分析天平SOP

发布时间:2018-07-01 18:53:10   来源:文档文库   
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分析天平的操作与校验(sop

 

1.0      目的  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:

 

 

位置:检测中心天平室

3.0  定义 :      

4.0   责任  : 分析天平的操作与校验由检验员负责。

 5.0  程序  Procedure:   

5.1  操作  Operation:

5.1.1       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。

5.1.2      打开天平电源开关。

5.1.3        “ON/OFF”键。

5.1.4      30秒天平初始化后,天平显示‘0.00000’ g。否则按‘→ 0 ←’键。

5.1.5      当天平显示’0.00000’ 时,可以对天平开始操作。

5.1.6      将称量纸或称量瓶置于称量盘中心,关上天平玻璃门。

5.1.7        等读数稳定。

5.1.8        ‘→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。

5.1.9         加入称量样品达到规定量。 

5.1.10    等读数稳定。记录数据为总重量g

5.1.11    小心将样品移入量瓶后,将称量纸或称量瓶小心放置在称量盘中。

5.1.12    关上天平玻璃门等读数稳定,记录数据为皮重g

5.1.13    称量mg样品,按天平右边的 ‘F’键。显示变为‘ ‘0.00’ mg,接着按照5.1.6步骤进行称量。

5.2    提示   :

5.2.1       天平必须避免振动、风吹、高温、高湿。                                                                                                                             

5.2.2        AG245天平称量范围不得超过200g

5.2.3         读数稳定后再确认数据。

5.2.4        称量之前确保称量盘是干净的。用软毛刷清洁称量盘。

5.3       校验    

5.3.1分析天平的日校验

5.3.1.1  去除称量盘负载,清洁称量盘及其周围。

5.3.1.2  持续按右上角的“Cal”键至显示“Calibration Internal”

5.3.1.3  天平显示自校:开始显示+ 200.00000g 结束显示0.00000g        

5.3.1.4  10mg标准砝码置于称量盘中央,记录读数。

5.3.1.5  100mg标准砝码置于称量盘中央,等显示稳定记录读数。

5.3.1.6  200g砝码置于称量盘中央,将读数记录在天平校验记录里。

5.3.1.7  将校验细节记录在如附录I所示分析天平校验记录里。

5.3.2 月校验(多个标准砝码

准确度Accuracy:

5.3.2.1    用标准砝码校验天平。       

5.3.2.2  200 mg, 500 mg, 1g, 2 g, 5 g, 10 g, 20 g, 50 g, 100 g, 200 g标准砝码置于称量盘中央,记录读数。并奖结果记录在附录II所示的表格里。

5.3.3      标准限度Acceptance Criteria:

 

                      

5.3.4      重复性实验 Measurement of Repeatability:

5.3.4.1   确保标准砝码使用前已校验合格。                                                                    

5.3.4.2   确保天平做重复性实验前已校验合格。    

5.3.4.3  100mg标准砝码置于分析天平称量盘中央。                                               

5.3.4.4  记录读数。用同一标准砝码重复称10次,计算标准偏差值。              

5.3.4.5  1 g100g标准砝码重复5.3.4.35.3.4.4的步骤,计算标准偏差值。                                                                                                    

 5.3.4.6    将重复性数据记录在附录III所示的表格里。

5.3.4.7  如果重复性实验中出现任何偏差,必须对偏差进行调查,而且必须进行内部或代理商的校正。

5.3.4.8  校正后,天平必须进行机能检查和重复性实验。                    

                                 5.3.5     置信度   Uncertainty, precision (repeatability):

5.3.5.1 100 mg1 g and 100 gm的重复性数据计算不可信度

 

                               3  x  标准偏差

                     计算公式:  -------------------------------------------

                                             标准砝码重  

                          3  x  Standard Deviation

                     Calculation:  -------------------------------------------

                                           Standard Weight

 

           5.3.5.2      限度范围:≤0.001

 Acceptance Criteria: Should not be more than 0.001.       

              5.4  校验周期   Frequency for Calibration:

 5.4.1  用指定标准砝码进行每日校验。

Daily performance check to be done by using specified standard weights.

 5.4.2     多标准砝码校验周期:一个月+ 2 天。

Performance check with multiple standard weights shall be carried out once in a month  + 2 days.

5.4.3     重复性实验周期:一个月+ 2 天。

 Repeatability shall be done once in a month + 2 days.

