包材微生物限度

如愿1

以前内包材微生物限度检查依据YBB，25版药典新增了，4401包材无菌及微生物限度检查，那包材的取样数量是不是还得依据YBB？还有图片上，“合并冲洗液，混匀，得供试液”怎么理解？是一个瓶子冲洗多次合并冲洗液，还是每个瓶子冲洗后，五个瓶子的冲洗液合并在一起？求各位大神解答

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wzzz2008

根据《国家药监局关于实施2025年版《中华人民共和国药典》有关事宜的公告》（2025年第32号）
三、自实施之日起，凡原收载于历版药典、局（部）颁标准的品种，本版《中国药典》收载的，相应历版药典、局（部）颁标准同时废止；本版《中国药典》未收载的，仍执行相应历版药典、局（部）颁标准，但应当符合本版《中国药典》的相关通用技术要求。经上市后评价撤销或者注销的品种，相应历版药典、局（部）颁标准废止。
YBB，应该是属于局颁标准。

所以，YBB，要继续执行，但要符合药典通则的要求。

机智鼠

关于包材微生物限度，25版药典4401新增了相关检查方法，但取样数量方面，若有YBB标准且其规定更具体、严格，可优先依据YBB。若无特殊要求，一般可参考药典中容器类等供试品检验量不少于5个的规定。

对于“合并冲洗液，混匀，得供试液”，是指每个瓶子用一定体积冲洗液冲洗后，将多个瓶子的冲洗液合并在一起，然后混匀得到供试液。例如若对5个瓶子取样，就是把这5个瓶子各自的冲洗液合并后混匀。具体操作可参考药典及相关标准操作规程。

【鼠鼠还在学习中，内容仅供参考（药搭GMP软件提供技术支持）】

wzzz2008

至于后面一个问题。
看你方法确认的情况。
每个瓶子多次冲洗的，和多个瓶子冲洗的，肯定都得合并。不然你冲洗的目的是干啥呢？总不能是洗瓶吧？

SingleUooU

我理解是多个瓶子冲洗后，冲洗液混合。一个瓶子冲洗多次，你确定还测的准吗？检测讲究的就是原汁原味吧

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greatwolf

检验方法依据药典，检验标准依据YBB。我是这样理解的。

玩家Lavi14

看书上字面意思我理解是每个瓶子冲洗后，五个瓶子的冲洗液合并在一起

oopppp

合并到一起，算一份样品，再取五个来合并到一起算做平行样。这个操作是增大取样量而已。