扫描二维码 分享好友和朋友圈
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！
§ 110.35 Sanitary operations.
（a） General maintenance. Buildings, fixtures, and other physical facilities of the plant shall be maintained in a sanitary condition and shall be kept in repair sufficient to prevent food from becoming adulterated within the meaning of the act. Cleaning and sanitizing of utensils and equipment shall be conducted in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials.
（b） Substances used in cleaning and sanitizing; storage of toxic materials. （1） Cleaning compounds and sanitizing agents used in cleaning and sanitizing procedures shall be free from undesirable microorganisms and shall be safe and adequate under the conditions of use. Compliance with this requirement may be verified by any effective means including purchase of these substances under a supplier's guarantee or certification, or examination of these substances for contamination. Only the following toxic materials may be used or stored in a plant where food is processed or exposed:
（i） Those required to maintain clean and sanitary conditions;
（ii） Those necessary for use in laboratory testing procedures;
（iii） Those necessary for plant and equipment maintenance and operation; and
（iv） Those necessary for use in the plant's operations.
（2） Toxic cleaning compounds, sanitizing agents, and pesticide chemicals shall be identified, held, and stored in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. All relevant regulations promulgated by other Federal, State, and local government agencies for the application, use, or holding of these products should be followed.
（c） Pest control. No pests shall be allowed in any area of a food plant. Guard or guide dogs may be allowed in some areas of a plant if the presence of the dogs is unlikely to result in contamination of food, food-contact surfaces, or food-packaging materials. Effective measures shall be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. The use of insecticides or rodenticides is permitted only under precautions and restrictions that will protect against the contamination of food, food-contact surfaces, and food-packaging materials.
（d） Sanitation of food-contact surfaces. All food-contact surfaces, including utensils and food-contact surfaces of equipment, shall be cleaned as frequently as necessary to protect against contamination of food.
（1） Food-contact surfaces used for manufacturing or holding low-moisture food shall be in a dry, sanitary condition at the time of use. When the surfaces are wet-cleaned, they shall, when necessary, be sanitized and thoroughly dried before subsequent use.
（2） In wet processing, when cleaning is necessary to protect against the introduction of microorganisms into food, all food-contact surfaces shall be cleaned and sanitized before use and after any interruption during which the food-contact surfaces may have become contaminated. Where equipment and utensils are used in a continuous production operation, the utensils and food-contact surfaces of the equipment shall be cleaned and sanitized as necessary.
（3） Non-food-contact surfaces of equipment used in the operation of food plants should be cleaned as frequently as necessary to protect against contamination of food.
（4） Single-service articles （such as utensils intended for one-time use, paper cups, and paper towels） should be stored in appropriate containers and shall be handled, dispensed, used, and disposed of in a manner that protects against contamination of food or food-contact surfaces.
（5） Sanitizing agents shall be adequate and safe under conditions of use. Any facility, procedure, or machine is acceptable for cleaning and sanitizing equipment and utensils if it is established that the facility, procedure, or machine will routinely render equipment and utensils clean and provide adequate cleaning and sanitizing treatment.
（e） Storage and handling of cleaned portable equipment and utensils. Cleaned and sanitized portable equipment with food-contact surfaces and utensils should be stored in a location and manner that protects food-contact surfaces from contamination.
[51 FR 24475, June 19, 1986, as amended at 54 FR 24892, June 12, 1989]
110.35 卫生操作
a.一般保养：生产加工企业的建筑物、固定装置及其他有形设施必须在卫生的条件下进行维护和保养，防止食品成为条例所指的劣质食品。对工器具和设备进行清洗和消毒时必须认真操作，防止食品、食品接触面或食品包装材料受到污染。
b.用于清洗和消毒的物质、有毒化合物的存放：
（1） 用于清洗和消毒的清洗剂和消毒剂不得被有害微生物污染，而且必须在使用时绝对安全和有效。可以通过一些有效的手段来证实是否符合上述要求，比如根据供货商的担保或证明书或检验这些物质是否存在污染而确定能否购买这些物质。在加工食品或食品裸露的厂房内，只许使用或存放下列有毒物质：
ⅰ 为保持清洁和卫生状况所需的物质；
ⅱ 化验室检验用的而必须物质；
ⅲ 厂房和设备保养及运转所需的物质；
ⅳ 生产加工企业生产加工必须使用的物质。
（2） 有毒的清洁剂、消毒剂及杀虫剂必须易于识别、妥善存放，防止食品、食品接触面或食品包装材料受其污染。必须遵守联邦、州及地方政府机构制定的关于使用或存放这些产品的一切有关法规。
c.虫害控制：食品生产加工企业的任何区域均不得存在害虫。看门或带路的狗可以养在生产加工企业的某些区域，但它们在这些区域不得构成对食品、食品接触面或食品包装材料的污染。必须采取有效措施在加工区域内除虫，以避免食品在上述区域内受害虫污染。只有认真谨慎且有限制地使用杀虫剂和灭鼠剂才能避免其对食品、食品接触面及食品包装材料的污染。
d.食品接触面的卫生：所有食品接触面，包括工器具及设备的食品接触面，均必须尽可能经常地进行清洗，以免食品受到污染。
（1） 用于加工或存放低水分含量食品的接触面，必须处于干燥和卫生状态。这些食品表面用水清洗后，必须在下次使用前进行消毒并彻底干燥。
（2）在湿加工过程中，为了防止微生物进入食品而必须进行清洗时，所有食品接触面在使用前或可能被污染时都必须清洗和消毒。如使用该设备和工器具进行连续生产加工时，必须对这些工器具以及设备的食品接触面进行清洗和消毒。
（3） 食品生产设备的非食品接触面也应当尽量经常进行清洗消毒，以防止食品受到污染。
（4） 一次性用品（如一次性用具、纸杯、纸巾）均应存放在适当的容器里，并且必须认真处理、分发、使用和弃置，以防止污染食品或食品接触面。
（5） 使用消毒剂时必须适量而且安全。如果已经证实某种装置、方法或机械能经常性地使生产设备和工器具保持清洁，并能充分地进行清洗和消毒，那么就可采用这种装置、方法或机械清洗和消毒生产设备用具。
c.已经清洗干净、可移动的设备及工器具的存放和处理。与食品接触面、已清洗干净并消毒的、可移动的设备以及工器具应以适当的方法存放在适当的场所，防止食品接触面受污染。
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
地区：
