drinks
• concentrates and syrups
• beer-based mixed drinks and alcohol-free beerbased mixed drinks (optional)

This guideline additionally applies to all associated machinery and equipment, as well as the filling plant environment.

Aseptic filling plants for pharmaceuticals are not covered by this guideline because concepts and requirements within the pharmaceutical industry differ from those of the food and drinks industry. Please refer to guideline VDI 4066 Part 4 (in preparation) for guidance on the filling and packaging of dairy products.

All guarantees of performance within the sterile zone must be based on verifiable factors. Minimum hygiene requirements for the sterile zone of a filling plant must be defined in order to separate aseptic machines from other filling equipment.

The sterile zone includes all system components which come into direct or indirect contact with sterile product or sterile packaging.

The plant environment must satisfy the stringent hygiene requirements of the plants described in this guideline. Criteria for this are defined in this guideline.

The piping system, including measurement sensors, valves and fittings, should comply with the recommendations of the European Hygienic Engineering & Design Group (EHEDG) and aseptic requirements, and have a positive pressure drop (applies only to primary circuits). The processes used must be capable of effectively killing specific microorganisms.

These microorganisms are to be defined in terms of microbial type, prior contamination, resistance behaviour, product parameters and installation site.

All system components must be designed to ensure that, when used as intended, technical malfunctions in the sterile zone of the filling plant do not result in product contamination. In the event of such a malfunction, however, contaminated packages must be identified and rejected. Furthermore, "non-sterile" status must then be indicated to activate the resanitisation process.

Suitable technical and organisational measures should be used to minimise the microbial prior contamination of the packaging and the plant environment so as to ensure aseptic operation of the plant.

Cleaning products and disinfectants for external and internal hygiene control must comply with aseptic requirements and be suitable. The type of beverage, the microorganisms and their resistance behaviour must be taken into account when designing thermal product treatment systems (flash pasteurisation and UHT).

A quality management system will ensure that preventative organizational measures are in place and statutory requirements are complied with. The management system should include an HACCP concept to be drawn up by the plant operator.

The requirements to be met must be defined as early as in the design phase.

This guideline provides directions for design, construction and operation of plants for the hygienic processing (see Section 4) and for the aseptic filling of beverages and milk-based drinks that are sensitive to microbiological spoilage, without the use of preservatives and cold sterilisation agents or other microbial inactivation measures such as hot filling after sealing the container.