2015版药典培养基适用性验证.pdf

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1、精心整理培养基验证文件制药有限公司制药有限公司验证立项申请表验证立项题目计数培养基适用性检查的验证立项编号TS-YZ-2522-01验证形式验证立项部门质量部申请日期年月日验证对象计数培养基适用性验证目的及验证内容需氧菌、霉菌及酵母菌计数用的培养基应进行培养基的适用性检查。本次验证的目的是确认胰酪大豆胨琼脂培养基和沙氏葡萄糖琼脂培养基是否适合需氧菌、霉菌及酵母菌数测定。主管部门审核意见同意对计数培养基适用性检查试验方案进行验证。年月日验证文件名称验证文件编码计数培养基适用性检查验证方案TS-YZ-2522-01 精心整理对验证方案的编制及实施要求验证方案编制应科学，合理，方法应切实可行，实施必

2、须按照方案进行。验证总负责人批准经审核批准对计数培养基适用性检查进行验证。签字：年月日验证方案的审批证方案目录1、概述2、验证目的3、验证范围4、验证项目小组成员及职责5、验证合格标准6、试验材料7、菌液制备8、适用性检查9、验证记录10、验证结论及综合评价计数培养基适用性检查的验证方案起草部门签名日期化验室质量部批准部门签名日期质量部验证总负责人文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档

3、编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B

4、7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P1

5、0 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3

6、文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U

7、2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9

8、P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8

9、V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3精心整理1.验证目的：需氧菌、霉菌及酵母菌计数用的培养基应进行培养基的适用性检查。本次验证的目的是确认胰酪大豆胨琼脂培养基和沙氏葡萄糖琼脂培养基是否适合需氧菌、霉菌及酵母菌总数测定。2.参照标准：中国药典 2015 年版四部 1105 非无菌产品微生物限度检查法。3.验证项目：胰酪大豆胨琼脂培养基和沙氏葡萄糖琼脂培养基的适用性检查。4.验证小组人员及职责：人员组成姓名部门职务/职称职责组长质量部副部长负责验证期间各部门的协调及整个验证过程的具体实施。成员化验室主任负责验证方案的起草及具体实施，确保验证过程能按

10、方案规定的程序进行，负责各种验证资料（检查结果）的整理，负责验证报告的编写。化验室化验员化验室化验员负责验证方案的审核及批准；负责出具检验报告；审查验证报告及发放验证报告；负责验证文件的管理化验室化验员负责验证报告的编写规范；审查验证报告及发放验证报告。5.合格标准：被检固体培养基上的菌落平均数与对照培养基上的菌落平均数的比值应在0.5 2范围内，且菌落形态大小与对照培养基上的菌落一致。6.试验材料：6.1.被验证产品：胰酪大豆胨琼脂培养基、沙氏葡萄糖琼脂培养基。6.2.仪器设备：6.2.1.YXQ-LS-100G 型立式压力蒸汽灭菌器6.2.2.GHT-00 双人净化工作台6.2.3.BSC

11、-110011A2-X 生物安全柜文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3

12、O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T

13、1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5

14、P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9

15、Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ

16、7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3

17、N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3精心整理6.2.4.MJ-250I型霉菌培养箱(2025)6.2.5.LRH-250 生化培养箱(3035)6.2.6.电热恒温干燥箱6.2.7 微波炉6.3.验证用培养基名称生产厂家批号6.4.验证用菌株：(第代)7.菌液制备按

18、6.4规定程序培养各试验菌株。取金黄色葡萄球菌、铜绿假单胞菌、枯草芽孢杆菌、白色念珠菌的新鲜培养物，用 pH7.0 无菌氯化钠-蛋白胨缓冲液制成约为50100cfuml 的菌悬液；取黑曲霉的新鲜培养物加入 35ml 含 0.05%（ml/ml）聚山梨酯 80 的 pH7.0 无菌氯化钠-蛋白胨缓冲液，将孢子洗脱。然后，采用适宜的方法吸出孢子悬液至无菌试管内，用含0.05%（ml/ml）聚山梨酯 80 的 pH7.0 无菌氯化钠-蛋白胨缓冲液制成约为50100cfuml 的黑曲霉孢子悬液。8.适用性检查：8.1.取金黄色葡萄球菌、铜绿假单胞菌、枯草芽孢杆菌的菌液（50100cfu/ml）各 1m

