无菌检查隔离器在无菌检查中的应用
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摘要
无菌检查隔离器是一种为无菌检查试验提供无菌环境的设备,可较好地防止微生物污染待测样品,避免试验用品和辅助设备的污染,提高无菌检查试验结果的准确性。随着制药行业对无菌环境要求的不断提高,无菌检查隔离器已在全球制药行业得到广泛应用。本文主要对无菌检查隔离器的发展、分类、灭菌、工艺、验证、配套设备及在无菌检查中的应用作一综述,并将无菌隔离器与传统无菌检查室进行比较。
As a device which provides sterile environment,isolator may well prevent samples from microbial pollution and avoid the occurrence of a false positive so as to improve the accuracy of aseptic examination. With the increasing requirement for sterile environment in pharmaceutical industry,sterility test isolator has been used by more and more pharmaceutical companies in recent years. This review mainly discusses the development,classification,sterilization,process,verification,supporting equipment and application in the sterility test of sterile test isolator,and compares it with the traditional sterile examination room.
As a device which provides sterile environment,isolator may well prevent samples from microbial pollution and avoid the occurrence of a false positive so as to improve the accuracy of aseptic examination. With the increasing requirement for sterile environment in pharmaceutical industry,sterility test isolator has been used by more and more pharmaceutical companies in recent years. This review mainly discusses the development,classification,sterilization,process,verification,supporting equipment and application in the sterility test of sterile test isolator,and compares it with the traditional sterile examination room.
引文
[1]Chinese Pharmacopoeia Commission.Pharmacopoeia of People's Republic of China(VolⅢ)[S].Beijing:China Medical Science Press,2015:General Requirement 76-80.(in Chinese)国家药典委员会.中华人民共和国药典(三部)[S].北京:中国医药科技出版社,2015:通则76-通则80.
[2]国家食品药品监督管理局药品认证中心.无菌药品GMP指南[S].北京:中国医药科技出版社,2011:318-338.
[3]Council of Experts.USP NF(Vol 1)[S].Washington,D C:The Board of Trustees,2008:85-90.
[4]Chinese Pharmacopoeia Commission.Pharmacopoeia of People's Republic of China(VolⅣ)[S].Beijing:China Medical Science Press,2015:388-393.(in Chinese)国家药典委员会.中华人民共和国药典(四部)[S].北京:中国医药科技出版社,2015:388-393.
[5]PIC/S P012-03 2007.Recommendation on sterility testing[S].2007-09-25.
[6]罗辉艳,严东珍,刘家媛,等.无菌隔离器灭菌效果研究[J].中国设备工程,2017,3(下):78-82.
[7]PDA TR 34.Design and validation of isolator systems for the manufacturing and testing of Health care products[S].2001-10-09.
[8]吴文蕾,程锦生,郑金旺.隔离技术在无菌检查中的应用[J].化工与医药工程,2014,35(5):31-35.
[9]吴文蕾,程锦生,郑金旺.无菌检查隔离器的应用[J].中国医药工业杂志,2015,46(5):546-551.
[10]ZHANG T J,HAN W T.Application of aseptic isolation technology in pharmaceutical industry[J].Coal Chem Industry,2013,36(7):124-127.(in Chinese)张铁军,韩文涛.无菌隔离技术在制药行业中的应用[J].煤炭与化工,2013,36(7):124-127.
[11]张启阳.隔离技术在制药行业中的应用趋势分析[J].中国高新技术企业,2012(24):63-64.
[12]陈允裔.隔离技术在无菌原料药生产过程中的应用[J].现代制造,2013(2):26-28.
[13]PIC/S 012-03 2007.Recommendation on Isolators used for aseptic processing and sterility testing》[S].2007-09-25.
[14]Chinese Pharmacopoeia Commission.Pharmacopoeia of People's Republic of China(VolⅣ)[S].Beijing:China Medical Science Press,2015:398-400.(in Chinese)国家药典委员会.中华人民共和国药典(四部)[S].北京:中国医药科技出版社,2015:398-400.
[15]GAO H Y,DING E F,ZHAO L Y,et al.Technical requirements of validation of sterility testing isolator in USP[J].Pharm Utical Engi Design,2010,31(2):29-33.(in Chinese)高海燕,丁恩峰,赵丽雅,等.USP对无菌检验隔离器验证的技术要求[J].化工与医药工程,2010,31(2):29-33.
[16]宋勋.药品生产中的隔离操作技术[J].现代制造,2011(2):23-28.
[17]Council of Experts.USP(Vol 1)[S].Washington,D C:The Board of Trustees,2008:399-402.
[18]AKERS J,AGALLOCO J.Isolators:validation and sound scientific judgment[J].J Pharm Sci Technol,2000,54(2):110-111.
