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§110.40 食品生产加工企业的设备及器具(Equipment and utensils)

   2011-04-19 348
核心提示:  原文后附带中文翻译,由食品伙伴网食品论坛网友gaoketian提供,食品伙伴网在此表示感谢!  110.40 Equipment and utensils

  原文后附带中文翻译,由食品伙伴网食品论坛网友gaoketian提供,食品伙伴网在此表示感谢!

      § 110.40   Equipment and utensils.

  (a) All plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. The design, construction, and use of equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces. Food-contact surfaces shall be corrosion-resistant when in contact with food. They shall be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds and sanitizing agents. Food-contact surfaces shall be maintained to protect food from being contaminated by any source, including unlawful indirect food additives.

  (b) Seams on food-contact surfaces shall be smoothly bonded or maintained so as to minimize accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms.

  (c) Equipment that is in the manufacturing or food-handling area and that does not come into contact with food shall be so constructed that it can be kept in a clean condition.

  (d) Holding, conveying, and manufacturing systems, including gravimetric, pneumatic, closed, and automated systems, shall be of a design and construction that enables them to be maintained in an appropriate sanitary condition.

  (e) Each freezer and cold storage compartment used to store and hold food capable of supporting growth of microorganisms shall be fitted with an indicating thermometer, temperature-measuring device, or temperature-recording device so installed as to show the temperature accurately within the compartment, and should be fitted with an automatic control for regulating temperature or with an automatic alarm system to indicate a significant temperature change in a manual operation.

  (f) Instruments and controls used for measuring, regulating, or recording temperatures, pH, acidity, water activity, or other conditions that control or prevent the growth of undesirable microorganisms in food shall be accurate and adequately maintained, and adequate in number for their designated uses.

  (g) Compressed air or other gases mechanically introduced into food or used to clean food-contact surfaces or equipment shall be treated in such a way that food is not contaminated with unlawful indirect food additives.

  110.40 设备及工器具

  a.生产加工企业的所有设备和工器具,其设计、采用的材料和制作工艺,必须便于适当的清洗和维护,这些设备和工器具的设计、结构和使用,必须防止食品中润滑剂、燃料、金属碎片、污水或其他污染物的掺杂。在安装和维修所有设备时必须考虑到,应便于设备及其邻近位置的清洗。接触食品的表面必须耐腐蚀。设备和工器具必须采用无毒的材料制成,在设计上应能耐受加工环境、食品本身以及清洁剂、消毒剂(如果可以使用)的侵蚀作用。必须维护好食品接触面,防止食品受到任何有害物,包括未按标准规定使用食品添加剂的污染。

  b.食品接触面的接缝必须平滑,而且维护良好,以尽量减少食品颗粒、异物及有机物的堆积,将微生物生长繁殖的机会降低到最低限度。

  c.食品加工、处理区域内不与食品接触的设备必须安装在合理的位置,以便于卫生清洁的维护。

  d.食品的存放、输送和加工系统,包括重量分析系统、气体流动系统、封闭系统及自动化系统等,其设计及结构必须能使其保持良好的卫生状态。

  e.凡用于存放食品并可抑制微生物生长繁殖的冷藏库及冷冻库,必须安装准确显示库内温度的测量显示装置或温度记录装置,并且还须安装调节温度的自动控制装置或人工操作控制温度的自动报警系统。

  f.用于测量、调节或记录控制或防止有害微生物在食品中生长繁殖的温度、pH值、酸度、水分活度或其他条件的仪表和控制装置,必须精确并维护良好,同时其计量范围必须与所指定的用途相匹配。

  g.用以注入食品,或用来清洗食品接触面或设备的压缩空气及其他气体,必须经过严格的处理,防止食品受到气体中有害物质的污染。

  更多关于美国FDA 21 CFR 第110部分的内容,请详见美国FDA 21 CFR 第110部分关于食品生产企业现行良好操作规范(GMP)法规汇总



 
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