5.5     维护计划  Maintenance Program :

5.5.1 当天平观察到需要维修/未通过校验时,应贴上维修标签(附件V),同时向QC经理报告。

Put “UNDER MAINTENANCE ” label (Annexure-V) on the instrument when it was observed breakdown / or out of calibration, intimate to Q.C. Manager.

5.5.2  QC经理通知仪器售后服务工程师,经修理后需校验仪器,检查是否正常工作并记录。(注意:本次校验为额外校验,应按照校验日程计划照常进行每月的校验)。

Q.C. Manager informs to the Instrument service engineer. After maintenance, calibrate the instrument to check its satisfactory functioning and record the readings. (Note: Calibrate the instrument as per the monthly calibration schedule, this calibration is an additional)

5.5.3 将仪器维修报告附在仪器维护历史文件中,按照附件VI的格式填写仪器故障的详细情况。

Retain service report copy attached in the Instrument Maintenance History File and enter the breakdown details in the enclosed format as Annexure-VI.

6.0    相关文件   Related Documents:

6.1 分析天平日校验记录(附录-I

6.2分析天平月校验记录(附录-II

6.3分析天平重复性实验记录(附录-III

6.4 校验状态标签(附录-IV

6.5 “维修标签(附录-V

6.6 仪器维修记录(附录-VI

6.7 仪器使用记录(附录-VII

7.0  修订记录  Revision Record:            

 

 

******文件终结符END OF DOCUMENT


附录I

 ANNEXURE-I

分析天平每日校验记录

DAILY PERFORMANCE CHECK RECORD OF ANALYTICAL BALANCE

参照文件编码Doc. Ref. No. :                                                                                                        表格号Form No. 

生效日期 Effective Date:

1页共1Page 1 of 1

仪器编号ID.No.                    序列号S/N:                生产厂家                                型号Model:                     MAX200g   MIN10mg

附录II  

ANNEXURE-II

分析天平每月校验记录

MONTHLY PERFORMANCE CHECK RECORD OF ANALYTICAL BALANCE

参照文件编码Doc. Ref. No.:                                                                                                             表格号Form No.:                             

生效日期Effective Date:

1页共1Page 1 of 1

仪器编号                                                                     序列号S/N:                                   生产厂家Make:    

型号Model:                                                                MAX200g                                    MIN10mg                                  准确度  Accuracy

 

下次校验日期Next Calibration due date : __________________________

 

 

附录III  

ANNEXURE-III

分析天平重复性(精密度) 每月实验记录

PRECISION (REPEATABILITY) OF ANALYTICAL BALANCE

参照文件编码Doc. Ref. No.:                                                                               表格号Form No.:  

生效日期Effective Date:    

1页共1Page 1 of  1           

校验日期 calibration on:                                               仪器编号ID.No.                                                  序列号S/N:                       

生产厂家                                                                        型号Model:                                                         MAX200g                                 

MIN10mg                                                                 精密度  (Balance Uncertainty)

根据准确度和精密度来确认上述天平性能是否合格。

Remarks: The performance of the above balance is satisfactory/Not Satisfactory in term of Accuracy and Precision are within the Limit

下次校验日期Next Calibration due date : __________________________

附件IV

 ANNEXURE IV

 

校准状态标签

CLIBRATION STATUS TAG

 

参照文件编码Doc. Ref. No.:                                                     标签号Label No.:  

生效日期Effective Date:

1页共1page1 of 1

 

附件V ANNEXURE V

 

附录-V

 ANNEXURE-V

分析天平维修标签

ANALYTICAL BANLANCE MAINTENANCE LABEL

参照文件编码Doc. Ref. No.:                                                    标签号Label No.:  

生效日期Effective Date:

1页共1page 1 of 1

 

 

附件VI 
ANNEXURE VI
仪器维修记录
MAINTENANCE RECORD

参照文件编码Doc. Ref. No.:                                                  表格号Form No.:  

生效日期Effective Date:

1页共1page 1 of 1

 

仪器名称Instrument Name                                                                        制造商Make:

型号Model:                                                                                                    仪器编码Instrument ID :                  

 

 

附件VII 

ANNEXURE VII

 

 分析天平的使用记录

ANALYTICAL BALANCE INSTRUMENT USAGE LOG BOOK

 

参照文件编码Doc. Ref. No. :                                      表格号Form No.:  

                                                             生效日期 Effective date:

                                                                                           1页共1Page 1 of 1

制造商MAKE:                                                                  型号MODEL NO :

仪器编号Instrument ID No:                                             序列号:SR NO:

最大量程Maximum Wt=                                                  最小量程Minimum Wt =

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