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§ 110.35 Sanitary operations.
?。╝） 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.
?。╞） 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:
?。╥） Those required to maintain clean and sanitary conditions;
（ii） Those necessary for use in laboratory testing procedures;
?。╥ii） Those necessary for plant and equipment maintenance and operation; and
?。╥v） 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.
?。╟） 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.
?。╠） 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.
?。?） 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.
?。?） 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.
?。?） 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.
?。?） 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.
?。╡） 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 衛(wèi)生操作
a.一般保養(yǎng)：生產(chǎn)加工企業(yè)的建筑物、固定裝置及其他有形設(shè)施必須在衛(wèi)生的條件下進(jìn)行維護(hù)和保養(yǎng)，防止食品成為條例所指的劣質(zhì)食品。對(duì)工器具和設(shè)備進(jìn)行清洗和消毒時(shí)必須認(rèn)真操作，防止食品、食品接觸面或食品包裝材料受到污染。
b.用于清洗和消毒的物質(zhì)、有毒化合物的存放：
?。?） 用于清洗和消毒的清洗劑和消毒劑不得被有害微生物污染，而且必須在使用時(shí)絕對(duì)安全和有效?？梢酝ㄟ^(guò)一些有效的手段來(lái)證實(shí)是否符合上述要求，比如根據(jù)供貨商的擔(dān)?；蜃C明書(shū)或檢驗(yàn)這些物質(zhì)是否存在污染而確定能否購(gòu)買(mǎi)這些物質(zhì)。在加工食品或食品裸露的廠房?jī)?nèi)，只許使用或存放下列有毒物質(zhì)：
?、?為保持清潔和衛(wèi)生狀況所需的物質(zhì)；
?、?化驗(yàn)室檢驗(yàn)用的而必須物質(zhì)；
?、?廠房和設(shè)備保養(yǎng)及運(yùn)轉(zhuǎn)所需的物質(zhì)；
?、?生產(chǎn)加工企業(yè)生產(chǎn)加工必須使用的物質(zhì)。
?。?） 有毒的清潔劑、消毒劑及殺蟲(chóng)劑必須易于識(shí)別、妥善存放，防止食品、食品接觸面或食品包裝材料受其污染。必須遵守聯(lián)邦、州及地方政府機(jī)構(gòu)制定的關(guān)于使用或存放這些產(chǎn)品的一切有關(guān)法規(guī)。
c.蟲(chóng)害控制：食品生產(chǎn)加工企業(yè)的任何區(qū)域均不得存在害蟲(chóng)?？撮T(mén)或帶路的狗可以養(yǎng)在生產(chǎn)加工企業(yè)的某些區(qū)域，但它們?cè)谶@些區(qū)域不得構(gòu)成對(duì)食品、食品接觸面或食品包裝材料的污染。必須采取有效措施在加工區(qū)域內(nèi)除蟲(chóng)，以避免食品在上述區(qū)域內(nèi)受害蟲(chóng)污染。只有認(rèn)真謹(jǐn)慎且有限制地使用殺蟲(chóng)劑和滅鼠劑才能避免其對(duì)食品、食品接觸面及食品包裝材料的污染。
d.食品接觸面的衛(wèi)生：所有食品接觸面，包括工器具及設(shè)備的食品接觸面，均必須盡可能經(jīng)常地進(jìn)行清洗，以免食品受到污染。
?。?） 用于加工或存放低水分含量食品的接觸面，必須處于干燥和衛(wèi)生狀態(tài)。這些食品表面用水清洗后，必須在下次使用前進(jìn)行消毒并徹底干燥。
?。?）在濕加工過(guò)程中，為了防止微生物進(jìn)入食品而必須進(jìn)行清洗時(shí)，所有食品接觸面在使用前或可能被污染時(shí)都必須清洗和消毒。如使用該設(shè)備和工器具進(jìn)行連續(xù)生產(chǎn)加工時(shí)，必須對(duì)這些工器具以及設(shè)備的食品接觸面進(jìn)行清洗和消毒。
?。?） 食品生產(chǎn)設(shè)備的非食品接觸面也應(yīng)當(dāng)盡量經(jīng)常進(jìn)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、紙杯、紙巾）均應(yīng)存放在適當(dāng)?shù)娜萜骼?，并且必須認(rèn)真處理、分發(fā)、使用和棄置，以防止污染食品或食品接觸面。
?。?） 使用消毒劑時(shí)必須適量而且安全。如果已經(jīng)證實(shí)某種裝置、方法或機(jī)械能經(jīng)常性地使生產(chǎn)設(shè)備和工器具保持清潔，并能充分地進(jìn)行清洗和消毒，那么就可采用這種裝置、方法或機(jī)械清洗和消毒生產(chǎn)設(shè)備用具。
c.已經(jīng)清洗干凈、可移動(dòng)的設(shè)備及工器具的存放和處理。與食品接觸面、已清洗干凈并消毒的、可移動(dòng)的設(shè)備以及工器具應(yīng)以適當(dāng)?shù)姆椒ù娣旁谶m當(dāng)?shù)膱?chǎng)所，防止食品接觸面受污染。
更多關(guān)于美國(guó)FDA 21 CFR 第110部分的內(nèi)容，請(qǐng)?jiān)斠?jiàn)美國(guó)FDA 21 CFR 第110部分關(guān)于食品生產(chǎn)企業(yè)現(xiàn)行良好操作規(guī)范（GMP）法規(guī)匯總
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編輯：foodfagui