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§ 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 卫生设施及控制
每个生产加工企业都必须配备足够的卫生设施及用具,它们包括,但不仅限于:
a.供水:供水必须满足预期的生产加工要求,而且必须来源充足。凡是接触食品或食品接触面的设备表面的水必须安全卫生并有良好的卫生质量。凡是需用水加工食品,用水清洗设备、工器具及食品包装材料、或需用水的员工卫生设施等均必须提供适当温度和所需压力的自来水。
b.输水设施:输水设施的设计及安装必须得当,并得到良好的维护,使其能:
(1) 将充足的水输送到厂区所需用水的场所。
(2) 将厂区的污水、废液顺畅地排除。
(3) 避免对食品、供水、设施或工器具构成污染,或造成不卫生的状况。
(4) 清洁地面时,在大量用水处或在地面正常加工时排水或其他液体排放处,提供足够的地面排水管道。
(5) 排放废水或污水的管道系统与食品或食品加工用水的管道系统之间不得有回流或交叉连接现象。
c.污水处理:污水必须通过适当的排污系统排放,或通过其他有效途径排除。
d.卫生间设施:每个生产加工企业必须为其员工提供足够的、方便进出的卫生间设施。通过下列措施可以达到这一要求:
(1) 保持设施的干净卫生。
(2) 在任何时候必须保持设施良好。
(3) 安装自动关闭门。
(4) 卫生间的门不能直接开向食品裸露区域避免使食品受不洁空气的污染,但是已采取其他措施防止这种污染的情况例外(如安装双重门或合理的气流系统)。
e.洗手设施:洗手设施安装的位置必须恰当、方便,同时必须提供适当温度的流动水。只有满足下列条件即可达到这一要求:
(1) 在生产加工区内的适当位置提供合理足够的手清洗和消毒设施,按照良好卫生规范要求员工洗手和/或消毒。
(2) 做好有效洗手和消毒手的准备工作。
(3) 提供干手用的卫生(纸)巾或合适的烘干装置。
(4) 洗手消毒设施,如供水阀(水龙头等)的设计及结构应为非手动式,防止清洁消毒过的手再次受到污染。
(5) 设立简明易懂的标语牌,提示负责加工未受保护的食品、食品包装材料及食品接触面的员工,在开始工作之前、每次离开工作岗位之后以及手可能被污染时,一定要洗手,并在适当的位置对手进行清洗消毒。这些标语牌可以贴在加工间及员工们可能接触上述食品、材料或表面的所有区域。
(6) 存放废料的容器结构及其维护须达到防止食品受污染的要求。
f.垃圾及废料:垃圾及废料必须适时运送、存放和清除,以减少气味,尽量不使其招引害虫或成为害虫的藏身处或孽生地,并避免食品、食品接触面、供水及地面受其污染。
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