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  • GMP洁净车间使用规范及要旨
    来源: 浏览:次 发布日期:2020-05-13
    1洁净区温度和湿度的要旨
    1 requirements for temperature and humidity in clean area
    原料药车间的温度和湿度都应有相应的规定,一般能够参考的值为:温度把握在17至25摄氏度,相对湿度把握在百分之28至百分之60。温度和湿度的记载应保证能够及时的观测数值的改动,一般记载跨距不该超越三钟点。若天气、设备等条件有较大的改动时,应及时调整记载的周期和始末。
    The temperature and humidity of API workshop shall have corresponding regulations. Generally, the values that can be referred to are: the temperature shall be controlled at 17-25 ℃, and the relative humidity shall be controlled at 28-60百分比. The temperature and humidity shall be recorded to ensure that the change of values can be observed in time. Generally, the recording distance shall not exceed three hours. If the weather, equipment and other conditions change greatly, the period and content recorded shall be adjusted in time.
    2洁净区紫外灯使用的要旨
    2 requirements for the use of ultraviolet lamp in clean area
    (1)当天作业完毕或暂时中止出产时,操作人员在脱离时应敞开紫外灯,持续照耀三十分钟。
    (1) When the operation is completed or the production is temporarily suspended on the same day, the operator shall turn on the ultraviolet light for 30 minutes when leaving.
    (2)紫外灯应按照照耀时的使用环境,酌情进行替换,并树立相应的记载。
    (2) The ultraviolet lamp shall be replaced as appropriate according to the use conditions when it is illuminated, and corresponding records shall be established.
    无菌室装潢
    3尘土粒子和沉降菌的监测
    3. Monitoring of dust particles and settling bacteria
    (1)尘土粒子应由有资质的人员进行监测,并树立相应记载。
    (1) Dust particles shall be monitored by qualified personnel and corresponding records shall be established.
    (2)沉降菌由出产单位负责监测并树立相应记载。
    (2) The producer shall be responsible for monitoring and recording the settling bacteria.
    4洁净区人员收支的要旨
    4 requirements for income and expenditure of personnel in clean area
    因为洁净区有洁净度的要旨,人员的数量和收支的频次会对其产生影响,易于 若无特殊环境,应保证洁净区的人员数量和频次较低,若有特殊环境,如外来人员的观赏、审计等,需经过出产负责人的批阅,并组织相应人员带领,按规定程序更衣下才能够进入洁净区。作业人员在进出洁净区时,应及时封闭各门,敞开和封闭门时应尽量轻,不能甩动门使其封闭。洁净区内的更衣室弛缓冲走廊内不该闲谈和长期的停留。
    Because the clean area has the requirement of cleanliness, the number of personnel and the frequency of income and expenditure will have an impact on it. Therefore, if there is no special situation, it should be ensured that the number and frequency of personnel in the clean area is low. If there is special situation, such as the viewing and auditing of external personnel, it needs to be approved by the person in charge of production, and the corresponding personnel should be organized to lead, and only after changing clothes according to the specified procedures can the clean area be entered 。 When entering and leaving the clean area, operators shall close the doors in time. When opening and closing the doors, they shall be as light as possible and shall not swing the doors to make them closed. The changing room in the clean area should not be chatted or stayed for a long time.
    4.1作业人员收支洁净区的主要流程
    Four point one Main process of clean area for revenue and expenditure of operators
    门厅→缓冲间→回身橱(换鞋)→一更衣室→二更衣室→洗手→缓冲走廊→接粉间→缓冲走廊→洗手→二更衣室→一更衣室→回身橱(换鞋)→缓冲间→门厅说明:一更衣室和二更衣室别离设有更衣橱,其间一更的更衣橱内用来放置本身穿戴的外衣和相应的物品;二更的更衣橱内用来放置岗位服,且不得有其他物品的出现。
    Hall → buffer room → return cabinet (changing shoes) → one changing room → two changing rooms → hand washing → buffer corridor → powder receiving room → buffer corridor → hand washing → two changing rooms → one changing room → return cabinet (changing shoes) → buffer room → hall Description: one changing room and two changing rooms are separated by a wardrobe, in which one changing cabinet is used to place the coat and corresponding articles that one wears; The second change locker is used to place post clothes, and no other items are allowed.
    4.2进入洁净区程序
    Four point two Procedure for entering clean area
    (1)换鞋。
    (1) Change shoes.
