A comprehensive bibliographic study on foodborne outbreaks in the western world, on the main food safety problems in the food industry, and on the implementation of Hygienic Design in the food industry has been carried out. An alarming scenery appears: foodborne infections cause several mil- lions cases of human illness and many thousands deaths annually in the western world. On the other hand the most part of the reported cases of foodborne outbreaks are attributable to poor handling at the home or at retail food establishments rather than failures at the food processing level. The study shows that the lack of hygienic design of equipment is probably the most important food safety problem in the shelf-stable food industry. Shelf-stable foods are not high-risk foods, anyhow they can be the cause of botulism outbreaks, really not so rare public health emergencies. Unfortunately Hygienic Design is an unfamiliar issue and the aware- ness of the food industry about the importance of this topic is quite low. Thermal processing is one of the most important operations in food processing but, also for this equipment typology, the manufac- turers are far from a really scientific approach to the design, which obviously includes also the Hygienic Design. Moreover, from the aca- demic point of view, a few articles on this topic are available in the literature and are mostly related to CFD simulation of cleaning pro- cesses. The most part of available documents are from the organiza- tion European Hygienic Engineering and Design Group, a consortium of equipment manufacturers, food industries, research institutes and public health authorities, working since 1989. A huge lack of knowledge and research on the above said topics has been found and so a whole approach for the assurance of the Food Hygiene has been developed in this PhD thesis. The case of aseptic processing and packaging systems has been handled. Several proce- dures, tools and methods have been developed. Firstly it is necessary to have regard to the in force regulations (not so obvious), and the use of available standards and guidelines should be expected. - A check list for the evaluation of compliance of aseptic processing and packaging systems to the European and US regulations, the European and international standards and the European and international guidelines has been developed. Secondly a scientific knowledge about the physical phenomena in- volved in the process should be desirable.- A method (software + measuring cell) for the determination of the most important physical property of foods (thermal diffusiv- ity) involved in heat treatment has been developed.- A procedure (simple software also developed) for the correct de- sign and setting of the flow diversion device, a critical point of aseptic processing and packaging systems, has been developed. Thirdly the opportunity to perform validation procedure should be always taken into account.- A method for the validation of aseptic packing machines has been developed.The created instruments have been tested on real equipments and products. A good survey on the implementation of Hygienic Design in the Italian food industry is the result of the wide use of the check-list. In some case the developed approach allowed to solve food hygiene problems. Since there is the need, not only for scientific research, but also for dissemination and training, the Italian Section of the EHEDG has been set up in Parma, which is, at the present time, also the site of the European Food Safety Authority. Several companies have been involved and the activities of the section are increasing and spreading.
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