[19]BERNUZZI M L.Decontamination and validation of isolators for sterility testing[J].Biomed Instrum Technol,2016,50(s3):27-33.
[20]PIC/S secretariat.PIC/S isolators used for aseptic processing and sterility testing(PI 014-3)[S].(2007-09-25)[2018-04-28].https://wenku.baidu.com/view/8b59243a580216fc700afddc.html.
[21]Council of Experts.USP(Vol 1)[S].Washington,D C:The Board of Trustees,2008:665-668.
[22]张庆基.隔离器技术应用及国内外药典有关无菌检查法对洁净环境要求的比较[J].中国药品标准,2003,4(1):63.
[23]Chinese Pharmacopoeia Commission.Pharmacopoeia of People's Republic of China(VolⅣ)[S].Beijing:China Medical Science Press,2015:136-140.(in Chinese)国家药典委员会.中华人民共和国药典(四部)[S].北京:中国医药科技出版社,2015:136-140.
[2]国家食品药品监督管理局药品认证中心.无菌药品GMP指南[S].北京:中国医药科技出版社,2011:318-338.
[3]Council of Experts.USP NF(Vol 1)[S].Washington,D C:The Board of Trustees,2008:85-90.
[4]Chinese Pharmacopoeia Commission.Pharmacopoeia of People's Republic of China(VolⅣ)[S].Beijing:China Medical Science Press,2015:388-393.(in Chinese)国家药典委员会.中华人民共和国药典(四部)[S].北京:中国医药科技出版社,2015:388-393.
[5]PIC/S P012-03 2007.Recommendation on sterility testing[S].2007-09-25.
[6]罗辉艳,严东珍,刘家媛,等.无菌隔离器灭菌效果研究[J].中国设备工程,2017,3(下):78-82.
[7]PDA TR 34.Design and validation of isolator systems for the manufacturing and testing of Health care products[S].2001-10-09.
[8]吴文蕾,程锦生,郑金旺.隔离技术在无菌检查中的应用[J].化工与医药工程,2014,35(5):31-35.
[9]吴文蕾,程锦生,郑金旺.无菌检查隔离器的应用[J].中国医药工业杂志,2015,46(5):546-551.
[10]ZHANG T J,HAN W T.Application of aseptic isolation technology in pharmaceutical industry[J].Coal Chem Industry,2013,36(7):124-127.(in Chinese)张铁军,韩文涛.无菌隔离技术在制药行业中的应用[J].煤炭与化工,2013,36(7):124-127.
[11]张启阳.隔离技术在制药行业中的应用趋势分析[J].中国高新技术企业,2012(24):63-64.
[12]陈允裔.隔离技术在无菌原料药生产过程中的应用[J].现代制造,2013(2):26-28.
[13]PIC/S 012-03 2007.Recommendation on Isolators used for aseptic processing and sterility testing》[S].2007-09-25.
[14]Chinese Pharmacopoeia Commission.Pharmacopoeia of People's Republic of China(VolⅣ)[S].Beijing:China Medical Science Press,2015:398-400.(in Chinese)国家药典委员会.中华人民共和国药典(四部)[S].北京:中国医药科技出版社,2015:398-400.
[15]GAO H Y,DING E F,ZHAO L Y,et al.Technical requirements of validation of sterility testing isolator in USP[J].Pharm Utical Engi Design,2010,31(2):29-33.(in Chinese)高海燕,丁恩峰,赵丽雅,等.USP对无菌检验隔离器验证的技术要求[J].化工与医药工程,2010,31(2):29-33.
[16]宋勋.药品生产中的隔离操作技术[J].现代制造,2011(2):23-28.
[17]Council of Experts.USP(Vol 1)[S].Washington,D C:The Board of Trustees,2008:399-402.
[18]AKERS J,AGALLOCO J.Isolators:validation and sound scientific judgment[J].J Pharm Sci Technol,2000,54(2):110-111.
[19]BERNUZZI M L.Decontamination and validation of isolators for sterility testing[J].Biomed Instrum Technol,2016,50(s3):27-33.
[20]PIC/S secretariat.PIC/S isolators used for aseptic processing and sterility testing(PI 014-3)[S].(2007-09-25)[2018-04-28].https://wenku.baidu.com/view/8b59243a580216fc700afddc.html.
[21]Council of Experts.USP(Vol 1)[S].Washington,D C:The Board of Trustees,2008:665-668.
[22]张庆基.隔离器技术应用及国内外药典有关无菌检查法对洁净环境要求的比较[J].中国药品标准,2003,4(1):63.
[23]Chinese Pharmacopoeia Commission.Pharmacopoeia of People's Republic of China(VolⅣ)[S].Beijing:China Medical Science Press,2015:136-140.(in Chinese)国家药典委员会.中华人民共和国药典(四部)[S].北京:中国医药科技出版社,2015:136-140.