The fundamental design principles of hygienic systems remain the same whether producing pharmaceuticals, vaccines or food and drinks. Controlling product quality and possible contaminants is foremost in the processing and engineering design approach to ensure that the product is safe for use. Contamination sources can be grouped into three main categories: physical contaminants, chemical contaminants and biological contaminants which includes microbial contaminants. Physical contaminants may be introduced to the process via raw materials, packaging, the surrounding environment or from the manufacturing equipment. The simplest barrier to physical contamination is to use closed process systems wherever possible. Separation techniques such as filtration, sieves and centrifugation are used routinely to control this. Additionally, human interventions are ideally kept to a minimum to avoid contamination from hair, skin particles and contact with clothing.
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