实验室器具清洗机清洁工艺验证

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ANNEX 2
Example of validation of a cleaning procedure for volumetric glassware using a glasswarewashing machine (source: CY – Workshop for auditors October 2015)

1. The procedure can be used during the IQ-OQ of the new glassware washing machine and forPQ (e.g. every 6 months);
2. The laboratory chooses an available “difficult to clean” API;
3. From the volumetric flasks described in the testing method of the selected API, two ofthe lower and two of the maximum nominal volume flasks are selected (e.g. 2 x 5mland 2 x 100ml volumetric flasks);
4. A reference solution of the API is prepared as described in the testing method;
5. Each of the selected volumetric flasks is filled to about 10% of its nominal volume with thisreference solution, closed and shaken so the inner walls of the flasks will be covered by theliquid. They are emptied and allowed to dry;
6. The 4 flasks are then washed alone in the washing machine using the defined washinginstructions (Empty Load);
7. The same procedure is performed with the maximum number of volumetric flasks that canbe washed in the washing machine (Full Load);
8. All the flasks are filled with the solvent solution used for the preparation of the ReferenceStandard Solution and analysed with the HPLC testing method of the API used (the methodis validated and the validation parameters, e.g. LOD, LOQ etc. are used);
9. No traces of the API above the LOD of the method should be detected.

选自：MANAGEMENT OF VOLUMETRIC GLASSWARE

孟磊mlccxg

谢谢谢谢谢谢谢谢

小金库

好资料，拿走了