设备清洁取样方法的研究

研究了设备清洁验证中如何确定合适取样点和取样方法。取样点应能够代表设备的＂最脏点＂,寻找有代表性的取样点时,首先考虑设备最难清洗部位。阐述了表面擦拭法和淋洗法2种取样方法,并结合药品生产企业在清洁验证工作中的实例,对同一关键设备建立不同清洁验证方案,通过对验证结果的对比分析,进一步阐述了表面擦拭法和淋洗法的合理应用。

Study on Cleaning Sampling Methods for Equipments

The choosing of sampling methods and sampling points were studied in equipment cleaning validation. The sampling points should stand for ＂the dirtiest point＂ of the equipment. The most difficult cleaning site should be firstly considered when looking for the representative sampling point. The two sampling methods were introduced that the surface swabbing method and elution method. According to the routine cleaning validation of company, different cleaning validation protocols were set up for one key equipment, based on the comparison and analysis of validation results, the reasonable application of surface swabbing method and elution method were elaborated.