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§ 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 設備及工器具
a.生產加工企業的所有設備和工器具,其設計、采用的材料和制作工藝,必須便于適當的清洗和維護,這些設備和工器具的設計、結構和使用,必須防止食品中潤滑劑、燃料、金屬碎片、污水或其他污染物的摻雜。在安裝和維修所有設備時必須考慮到,應便于設備及其鄰近位置的清洗。接觸食品的表面必須耐腐蝕。設備和工器具必須采用無毒的材料制成,在設計上應能耐受加工環境、食品本身以及清潔劑、消毒劑(如果可以使用)的侵蝕作用。必須維護好食品接觸面,防止食品受到任何有害物,包括未按標準規定使用食品添加劑的污染。
b.食品接觸面的接縫必須平滑,而且維護良好,以盡量減少食品顆粒、異物及有機物的堆積,將微生物生長繁殖的機會降低到最低限度。
c.食品加工、處理區域內不與食品接觸的設備必須安裝在合理的位置,以便于衛生清潔的維護。
d.食品的存放、輸送和加工系統,包括重量分析系統、氣體流動系統、封閉系統及自動化系統等,其設計及結構必須能使其保持良好的衛生狀態。
e.凡用于存放食品并可抑制微生物生長繁殖的冷藏庫及冷凍庫,必須安裝準確顯示庫內溫度的測量顯示裝置或溫度記錄裝置,并且還須安裝調節溫度的自動控制裝置或人工操作控制溫度的自動報警系統。
f.用于測量、調節或記錄控制或防止有害微生物在食品中生長繁殖的溫度、pH值、酸度、水分活度或其他條件的儀表和控制裝置,必須精確并維護良好,同時其計量范圍必須與所指定的用途相匹配。
g.用以注入食品,或用來清洗食品接觸面或設備的壓縮空氣及其他氣體,必須經過嚴格的處理,防止食品受到氣體中有害物質的污染。
更多關于美國FDA 21 CFR 第110部分的內容,請詳見美國FDA 21 CFR 第110部分關于食品生產企業現行良好操作規范(GMP)法規匯總