BSA224S 天平的操作、维护和校准(精品).doc

SOP No.: AD-EQU-259-01 XX Company标准操作规程 Standard Operating Procedure 题 目：BSA224S 天平的操作、维护和校准Title:BSA224S BALANCE OPERATION, MAINTENANCE AND CALIBRATION 生效时间：下次审核时间至Effective Date:Next Review Due分发部门：药物分析部、质量保证部Area to be distributed:ARD, QA姓名：Print Name:职位： Title:签名：Signature:日期： Date:起草人：Initiator:审核人Reviewer：审核人：Reviewer:批准人：Approver: 请使用部门的当前版本 Please check the current version in your department before using. 1 of 5 SOP No.: AD-EQU-259-01 xx目的：Purpose:本操作规程是为ARD(Analytical Research & Development)分析实验室的所有BSA224S天平的使用，维护和校准提供标准化程序。

The purpose of this document is to provide the procedure for the operation, maintenance and calibration of all BSA224S balances in the ARD (analytical development)laboratory. 范围：Scope:ARD分析实验室内所有BSA224S天平的使用，维护和校准都应遵循此规程This procedure applies to the operation, maintenance and calibration of all BSA224S balances used in ARD laboratory.定义：Definitions:N/A职责：Responsibility:ARD研究员有责任遵守该规程并且保证能够符合SOP中的要求ARD研究员必须经过此SOP培训才能使用分析天平ARD scientists are responsible to comply with this procedure and ensure each requirement in this SOP is carried out. ARD scientists can not use the analytical balance till SOP training completed.规程内容：Procedural description:1日常使用Daily use特定的操作，维护和解除故障可以参照使用说明书。

维护和维修必须记录在仪器档案中Refer to instrument manuals for specific operating, maintenance and troubleshooting procedures. The record of maintenance and repair work performed should be stored in the balance equipment file.操作步骤如下The operating procedure is specified as below:1.1打开电源Switch on the power key.1.2检查气泡是否位于水平仪上圆圈的中央Check the air bubble at the centre of circle of the gradienter.1.3打印前清零，读数稳定后按打印键 Tare the data before print, press the print key after the reading is stable.1.4全部称量结束后，按下天平上的 CF键。

Press the CF key after completing the weighings. 2.天平外部校准Balance External Calibration 2.1清空天平，通过按cal 键，可进行天平的校准Clean the balance, and then press the cal key to calibrate the balance. 2.2放入200g砝码，当屏幕出现“200.0000g”后，说明校准完成Put on the reference weight （200g）. When “200.0000g” appears on the screen, means that the calibration is completed.2.3按CF 键，可以在任何时候中断天平校准程序Press the CF key to interrupt the calibration of balance, if necessary.2.4除特殊情况下 （如：清理称量盘等），一个星期进行一次校准即可Perform the calibration once every week, except for special case, e.g. clear the weighing pan.3日常校验 Daily Check3.1所有的天平，应该在使用当天第一次使用前通过校准。

All balances should be calibrated on the day before use.3.2采用通过法定机构校验的F1级标准砝码，校准天平Use F1 level reference weight, which are calibrated by authorities, to calibrate the balance.3.3用重量为100mg、10g、200g标准砝码日常校验天平同时选择5g的标准砝码考察天平的漂移趋势Daily check the balance with reference weights of 100mg, 10g and 200g. And at the same time choose 5g reference weight to check the drift trend of the balance.3.4可接受标准：Acceptance Criteria:日常校验称重每个标准砝码一次，漂移检验重复称重标准砝码三次，并符合以下标准：500mg±0.3mg， 10g±0.3mg, 200g±0.2mg 和 5g±0.3mgWeigh every selected reference weight once for daily check and triplicate for drift check. And the weighting results should meet the accept criteria as follows: 500mg±0.3mg, 10g±0.3mg, 200g±0.2mg and 5g±0.3mg. 3.5在天平仪器上标示称量范围。

Label the weight range on balnace insruments.4天平的维护：Balances Maintenance:4.1常规维护：Routine Maintenance:每次使用前检查称量盘是否干净当在称量盘上发现到任何杂质，称量盘需要清洁如果在操作天平时发现任何异常情况并且不容易纠正时，应及时通知仪器负责人，清晰表明其禁用状态通知并要求有资格的职员对天平进行维修记录仪器的异常状态，异常是如何及何时发现的，补救措施，记录人的姓名和日期Prior to using the balance, check the weighing pan for cleanness. If any foreign matter is observed on the weighing pan, the pan should be cleaned. If any irregularities are noted in the operation of the balance and cannot be easily corrected, inform the instrument manager to clearly indicate the un-suitable-to-use status of the balance. Notify the qualified person to fix the balance in time. Record the irregularity, how and when the irregularity was discovered, the remedial action taken, as well as the initials of the person making the entry and the date.4.2预防性维护Preventive Maintenance每一年完成一次MU(Measurement Uncertainty)验证来定期确定天平的最小样品称样量，用重量为500mg和5g标准砝码校准MU测试，每个水平的标准砝码重复称量，且不能小于10次的。

Perform MU(Measurement Uncertainty) qualification every 1 year to determine the minimum weight could be performed on the balance, do MU qualification with reference weight of 500mg and 5g. At least ten replicate measurement for each level. 如果3倍测试结果的标准偏差（n≥10）除以标准砝码的重量不超。