Verification for Chemical Medicine Tablet Production Equipment Cleaning Method
10.6039/j.issn.1001-0408.2015.34.02
- VernacularTitle:化学药片剂生产设备清洁方法的验证
- Author:
Zhenping CHAI
;
Peng GAO
;
Yaling BAI
;
Lijuan HE
;
Wenxue REN
;
Zhanzhou HUANG
;
Jie LI
- Publication Type:Journal Article
- Keywords:
Chemical medicine;
Production equipment;
Cleaning method;
Validation
- From:
China Pharmacy
2015;(34):4756-4758
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To evaluate the rationality and validity of chemical medicine tablet production equipment cleaning pro-cedure. METHODS:Among several chemical medicines prepared by similar production technology as Metoprolol succinate sus-tained-release tablets,Captopril tablets,Isosorbide mononitrate tablet and Metformin hydrochloride tablet,Metoprolol succinate sus-tained-release tablets had strongest toxicity and were included in validation test. The production equipment was cleaned and disinfect-ed 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 wip-ing,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 pre-vent product contamination and cross contamination to ensure the quality,efficacy and safety of the next batch of products.
