1.
目的 PURPOSE
此操作规程为ASU实验室内的Sotax 溶出仪的操作,维护和校准提供标准规程。
This SOP outlines the operation, maintenance and calibration of Sotax dissolution tester in ASU lab.
2.
范围 SCOPE   
此规程适用于ASU分析实验室内的Sotax 溶出仪的操作,维护和校准。
This procedure applies to the operation, maintenance and calibration of Sotax dissolution tester in ASU lab.
3.
定义 DEFINITIONS
3.1
溶出仪系统
Dissolution apparatus system
该系统是由溶出试验仪，恒温加热器， 泵， 系统监控器等部件组合而成。桨，篮 和溶出杯是溶出仪的主体部分。
The system is made up of Dissolution Test Station, Constant Temperature Heater. Pump, System Monitor etc. Paddle/basket and vessel is the main part of dissolution apparatus.
4.
职责 RESPONSIBILITIES
4.1.
岗位操作人员   
Operator
负责标准操作规程的执行。
Operate the instrument in compliance with this SOP.
4.2.
文件所属部门负责人
Head of the Department
负责审核/批准本部门SOP。
Review/approve SOP of this department.
5.
规程 PROCEDURE
5.1.
总则
General Requirements
5.1.1.
5.1.2.
5.1.3.
当在更换或修理部件影响分析结果或验证状态时，应对新的或修理后的部件进行安装确认和运行确认，以保证溶出仪处于良好的工作状态。
Whenever the parts of the dissolution tester that are replaced or repaired influence the analysis results or validation status , IQ/OQ for the new or repaired parts should be conducted to maintain the qualified state .
5.1.4.
溶出仪耗材，如杯，桨，篮，转轴损坏需更换时，需按照附件AD-EQU-433-01-A-01, 完成相应部件的确认方可放行仪器。确认结果以附件形式附在DM单中。
If the vessel, paddle, basket or belt need to be replaced, qualified the replaced part according to AD-EQU-433-01-A-01 before release the dissolution tester. The qualify results should be attached to the On Demand Maintenance Sheet.
5.2.
操作
Operation
5.2.1.
运行前检查
Pre-operational Preparation
5.2.1.1.
确认仪器已完成安装确认和运行确认，处于良好的运行状态中。
Confirm IQ and OQ of the equipment are completed, and it keeps in good condition.
5.2.1.2.
检查仪器各部分是否齐全，各部件之间连接是否完好，需要时审核仪器使用记录。
Check all the parts of the dissolution tester are in readiness and each part are well connected. Review the equipment logbook if necessary.
5.2.1.3.
检查仪器循环泵的管路及自动取样器的是否有污染物，发现应及时清理。
Check the water bath and heater circulator tubing, clean the contamination immediately if found.
5.2.2.
仪器使用
Instrument Usage
5.2.2.1.
连接电源，打开仪器。
Switch on the instrument.
5.2.2.2.    
按面板上水浴温度开关键开始加热水浴的水，按键设置水浴温度。
Put the button to heat the water bath, then put button to set the temperature.
5.2.2.3.    
从溶出测试单元的面板上选择主菜单，进入手动控制界面，开启泵冲洗循环管路，如需溶媒回补冲洗补液管路，检查所有通道是否顺畅。
Press the Menu key on the control panel of dissolution testing unit. Select the Manual function and then enter the manual mode. Turn on the pump. Wash the circulation tubes The media filling tubes should also be washed if media replacement will be selected. Make sure all tubes are unblocked.
5.2.2.4.
放入溶出杯，并加入规定体积的溶媒。安装搅拌桨或转轴（特性溶出装置需在试验开始前安装），装上白耦合柄。把取样针插入溶出仪取样口，装上过滤头。
Put dissolution vessels in the tank, and fill them with prescribed volume of dissolution media. Install the stirrers （IDR apparatus should be installed before starting test）Fix the white coupling handle on the stirrer. Insert sampling needle in the pipette opening and then fix filter to the needle.
5.2.2.5.
按菜单键-F2键进入方法编辑界面，设置转速，温度，取样时间并保存；按菜单键-F1键调入所需方法. 按F2"Start"键开始试验
Put and F2 to edit the method, set rotation speed, temperature and sampling time. Then put and F1 to select method. Put F2 to start the test.
