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§110.37 食品生產加工企業的衛生設施及控制(Sanitary facilities and controls)

   2011-04-19 414
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!    110.37 Sanitary facilities

  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! 

      § 110.37   Sanitary facilities and controls.

  Each plant shall be equipped with adequate sanitary facilities and accommodations including, but not limited to:

  (a) Water supply. The water supply shall be sufficient for the operations intended and shall be derived from an adequate source. Any water that contacts food or food-contact surfaces shall be safe and of adequate sanitary quality. Running water at a suitable temperature, and under pressure as needed, shall be provided in all areas where required for the processing of food, for the cleaning of equipment, utensils, and food-packaging materials, or for employee sanitary facilities.

  (b) Plumbing. Plumbing shall be of adequate size and design and adequately installed and maintained to:

  (1) Carry sufficient quantities of water to required locations throughout the plant.

  (2) Properly convey sewage and liquid disposable waste from the plant.

  (3) Avoid constituting a source of contamination to food, water supplies, equipment, or utensils or creating an unsanitary condition.

  (4) Provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor.

  (5) Provide that there is not backflow from, or cross-connection between, piping systems that discharge waste water or sewage and piping systems that carry water for food or food manufacturing.

  (c) Sewage disposal. Sewage disposal shall be made into an adequate sewerage system or disposed of through other adequate means.

  (d) Toilet facilities. Each plant shall provide its employees with adequate, readily accessible toilet facilities. Compliance with this requirement may be accomplished by:

  (1) Maintaining the facilities in a sanitary condition.

  (2) Keeping the facilities in good repair at all times.

  (3) Providing self-closing doors.

  (4) Providing doors that do not open into areas where food is exposed to airborne contamination, except where alternate means have been taken to protect against such contamination (such as double doors or positive air-flow systems).

  (e) Hand-washing facilities. Hand-washing facilities shall be adequate and convenient and be furnished with running water at a suitable temperature. Compliance with this requirement may be accomplished by providing:

  (1) Hand-washing and, where appropriate, hand-sanitizing facilities at each location in the plant where good sanitary practices require employees to wash and/or sanitize their hands.

  (2) Effective hand-cleaning and sanitizing preparations.

  (3) Sanitary towel service or suitable drying devices.

  (4) Devices or fixtures, such as water control valves, so designed and constructed to protect against recontamination of clean, sanitized hands.

  (5) Readily understandable signs directing employees handling unproteced food, unprotected food-packaging materials, of food-contact surfaces to wash and, where appropriate, sanitize their hands before they start work, after each absence from post of duty, and when their hands may have become soiled or contaminated. These signs may be posted in the processing room(s) and in all other areas where employees may handle such food, materials, or surfaces.

  (6) Refuse receptacles that are constructed and maintained in a manner that protects against contamination of food.

  (f) Rubbish and offal disposal. Rubbish and any offal shall be so conveyed, stored, and disposed of as to minimize the development of odor, minimize the potential for the waste becoming an attractant and harborage or breeding place for pests, and protect against contamination of food, food-contact surfaces, water supplies, and ground surfaces.

  110.37 衛生設施及控制

  每個生產加工企業都必須配備足夠的衛生設施及用具,它們包括,但不僅限于:

  a.供水:供水必須滿足預期的生產加工要求,而且必須來源充足。凡是接觸食品或食品接觸面的設備表面的水必須安全衛生并有良好的衛生質量。凡是需用水加工食品,用水清洗設備、工器具及食品包裝材料、或需用水的員工衛生設施等均必須提供適當溫度和所需壓力的自來水。

  b.輸水設施:輸水設施的設計及安裝必須得當,并得到良好的維護,使其能:

  (1) 將充足的水輸送到廠區所需用水的場所。

  (2) 將廠區的污水、廢液順暢地排除。

  (3) 避免對食品、供水、設施或工器具構成污染,或造成不衛生的狀況。

  (4) 清潔地面時,在大量用水處或在地面正常加工時排水或其他液體排放處,提供足夠的地面排水管道。

  (5) 排放廢水或污水的管道系統與食品或食品加工用水的管道系統之間不得有回流或交叉連接現象。

  c.污水處理:污水必須通過適當的排污系統排放,或通過其他有效途徑排除。

  d.衛生間設施:每個生產加工企業必須為其員工提供足夠的、方便進出的衛生間設施。通過下列措施可以達到這一要求:

  (1) 保持設施的干凈衛生。

  (2) 在任何時候必須保持設施良好。

  (3) 安裝自動關閉門。

  (4) 衛生間的門不能直接開向食品裸露區域避免使食品受不潔空氣的污染,但是已采取其他措施防止這種污染的情況例外(如安裝雙重門或合理的氣流系統)。

  e.洗手設施:洗手設施安裝的位置必須恰當、方便,同時必須提供適當溫度的流動水。只有滿足下列條件即可達到這一要求:

  (1) 在生產加工區內的適當位置提供合理足夠的手清洗和消毒設施,按照良好衛生規范要求員工洗手和/或消毒。

  (2) 做好有效洗手和消毒手的準備工作。

  (3) 提供干手用的衛生(紙)巾或合適的烘干裝置。

  (4) 洗手消毒設施,如供水閥(水龍頭等)的設計及結構應為非手動式,防止清潔消毒過的手再次受到污染。

  (5) 設立簡明易懂的標語牌,提示負責加工未受保護的食品、食品包裝材料及食品接觸面的員工,在開始工作之前、每次離開工作崗位之后以及手可能被污染時,一定要洗手,并在適當的位置對手進行清洗消毒。這些標語牌可以貼在加工間及員工們可能接觸上述食品、材料或表面的所有區域。

  (6) 存放廢料的容器結構及其維護須達到防止食品受污染的要求。

  f.垃圾及廢料:垃圾及廢料必須適時運送、存放和清除,以減少氣味,盡量不使其招引害蟲或成為害蟲的藏身處或孽生地,并避免食品、食品接觸面、供水及地面受其污染。

  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



 
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