FDA对洁净区一更必须用温水洗手的条文在哪里？

study888888

FDA对洁净区一更必须用温水洗手的条文在哪里？

我是来学东西的

没听说过，为啥是温水

药白2021

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION
PART 110 -- CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD

Subpart B - Buildings and Facilities

Sec. 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 unprotected 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.

门门

以人为本，太凉了不舒服

yc20160802

FDA不会有这等具体规定。

门门

yc20160802 发表于 2023-8-31 20:10
FDA不会有这等具体规定。

板凳层 的长篇来自哪里？

栗子7

哈哈哈，作为员工配了温水，更爱洗手

准圣级药老

没听说啊，看楼层回复的那一大溜的英文是什么意思啊？

lcl1105

更衣室手消毒后能不能烘干的规定有吗？

来自安卓APP客户端

优秀的小嘉

药白2021 发表于 2023-8-31 19:41
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SE ...

21 食品和药品
1章节 食品和药品管理
人类健康服务 部分
110 cGMP：食品生产、包装、保存
B 建筑设施
110.37 卫生设施和控制 每个厂房均应配置适宜的卫生设施和住宿，包括但不限于：
（e）洗手设施。洗手设施应当充足而方便，使用适宜温度的流水。

xqliu

标题21——食品和药物第一章——卫生和公众服务部食品和药物管理局
第二章——供人类食用的食品
第110部分——人类食品生产、包装或保存的现行良好生产规范
第二部分——建筑和设施第110.37节卫生设施和控制。
每个工厂应配备足够的卫生设施和住宿，包括但不限于:
(a)供水。供水须足以应付拟进行的操作，并须来自适当的水源。任何接触食品或食品接触面的水必须是安全的，并具有足够的卫生质量。在食品加工、设备、器具和食品包装材料清洗或员工卫生设施所需的所有区域，应提供适当温度和必要压力的自来水。
(b)管道。管道应具有适当的尺寸和设计，并适当安装和维护，以便:
   (1)将足够数量的水输送到整个工厂所需的位置。
   (2)妥善输送工厂污水和一次性液体废弃物。
   (3)避免对食品、水源、设备或器具构成污染源，或造成不卫生的状况。
   (4)在所有须进行淹水式清洁的地板，或在正常操作时会在地板上排放水或其他液体废物的地方，提供足够的地板排水系统。
   (5)规定排放废水或污水的管道系统与为食品或食品制造输送水的管道系统之间不存在回流或交叉连接。
(c)污水处理。污水处置须进入适当的污水收集系统，或以其他适当方法处置。
(d)厕所设施。每个工厂应为其员工提供足够的、方便使用的厕所设施。
    符合这一要求可通过以下方式完成:
    (1)保持设施处于卫生状态。
    (2)始终保持设施完好。
    (3)提供自闭门。
    (4)提供不能打开的门，进入食品暴露于空气污染的区域，除非采取了防止这种污染的替代方法(如双门或正气流系统)。
(e)洗手设施。洗手设施应当充足、方便，并配备适宜温度的自来水。
    符合这一要求可以通过提供:
    (1)在工厂的每个地方，在适当的情况下，洗手和洗手消毒设施，良好的卫生规范要求员工洗手和/或消毒他们的手。
    (2)有效的洗手和消毒制剂。
    (3)卫生巾服务或合适的干燥设备。
    (4)设备或固定装置，如水控制阀，其设计和制造可防止清洁、消毒的手再污染。
    (5)易于理解的标志，指示处理未受保护的食品、未受保护的食品包装材料和食品接触面的员工在开始工作前、每次缺勤后以及他们的手可能被弄脏或污染时洗手，并在适当的情况下消毒。这些标志可以张贴在加工车间和员工可能处理此类食品、材料或表面的所有其他区域。
    (6)拒绝以防止食品污染的方式建造和维护的容器。
(f)垃圾及内脏的处理。垃圾和任何内脏的运输、储存和处置应尽量减少气味的产生，尽量减少废物成为害虫的引诱剂、窝藏或滋生地的可能性，并防止污染食物、食物接触面、供水和地面。

机翻，仅供参考。

moonlight_s

可参考ICH Q7：（对原料药的GMP规定）
4.15 Adequate, clean washing and toilet facilities should be provided for personnel. These washing facilities should be equipped with hot and cold water as appropriate, soap or detergent, air driers or single service towels. The washing and toilet facilities should be separate from, but easily accessible to, manufacturing areas. Adequate facilities for showering and/or changing clothes should be provided, when appropriate.
（……这些洗手设施应配备冷热水、肥皂或洗洁剂、干手机或一次性手巾……）
理由呢，就是为了让员工舒服，减少逃避洗手。

制药人梅之焕

更衣室手消毒后能不能烘干的规定有吗？

cloudsky

三楼条款中只是说合适的水温，并没有规定一定是温水。

振振公子

太凉了，人就不愿意洗手！

零下

不要纠结温水洗手的条文在哪里，群里的大佬已经给出了答案，CFR211.110 ， ICH Q7中有相关描述。
第二，亲身经历，FDA开过不符合项，更衣室洗手的水，没有温水。这个够充分了吧，兄弟

一壶清茶涤凡尘

那就在自来水阀门接一个既热水控温水龙头

来自苹果APP客户端

蓝雨~

不一定是温水吧，适宜温度就行。以前是培训讲过这个案例，说冬天洗手都是用冷水，员工怕冷都不洗手了

longgrass

用温水是员工舒适性考虑，避免冷水而不洗手。

来自安卓APP客户端

wuyuanbi

21CFR110是老版的食品GMP,现合并入21CFR117，117.37有要求洗手设施....适当温度的流动水