19、l，每株试验菌平行制备 2 个平皿，分别注入 2 个无菌平皿中，立即倾注胰酪大豆胨琼脂培养基，并作阴性对照，混匀，凝固，置 3035培养 24小时，计数；取白色念珠菌的菌液（50100cfu/ml）各 1ml，分别注入 2 个无菌平皿中，立即倾注沙氏葡萄糖琼脂培养基，并作阴性对照，混匀，凝固，置 2025培养 72小时，计数；取黑曲霉菌的菌液（50100cfu/ml）1ml，注入无菌平皿中，立即倾注验证菌株培养基培养温度培养时间（小时）文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8

20、V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G

21、2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4

22、I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3

23、O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T

24、1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5

25、P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9

26、Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3精心整理沙氏葡萄糖琼脂培养基，每株试验菌平行制备2 个平皿，并作阴性对照，混匀，凝固，置 2025培养 168小时，计数。8.2.取金黄色葡萄球菌、铜绿假单胞菌、枯草芽孢杆菌的菌液（50100cfu/ml）各 1ml，分别注入无菌平皿中，立即倾注胰酪大豆胨琼脂对照培养基，每株试验菌平行制备2 个平皿，并作阴性对照，混匀，凝固，置 3035培养 24小时，计数；取白色念珠菌的菌液（50100cfu/ml）各 1ml，分别注

27、入无菌平皿中，立即倾注沙氏葡萄糖琼脂对照培养基，每株试验菌平行制备2 个平皿，并作阴性对照，混匀，凝固，置2025培养 72 小时，计数；取黑曲霉菌的菌液（50100cfu/ml）各 1ml，分别注入无菌平皿中，立即倾注沙氏葡萄糖琼脂对照培养基，每株试验菌平行制备2 个平皿，并作阴性对照，混匀，凝固，置2025培养 168 小时，计数。9.验证记录10.验证结论及综合评价评价人：日期：文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4

28、I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3

29、O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T

30、1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5

31、P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9

32、Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ

33、7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3

34、N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3精心整理附表 1：计数培养基适用性检查验证记录试验时间年月日完成时间年月日验证菌株平皿号验证培养基组（cfu ml）阴性对照（cfu ml）对照培养基组(cfu ml)阴性对照（cfu ml）菌落平均数的比值（应在 0.5 2 范围大肠埃希菌(培养 3 天计数)1-2-平均值金黄色葡萄球菌(培养 3 天计数)1-2-平均值枯草芽孢杆菌(培养 3 天计数)1-2-平均值白色念珠菌(培养 5 天开始计数)1-2-平均值黑曲霉菌1-文档编码:CJ7T1G2U2B7 HX3N5P

35、4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z

36、3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7

37、T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N

38、5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B

39、9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:C

40、J7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX

41、3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3精心整理复核人试验人复核人试验人(培养 5 天开始计数)2-平均值结论文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O

42、8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1

43、G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P

44、4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z

45、3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7

46、T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N

47、5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B

48、9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3精心整理验证报告的审批验证报告1.验证目的：需氧菌、霉菌及酵母菌计数用的培养基应进行培养基的适用性检查。本次验证的目的是确认胰酪大豆胨琼脂培养基和沙氏葡萄糖琼脂培养基是否适合需氧菌、霉菌及酵母菌总数测定。2.参照标准：中国药典 2015 年版四部 1105 非无菌产品微生物限度检查法。3.验证项目：胰酪大豆胨琼脂培养基和沙氏葡萄糖琼脂培养基的适用性检查。4.验证小组人员及职责：人员组成姓名部门职务/职称职责组长质量部副部长负责验证期间各部门的协调及整个验证过程的具体实施。成员化验室主任负责验证方案的

49、起草及具体实施，确保验证过程能按方案规定的程序进起草部门签名日期化验室质量部批准部门签名日期质量部验证总负责人文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V

50、3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2U2B7 HX3N5P4I9P10 ZD2B9Z3O8V3文档编码:CJ7T1G2