中国食品网

§110.20 食品生产加工企业的厂房与地面(Plant and grounds)

2011-04-19 中国食品网 中食网 643 0

  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!

   § 110.20 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 厂房与地面

  a.地面:食品生产加工企业的地面必须保持良好的状态,防止食品受污染。维护地面的方法包括,但不仅限于:

  (l) 合理放置设备,清除垃圾和废料,铲除厂房及其构造物附近可能成为害虫习惯生活的孳生地或藏身处的杂草。

  (2) 搞好道路、厂区和停车场卫生,这些区域不得成为食品生产加工区域的污染源。

  (3) 凡因渗漏、鞋上的污染物或害虫孽生地可能污染的食品区域,不得有积水。

  (4) 废物处理系统不得成为食品裸露区域的污染源。如果毗连厂房的场地不在操作人员的管辖范围之内,而且不是按照本节1.(1)至(3)段所说的方法管理时,那么必须在厂区内认真地检查、灭虫或采取其他措施以消除可能成为食品污染源的害虫、废料和污染物。

  b.厂房结构与设计:厂房建筑物的大小、结构与设计必须便于食品生产的维修和卫生操作。厂房及各种设施必须:

  (1)提供足够的场地安装设备,存放物料,以利于进行卫生操作和食品的安全生产。

  (2) 应采取适当的预防措施以减少食品、食品接触面或食品包装材料受到微生物、化学物、污物或其他外来物污染的潜在危害。可以通过适当的食品安全控制及操作规范或有效设计,包括将可能发生污染的不同生产加工分开(可采用以下任何一种或数种手段:地点、时间、隔墙、气流、封闭的操作系统或其他有效方法),以减少食品受污染的潜在危害。

  (3) 采取适当的预防措施以保护露天发酵容器中的散装食品,可以采用以下任何一种有效的保护手段:

  ⅰ使用保护性的覆盖物;

  ⅱ有效控制食品容器周围的区域,使害虫无藏身之处;

  ⅲ定期检查害虫及其活动情况;

  ⅳ必要时除去发酵容器的表层漂浮物。

  (4) 结构合理。地板、走道、天花板应易于清扫,保持清洁及维护状况良好;支架和管道上滴下的了冷凝水滴或冷凝物不得污染食品、食品接触面或食品包装材料;设备与墙面之间应留出通道和工作场地,且不能堵塞,其空间足以使员工进行操作,而且不使食品接触面与员工的衣裤或人体相接触而污染。

  (5) 洗手区、更衣室及衣帽间、卫生间,以及食品检验、加工或贮存,设备或工器具清洗的一切区域均应有充分的照明;在食品生产加工的任何环节,在裸露食品的上方须安装安全灯泡、防护罩或者用其他方法防止玻璃碎裂时污染食品。

  (6) 凡是在有害的气体可能污染的食品区域都应安装足够的通风或控制设备,以将各种气体和蒸气(包括水蒸气和各种有害的烟气)减少到最低限度;同时,将风扇及其他换气设备安装在适当的位置,以符合卫生要求,尽量减少污染食品、食品包装材料及食品接触面的潜在危害。

  (7) 在必要之处设置防止害虫的网板或其他防护装置。

  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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