CGMP文件 分析天平的操作,校验和维护程序SOP.docVIP

标准操作程序 Standard Operating Procedure 文件编码Doc. No.: 颁发日期： Issue Date: 生效日期： Effective Date: 替代 ： Supersedes: 复审日期： Review Date: 页码：第1页共8页Page No.: 1 of 标题：分析天平的操作，校验和维护程序 TITLE: PROCEDURE FOR OPERATION, PERFORMANCE CHECK & MINTENANCE ANALYTICAL BALANCE Purpose: 描述了分析天平的操作与校验的程序。 To describe the procedure for operation and performance check of Analytical Balance. 2.0 范围 Scope: 适用于下表所列的分析天平的操作与校验： This procedure applies to operation and performance check of analytical balance of the following: 生产厂家 Make 仪器编号 I D NO 型号 Model 序列号 Sr no 量程 Capacity 最大称样量 Maximum Wt 最小称样量 Minimum Wt 210g ± 0.1 mg 41g ± 0.01 mg 200 g 10 mg 位置：检测中心天平室 Location : Quality Control Department (Balance Room) 3.0 定义 Definitions: 无 Nil 责任 Responsibility: 分析天平的操作与校验由检验员负责。 The responsibility of operation and to verify the performance check of Analytical balances lies with QC .Analyst. 5.0 程序 Procedure: 操作 Operation: 观察水平仪的气泡是否处于中心确认天平是否处于水平。如果没有，通过调节天平后方的地脚螺钉直至气泡处于中心位置。 Ensure that the balance is leveled by observing the air bubble is in the center of level indicator. If not adjust the leveling by turning foot screws at the rear side of the balance housing until the bubble is in the center of the level indictor. 打开天平电源开关。 Switch ‘ON’ the main switch of the balance. 按“ON/OFF”键。 Press “ON/OFF” key. 等30秒天平初始化后，天平显示‘0.00000’ g。否则按‘→ 0 ←’键。 Wait for about 30 seconds for the initialization of the balance. After initialization the balance displays ‘0.00000’ g . Otherwise, press ‘→ 0 ←’ key 当天平显示’0.00000’ 时，可以对天平开始操作。 When ’0.00000’ is displayed, the balance is ready for operation. 将称量纸或称量瓶置于称量盘中心，关上天平玻璃门。 Place the empty container / butter paper on the center of the pan and close the sliding glass doors. 等读数稳定。 Wait till the balance shows stable reading. 按‘→T ←’键清零，显示变为 ‘0.00000’ g 。称量纸或称量瓶的重量被去皮重了。 Tare the weight by pressing ‘→T ←’ key briefly. The display changes to ‘0.00000’ g. Now the weight of the container