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首页> 外文期刊>Pharmaceutical development and technology >Effect of dirty-hold time on cleaning process of pharmaceutical equipment.
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Effect of dirty-hold time on cleaning process of pharmaceutical equipment.

机译:脏污时间对制药设备清洁过程的影响。

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The work was aimed at the evaluation of a cleanliness of pharmaceutical equipments after the end of the production and subsequent cleaning process. The influence of a dirty-hold time, a time interval between the end of the production period and the beginning of the cleaning process on its efficiency and the cleanliness of the equipment has been studied. The evaluation was performed for commercial tablet antihypertensive formulation with API losartan potassium. Sampling was carried out by a wet-swabbing method from the equipments and consequently obtained samples were analytically evaluated using HPLC. In the production of the concerned pharmaceutical, it has been found that the cleaning process is properly designed and validated. Despite the concentration of losartan in swabs from the equipment was in all cases within the limits of acceptance criteria, the effect of the dirty-hold time was proved. In the equipments with long hold-time period, the monitored substance was found in substantially higher concentrations.
机译:这项工作的目的是在生产结束和随后的清洁过程之后对制药设备的清洁度进行评估。研究了脏污时间,生产周期结束和清洁过程开始之间的时间间隔对其脏污效率和设备清洁度的影响。对使用API​​氯沙坦钾的商业片剂降压制剂进行了评估。用湿拭法从设备取样,然后用HPLC对得到的样品进行分析评价。在有关药物的生产中,已经发现清洗过程是经过适当设计和验证的。尽管在所有情况下设备中的棉签中氯沙坦的浓度均在可接受标准的范围内,但已证明了脏保持时间的影响。在保持时间较长的设备中,发现受监测物质的浓度要高得多。

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