{"title":"使用ISO 14644-1和EU GGMP附录1第2部分:实际应用的制药洁净室分级","authors":"T. Eaton","doi":"10.37521/ejpps.24402","DOIUrl":null,"url":null,"abstract":"Classification of cleanrooms and clean zones associated with the manufacture of medicinal products has been assessed in two articles. The first article discussed the classification requirements and principles associated with ISO 14644-1 and Annex 1 of the EU GGMP, and a suitable classification test method for aseptic manufacturing was derived. This second article considers the practical application of the method for the classification of a pharmaceutical cleanroom, and isolator located within it.\n\nKey words: Cleanroom classification, ISO 14644-1, EU GGMP Annex 1","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"83 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2020-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"4","resultStr":"{\"title\":\"Pharmaceutical Cleanroom Classification using ISO 14644-1 and the EU GGMP Annex 1\\nPart 2: Practical Application\",\"authors\":\"T. Eaton\",\"doi\":\"10.37521/ejpps.24402\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Classification of cleanrooms and clean zones associated with the manufacture of medicinal products has been assessed in two articles. The first article discussed the classification requirements and principles associated with ISO 14644-1 and Annex 1 of the EU GGMP, and a suitable classification test method for aseptic manufacturing was derived. This second article considers the practical application of the method for the classification of a pharmaceutical cleanroom, and isolator located within it.\\n\\nKey words: Cleanroom classification, ISO 14644-1, EU GGMP Annex 1\",\"PeriodicalId\":300408,\"journal\":{\"name\":\"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES\",\"volume\":\"83 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2020-02-10\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"4\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.37521/ejpps.24402\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.37521/ejpps.24402","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Pharmaceutical Cleanroom Classification using ISO 14644-1 and the EU GGMP Annex 1
Part 2: Practical Application
Classification of cleanrooms and clean zones associated with the manufacture of medicinal products has been assessed in two articles. The first article discussed the classification requirements and principles associated with ISO 14644-1 and Annex 1 of the EU GGMP, and a suitable classification test method for aseptic manufacturing was derived. This second article considers the practical application of the method for the classification of a pharmaceutical cleanroom, and isolator located within it.
Key words: Cleanroom classification, ISO 14644-1, EU GGMP Annex 1
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