    替换作业鞋时应遵从以下次序和准则:①作业人员进入门厅上,在风幕下站立2-3分钟,充沛冲去衣物表面的积尘,然下进入门厅,填写相关记载。②作业人员坐在回身橱上,身体倾斜,将回身橱的内鞋柜翻开,并将其间的作业鞋甚至回身橱内侧的地上上,封闭内鞋橱。③脱去自穿的鞋子,并将其放入回身橱的外鞋橱并封闭外鞋橱,回身穿上作业鞋。④换鞋的进程中,作业鞋不能触摸回身橱的外面,自穿的鞋也不能够触摸回身橱的内面,不得赤脚触摸尽数地上。
    When replacing the work shoes, the following order and criteria shall be followed: ① before entering the hall, the operator shall stand under the wind curtain for 2-3 minutes, fully wash away the dust on the surface of the clothes, then enter the hall, and fill in the relevant records. ② The operator sits on the return cabinet and tilts his body, turns over the inner shoe cabinet of the return cabinet, and places the working shoes on the ground inside the return cabinet to close the inner shoe cabinet. ③ Take off the self wearing shoes, put them into the outer shoe cabinet of the return cabinet, close the outer shoe cabinet, and put on the work shoes. ④ In the process of changing shoes, the operation shoes shall not touch the outside of the return cabinet, nor the inner surface of the return cabinet, nor shall the shoes worn by oneself touch any ground barefoot.
    (2)替换作业服。
    (2) Replace work clothes.
    替换作业服时应遵从以下次序和准则:①换鞋完毕下,轻开门进入一更衣室,并及时关门。②脱下自穿的外套,放入更衣橱内,然下封闭更衣橱门。③进入二更衣室并随手关门。④进入二更衣室下,起首应带上作业帽,保证头发全部被作业帽包裹,然下穿洁净服,并且上衣应该束于下衣内。穿戴完毕下进行检查,无误下进入缓冲走廊,然下进入操作间。
    When replacing work clothes, the following order and criteria shall be followed: ① after changing shoes, open the door gently and enter a dressing room, and close the door in time. ② Take off your coat, put it in the locker, and then close the door of the locker. ③ Enter the second changing room and close the door. ④ After entering the second changing room, first put on the work cap to ensure that all hair is wrapped by the work cap, then wear clean clothes, and the top should be tied in the lower garment. Check after wearing, and enter the buffer corridor after no error, and then enter the operation room.
    4.3退出洁净区程序
    Four point three Exit clean area procedure
    (1)从操作岗位进入二更衣室下,先脱去帽子,再脱去上衣,更终脱去下衣,并将一切衣物放入更衣橱内。
    (1) After entering the second changing room from the operation post, take off the hat first, then the coat, and finally take off the clothes, and put all the clothes into the changing cabinet.
    (2)从二更衣室进入一更衣室,翻开更衣橱门,穿戴好自己的衣服。
    (2) Enter the first dressing room from the second dressing room, open the door of the dressing cabinet, and put on your own clothes.
    (3)人员坐在回身橱上,将回身橱的内门翻开,将作业鞋放入内橱并封闭橱门,从回身橱外侧拿出自己的鞋子,穿好下封闭外橱门。
    (3) Personnel sit on the return cabinet, open the inner door of the return cabinet, put the work shoes in the inner cabinet and close the cabinet door, take out their shoes from the outside of the return cabinet, and close the outer cabinet door after wearing them.
    空气净化工程
    4.4外来人员的规定
    Four point four Regulations on outsiders
    (1)外来人员进入洁净区之上,必须有出产负责人批准,并由相关人员带领进入,做好记载。
    (1) Before entering the clean area, the external personnel must be approved by the person in charge of production, and be led by relevant personnel to enter and make records.
    (2)外来人员需穿戴观赏服,而不得穿戴岗位作业服。
    (2) The external personnel shall wear ornamental clothes instead of post work clothes.
    (3)外来人员的更衣进程要遵从正常的程序。
    (3) The changing process of external personnel shall follow normal procedures.
    (4)外来人员观赏完毕下,车间人员要对相应区域进行排查,确保未对洁净区产生损坏。
    (4) After the visitors finished watching, the workshop staff should check the corresponding area to ensure that there is no damage to the clean area.
    5洁净区物料的收支
    5 revenue and expenditure of materials in clean area
    (1)包材进入洁净区的程序:包材→包材间→传递窗→接粉间。
    (1) Procedures for packaging materials entering the clean area: packaging materials → packaging materials room → transfer window → powder receiving room.
    (2)制品出洁净区的程序:制品→接粉间→制品暂存间→气闸室→缓冲走廊→制品待检间。
    (2) Procedures for products leaving the clean area: products → powder receiving room → temporary storage room of products → airlock room → buffer corridor → product waiting room.
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