5.2.2.6.
测试结束后，将仪器的取样针取下来，用纯水冲洗系统，清洗并擦干整个系统， 卸载所有的转轴，清洗溶出杯。水浴中的水一周更换一次，仪器长时间不使用，排干水浴中的水。
After finishing the test, Lower down the sampling needles and flush the whole the system with purified water. Clean and dry the whole system. Detach all the shafts, clean the vessel. Replace the water in the bath once a week; dry the water if dissolution instrument would not be used for long period.
5.2.2.7.
关掉溶出仪。
Switch off the power key of dissolution apparatus.
5.2.2.8.
6.
6.1.
预防性维护 Preventative maintenance
6.1.1.
预防性维护周期6个月。
Preventative Maintenance frequency is 6 months.
6.1.2.
检查主轴驱动皮带的磨损和张力松紧情况。
Inspect the spindle drive belt for wear, fraying and tension.
6.2.
日常维护 DAILY MAINTENANCE
维修 CORRECTIVE MAINTENANCE
6.2.1.
水浴里的水必须每隔10天换一次。
The water should be replaced within 10days usage .
6.2.2.
试验后管路要及时用蒸馏水冲洗。
The tube lines should be washed with purified water after usage.
6.2.3.
实验完成后应及时清理台面及溶出仪上的水渍。
Clean the bench and the surface of dissolution tester after test finished.
6.3.
维修 CORRECTIVE MAINTENANCE
6.3.1.
下列任何一种情况发生，可认为溶出仪发生故障：
The dissolution apparatus is considered to be malfunctioning if one of the following exists:
6.3.2.
转速不能达到设定值。
Failure to maintain the set value.
6.3.3.
一个或多个转轴运转不正常。
One or more spindles fail to turn properly.
6.3.4.
溶出仪水浴温度不能保持在370.5C。
Failure of the dissolution bath to maintain at 370.5C.
6.3.5.
如果溶出仪发生故障，则应立即通知QA，仪器管理员和组长。相关人员立即更新仪器的状态标识，清晰标明仪器的不可用状态。组长决定由谁来完成维修校准（制造商、研究员）。
If the dissolution apparatus is malfunctioning: notice QA, instrument manager and Group Leader at once. Related person should update the instrument status label at once, clearly showing that the instrument can not use. Group Leader decides who need to complete the maintenance and calibration (manufacturer or scientist).
6.4.
仅在下列所有操作都完成后才能更换回正常的仪器标签，重新放行仪器至正常使用：
When all the following works have been finished, the equipment ID card can be changed back to normal one and release the instrument for suitable use:
6.4.1.
所有维修已经完成。
All repairs are completed.
6.4.2.
对溶出仪进行必要的验证或确认，且结果合格。
Perform necessary qualification or check for the dissolution tester and the results are acceptable.
6.4.3.
在溶出仪的日常使用记录本上记录所有维护和维修工作。
Record all the maintenance and corrective work in the logbook.
6.5.
校准 Calibration
6.5.1.
校准频率
Frequency
每年至少对 Sotax 溶出度仪进行一次校准。
Calibration Sotax dissolution tester at least once a year.
6.5.2.
校准参数
Calibration Parameters
每年校准以下项目：
Perform the calibration annually：
转速，转轴的晃动度及垂直度，篮的晃动度，溶出杯的中心度及垂直度，桨/篮的高度，水浴及溶出杯溶媒温度，取样体积的准确性 及取样时间的的准确度。
Rotation speed, shaft wobble and verticality, basket wobble, vessel centering and verticality, paddle/basket height, temperature of bath and vessels, sampling volume accuracy and timer accuracy.
7.
附录 APPENDICES
AD-EQU-433-A
   
8.
参考文件 REFERENCE
   
仪器操作手册
Manual
9.
分发部门 DISTRIBUTION LISTS
质量保证部、分析服务部
QA, ASU
10.
centering修订历史 REVISION HISTORY
版本
Version
生效日期
Effective Date
修订描述
Description of Revision
AD-EQU-433-01
最初放行
Original Issue