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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 requirements for temperature and humidity in clean area
    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 requirements for the use of ultraviolet lamp in clean area
    (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) The ultraviolet lamp shall be replaced as appropriate according to the use conditions when it is illuminated, and corresponding records shall be established.
    3. Monitoring of dust particles and settling bacteria
    (1) Dust particles shall be monitored by qualified personnel and corresponding records shall be established.
    (2) The producer shall be responsible for monitoring and recording the settling bacteria.
    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.
    Four point one Main process of clean area for revenue and expenditure of operators
    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.
    Four point two Procedure for entering clean area
    (1) Change shoes.
    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) Replace work clothes.
    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.
    Four point three Exit clean area procedure
    (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) Enter the first dressing room from the second dressing room, open the door of the dressing cabinet, and put on your own clothes.
    (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.
    Four point four Regulations on outsiders
    (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) The external personnel shall wear ornamental clothes instead of post work clothes.
    (3) The changing process of external personnel shall follow normal procedures.
    (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 revenue and expenditure of materials in clean area
    (1) Procedures for packaging materials entering the clean area: packaging materials → packaging materials room → transfer window → powder receiving room.
    (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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