目录简介 | 5 Plants and Workshops
5.1 Design and layout
5.1.1 The relevant provisions in GB 12693 shall be met.
5.1.2 Plants, workshops and corresponding-manufacturing facilities & equipments shall be properly designed, constructed and planned to prevent microorganism breeding and contamination, especially the contamination of salmonella and E. sakazakii (Cronobacter species), simultaneously to avoid or manage to reduce the existence and the growth of these bacteria in harborage sites. During design, the following factors shall be considered to avoid microorganism growth:
5.1.2.1 During design, wet area and dry area shall be insulated and separated; the contamination due to the movement of person, equipment and material shall be effectively controlled to prevent salmonella and E. sakazakii entering into cleaning work area.
5.1.2.2 Proper drainage facilities shall be equipped; the ground shall be flat and kept in a rational slope to preventing water logging; besides, in cleaning work area, measures shall be taken to prevent water condensation.
5.1.2.3 Processing materials shall be free from improper piling so that the places being difficult to be cleaned will not be resulted.
5.1.2.4 Wet cleanness process shall be designed properly. In dry area, un-proper wet cleanness process shall be avoided so as not to lead to the growth and transmission of salmonella and E. sakazakii.
5.1.2.5 The space left due to various pipelines and cables through the floor slab, ceiling and wall face of constructions as well as by holing shall perfectly be enclosed and sealed.
5.1.3 The interior design and layout of the places to manufacture powdered formulae for infants and young children shall be proper and according to manufacturing process requirements and hygienic cleanness requirements.
5.1.4 The operation, such as the operation from drying (or post-drying) to filling and package sealing, beyond post-sterilizing in dry processing region, shall be carried out in cleaning work area
5.1.5 Work areas shall be divided into commonly work area, quasi-cleaning work area and cleaning work area in principle according to manufacturing process and the requirements of hygiene & quality. Independent atmospheric purification system with defecator (being kept in positive pressure) shall be installed in cleaning work area.
5.1.6 The work areas with different clean levels shall be physically and effectively separated. Positive pressure shall be kept in cleaning work area versus other areas to prevent unpurified air entering into cleaning work area and causing cross contamination.
5.1.7 The exit and entrance from or into cleaning work area shall be properly controlled and limited to avoid or reduce bacteria contamination. Corresponding measures shall be taken to prevent cross contamination due to person, raw material, packing material, rubbish and equipment etc. exiting and entering from or into cleaning work area, e.g. dressing room is arranged for workers to replace their work clothes, shoes and wear their shoe covers; exclusive logistics corridor as well as rubbish passage are arranged. Proper air filtering system shall be designed and set up for the raw materials or products which are entered into cleaning work area through pipelines.
5.1.8 The cleanness level of each work area shall meet the air cleanness requirements for processing powdered formulae for infants and young children. The air cleanliness in cleaning work area and quasi-cleaning work area shall meet the requirements in Table 1 and be inspected regularly. |
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