生物医药企业微生物限度检查操作规程.doc

生物医药企业微生物限度检查操作规程 　　 　版本号： 　A 　 修订号 　：0 0 　 生物医药企业微生物限度检查操作规程 　文件编号 　： 　ABC-RQ-20×× 编 制 　： 　审 核 　： 　校 订 　： 　批 准 　： 　发布日期： 　20××年 1 月 1 日 　 生效日期：20××年 1 月 1 日 　分发部门 ■总经理 ■常务副总 ■财务副总 ■工程副总 　■××××部 ■××××部 ■××××部 ■××××部 　■××××部 ■××××部 ■××××部 ■××××部 　 　I 目 　录 　 1 　计数方法 ································································ 1 　1.1 　 应用范围 ·································································· 1 　1.2 　 计数方法 ·································································· 1 　1.3 　 计数培养基适用性检查和供试品计数方法适用性检查 ········· 1 　1.4 　 菌种及菌液的制备 ······················································ 1 　1.4.1 　菌种 ················································································· 1 　1.4.2 　菌液制备 ··········································································· 1 　1.5 　 计数方法适用性检查 ··················································· 3 　1.5.1 　供试品制备 ········································································ 3 　1.5.1.1 　成品、辅料供试液的制备 ······························································· 3 1.5.1.2 　内包装膜、袋 ·············································································· 4 1.5.2 　接种和稀释 ········································································ 4 　1.5.2.1 　试验组 ······················································································· 4 1.5.2.2 　供试品对照组 ·············································································· 4 1.5.2.3 　菌液对照组 ················································································· 4 1.5.3 　供试品中微生物的回收 ························································· 5 　1.5.3.1 　平皿法 ······················································································· 5 1.5.3.2 　薄膜过滤法 ················································································· 5 1.6 　 结果判断 ·································································· 6 　2 　供试品的检查 ·························································· 6 　2.1 　 检验量 ·························