化学药片剂生产设备清洁方法的验证  

Verification for Chemical Medicine Tablet Production Equipment Cleaning Method

作　　者：柴振平[1] 高鹏[1] 白亚灵[1] 何丽娟[1] 任文学[1] 黄占周[1] 李杰[1] 

机构地区：[1]石家庄以岭药业股份有限公司,石家庄050035

出　　处：《中国药房》2015年第34期4756-4758,共3页China Pharmacy

摘　　要：目的:评价化学药片剂生产设备清洁规程的合理性与有效性。方法:选择存在相似生产工艺的几种化学药——琥珀酸美托洛尔缓释片、卡托普利片、单硝酸异山梨酯片、盐酸二甲双胍片中毒性最强的琥珀酸美托洛尔缓释片为验证品种,对其生产设备按清洁规程进行清洁消毒,用棉签擦拭法对最难清洁点进行擦拭取样,验证其擦拭回收率、残留限度的检出限和定量限,评价其结果是否符合规定的限度。结果:经采用棉签擦拭法对最难清洁点进行擦拭取样、检测,结果各取样点均未见可见异物,产品残留量均<29.75μg/棉签、微生物限度均<50 CFU/棉签,各检测项目均符合对该药的规定标准。结论:该清洁方法能有效对生产设备进行清洁,防止产品污染和交叉污染,确保下批产品的质量、疗效和安全性。OBJECTIVE：To evaluate the rationality and validity of chemical medicine tablet production equipment cleaning procedure. METHODS：Among several chemical medicines prepared by similar production technology as Metoprolol succinate sustained-release tablets,Captopril tablets,Isosorbide mononitrate tablet and Metformin hydrochloride tablet,Metoprolol succinate sustained-release tablets had strongest toxicity and were included in validation test. The production equipment was cleaned and disinfected according to cleaning procedure. The point which was most difficult to clean could be wiped and sampled by using the cotton swab method. The detection limit and the limit of quantitation of the residue limits were verified as well as the recovery rate of wiping,in order to evaluate whether the results meet the requirements. RESULTS：The cotton swab method is adopted to wipe sample and detect the point which is most difficult to clean. The visible foreign body has not been found in each sampling point. The amount of residual drug is 〈29.75 μg/cotton bud,and microbial limits are〈 50 CFU/cotton bud,indicating test items are in line with the standard. CONCLUSIONS：The cleaning method can effectively clean the production equipment,and can effectively prevent product contamination and cross contamination to ensure the quality,efficacy and safety of the next batch of products.

关 键 词：化学药 生产设备 清洁方法 验证 

分 类 号：TQ46[化学工程—制药化工] R9[医药卫生—药学]