Hygienic design in the life science industry: Strict implementation of hygienic design requirements described by way of stainless steel furniture

A hygienic manufacturing environment is a prerequisite in life science and food & nutrition industries in order to maintain product sterility and minimise reject rates due to contamination. Product quality is primarily impaired by microorganisms, but also by other forms of contamination such as particles and chemical residues. To minimise the risk of product contamination during the manufacture, operating utilities used in the production environment should not represent a source of contamination. The hygienic design of equipment and the types of materials used for housings, shelves and joints require special consideration. The EHEDG design recommendations as well as other guidelines for hygienically designed utilities used in the food industry can be directly applied to the life science industry and are being implemented more frequently. The fundamentals of the recommendations are described in detail in this paper based on a qualification and optimisation "tested device" project on a stainless steel utility.