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§110.20 食品生產加工企業的廠房與地面(Plant and grounds)

   2011-04-19 525
核心提示:  原文后附帶中文翻譯,由食品伙伴網食品論壇網友gaoketian提供,食品伙伴網在此表示感謝!  110.20 Plant and grounds.  

  原文后附帶中文翻譯,由食品伙伴網食品論壇網友gaoketian提供,食品伙伴網在此表示感謝!

     § 110.20   Plant and grounds.

  (a) Grounds. The grounds about a food plant under the control of the operator shall be kept in a condition that will protect against the contamination of food. The methods for adequate maintenance of grounds include, but are not limited to:

  (1) Properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place, or harborage for pests.

  (2) Maintaining roads, yards, and parking lots so that they do not constitute a source of contamination in areas where food is exposed.

  (3) Adequately draining areas that may contribute contamination to food by seepage, foot-borne filth, or providing a breeding place for pests.

  (4) Operating systems for waste treatment and disposal in an adequate manner so that they do not constitute a source of contamination in areas where food is exposed.

  If the plant grounds are bordered by grounds not under the operator's control and not maintained in the manner described in paragraph (a) (1) through (3) of this section, care shall be exercised in the plant by inspection, extermination, or other means to exclude pests, dirt, and filth that may be a source of food contamination.

  (b) Plant construction and design. Plant buildings and structures shall be suitable in size, construction, and design to facilitate maintenance and sanitary operations for food-manufacturing purposes. The plant and facilities shall:

  (1) Provide sufficient space for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food.

  (2) Permit the taking of proper precautions to reduce the potential for contamination of food, food-contact surfaces, or food-packaging materials with microorganisms, chemicals, filth, or other extraneous material. The potential for contamination may be reduced by adequate food safety controls and operating practices or effective design, including the separation of operations in which contamination is likely to occur, by one or more of the following means: location, time, partition, air flow, enclosed systems, or other effective means.

  (3) Permit the taking of proper precautions to protect food in outdoor bulk fermentation vessels by any effective means, including:

  (i) Using protective coverings.

  (ii) Controlling areas over and around the vessels to eliminate harborages for pests.

  (iii) Checking on a regular basis for pests and pest infestation.

  (iv) Skimming the fermentation vessels, as necessary.

  (4) Be constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair; that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating food or food-contact surfaces with clothing or personal contact.

  (5) Provide adequate lighting in hand-washing areas, dressing and locker rooms, and toilet rooms and in all areas where food is examined, processed, or stored and where equipment or utensils are cleaned; and provide safety-type light bulbs, fixtures, skylights, or other glass suspended over exposed food in any step of preparation or otherwise protect against food contamination in case of glass breakage.

  (6) Provide adequate ventilation or control equipment to minimize odors and vapors (including steam and noxious fumes) in areas where they may contaminate food; and locate and operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food, food-packaging materials, and food-contact surfaces.

  (7) Provide, where necessary, adequate screening or other protection against pests.

  110.20 廠房與地面

  a.地面:食品生產加工企業的地面必須保持良好的狀態,防止食品受污染。維護地面的方法包括,但不僅限于:

  (l) 合理放置設備,清除垃圾和廢料,鏟除廠房及其構造物附近可能成為害蟲習慣生活的孳生地或藏身處的雜草。

  (2) 搞好道路、廠區和停車場衛生,這些區域不得成為食品生產加工區域的污染源。

  (3) 凡因滲漏、鞋上的污染物或害蟲孽生地可能污染的食品區域,不得有積水。

  (4) 廢物處理系統不得成為食品裸露區域的污染源。如果毗連廠房的場地不在操作人員的管轄范圍之內,而且不是按照本節1.(1)至(3)段所說的方法管理時,那么必須在廠區內認真地檢查、滅蟲或采取其他措施以消除可能成為食品污染源的害蟲、廢料和污染物。

  b.廠房結構與設計:廠房建筑物的大小、結構與設計必須便于食品生產的維修和衛生操作。廠房及各種設施必須:

  (1)提供足夠的場地安裝設備,存放物料,以利于進行衛生操作和食品的安全生產。

  (2) 應采取適當的預防措施以減少食品、食品接觸面或食品包裝材料受到微生物、化學物、污物或其他外來物污染的潛在危害。可以通過適當的食品安全控制及操作規范或有效設計,包括將可能發生污染的不同生產加工分開(可采用以下任何一種或數種手段:地點、時間、隔墻、氣流、封閉的操作系統或其他有效方法),以減少食品受污染的潛在危害。

  (3) 采取適當的預防措施以保護露天發酵容器中的散裝食品,可以采用以下任何一種有效的保護手段:

  ⅰ使用保護性的覆蓋物;

  ⅱ有效控制食品容器周圍的區域,使害蟲無藏身之處;

  ⅲ定期檢查害蟲及其活動情況;

  ⅳ必要時除去發酵容器的表層漂浮物。

  (4) 結構合理。地板、走道、天花板應易于清掃,保持清潔及維護狀況良好;支架和管道上滴下的了冷凝水滴或冷凝物不得污染食品、食品接觸面或食品包裝材料;設備與墻面之間應留出通道和工作場地,且不能堵塞,其空間足以使員工進行操作,而且不使食品接觸面與員工的衣褲或人體相接觸而污染。

  (5) 洗手區、更衣室及衣帽間、衛生間,以及食品檢驗、加工或貯存,設備或工器具清洗的一切區域均應有充分的照明;在食品生產加工的任何環節,在裸露食品的上方須安裝安全燈泡、防護罩或者用其他方法防止玻璃碎裂時污染食品。

  (6) 凡是在有害的氣體可能污染的食品區域都應安裝足夠的通風或控制設備,以將各種氣體和蒸氣(包括水蒸氣和各種有害的煙氣)減少到最低限度;同時,將風扇及其他換氣設備安裝在適當的位置,以符合衛生要求,盡量減少污染食品、食品包裝材料及食品接觸面的潛在危害。

  (7) 在必要之處設置防止害蟲的網板或其他防護裝置。

  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
 



 
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