Validation of method for microbial limit test of fast vertical liquid hand disinfectant gel

TAN Qiaoting; YAN Jia; ZHOU Xin; SONG Hongtao

doi:10.3969/j.issn.1006-0111.2014.05.014

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Objective To establish a method for microbial limit test of fast vertical liquid hand disinfectant gel. Methods The membrane filtration method, in accordance with the Chinese Pharmacopoeia 2010 Edition (part two) relevant requirements of microbial limit test method for validation of microbial limit test for fast vertical liquid hand disinfectant gel. Bacillus subtilis, Staphylococcus aureus, Escherichia coli, Candida a lbicans, Aspergillus niger were taken as test bacteria, Pseudomonas aeruginosa and Staphylococcus aureus were taken as control bacteria. Verification test was carried out in parallel test for 3 independent, recoveries and every trail rate were calculated. Results In bacteria, molds and yeasts count method validation test, recovery test strain rate, the control bacteria test results met the requirements. Conclusion The membrane filtration method was feasible and effective, which could be used for microbial limit test of fast vertical liquid hand disinfectant gel.

Validation of method for microbial limit test of fast vertical liquid hand disinfectant gel

Department of Pharmacy, Fuzhou General Hospital of Nanjing Military Region, Fuzhou 350025, China

Received Date: 2013-06-06

Rev Recd Date: 2013-10-29

Key words:

fast vertical liquid hand disinfectant gel /
microbial limit test /
method validation /
membrane filtration method

Abstract: Objective To establish a method for microbial limit test of fast vertical liquid hand disinfectant gel. Methods The membrane filtration method, in accordance with the Chinese Pharmacopoeia 2010 Edition (part two) relevant requirements of microbial limit test method for validation of microbial limit test for fast vertical liquid hand disinfectant gel. Bacillus subtilis, Staphylococcus aureus, Escherichia coli, Candida a lbicans, Aspergillus niger were taken as test bacteria, Pseudomonas aeruginosa and Staphylococcus aureus were taken as control bacteria. Verification test was carried out in parallel test for 3 independent, recoveries and every trail rate were calculated. Results In bacteria, molds and yeasts count method validation test, recovery test strain rate, the control bacteria test results met the requirements. Conclusion The membrane filtration method was feasible and effective, which could be used for microbial limit test of fast vertical liquid hand disinfectant gel.

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Reference (8)

[1]	国家药典委员会. 中华人民共和国药典2010年版二部[S].北京:中国医药科技出版社,2010:附录Ⅺ J108.
[2]	江燕,张春瑛,钱文忠. 红花油凝胶微生物限度检查方法的验证[J].中国药师,2010,13(4):591-592.
[3]	李近磊,王嘉怡,迟丹怡,等. 复方克林霉素凝胶微生物限度检查法的方法验证研究[J].中国药房,2010,21(25):2380-2382.
[4]	杨淑先,赵新霞,牛坡. 林可霉素利多卡因凝胶微生物限度检查方法研究[J].中国药房,2011,22(33):3143-3145.
[5]	钱文静,张玫,袁耀佐. 盐酸特比萘芬凝胶微生物限度检查方法的验证[J].药物分析杂志,2008,28(12):2135-2139.
[6]	刘宁,张文婷. 克林霉素磷酸酯凝胶微生物限度检查方法的验证[J].药物分析杂志,2007,27(12):1991-1993.
[7]	周国华,傅小英. 医疗机构制剂检验基本操作指南[M]. 北京:人民军医出版社,2012:112-121.
[8]	李佩蓉,范秋汝. 药品微生物限度检验的误差影响因素[J]. 北方药学,2011,8(3):81-119.

[1]	国家药典委员会. 中华人民共和国药典2010年版二部[S].北京:中国医药科技出版社,2010:附录Ⅺ J108.
[2]	江燕,张春瑛,钱文忠. 红花油凝胶微生物限度检查方法的验证[J].中国药师,2010,13(4):591-592.
[3]	李近磊,王嘉怡,迟丹怡,等. 复方克林霉素凝胶微生物限度检查法的方法验证研究[J].中国药房,2010,21(25):2380-2382.
[4]	杨淑先,赵新霞,牛坡. 林可霉素利多卡因凝胶微生物限度检查方法研究[J].中国药房,2011,22(33):3143-3145.
[5]	钱文静,张玫,袁耀佐. 盐酸特比萘芬凝胶微生物限度检查方法的验证[J].药物分析杂志,2008,28(12):2135-2139.
[6]	刘宁,张文婷. 克林霉素磷酸酯凝胶微生物限度检查方法的验证[J].药物分析杂志,2007,27(12):1991-1993.
[7]	周国华,傅小英. 医疗机构制剂检验基本操作指南[M]. 北京:人民军医出版社,2012:112-121.
[8]	李佩蓉,范秋汝. 药品微生物限度检验的误差影响因素[J]. 北方药学,2011,8(3):81-119.

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Validation of method for microbial limit test of fast vertical liquid hand disinfectant gel

doi: 10.3969/j.issn.1006-0111.2014.05.014

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