冻干制剂出箱后澄清度不合格？！

zzj76122

冻干完成后澄清度不合格（浊度超标）。主要原因:①污染（如：油污染、杂质污染、产品的交叉污染）②预冻速度的快慢③产品本身的性状所决定的

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zzj76122 发表于 2013-4-28 08:32
冻干完成后澄清度不合格（浊度超标）。主要原因:①污染（如：油污染、杂质污染、产品的交叉污染）②预冻速度 ...

原料药性质是不太稳定，但从配液到开始冻干时间也很短，影响应该不是很大，我们分析觉得预冻速率有问题

其实偶很淡定

应该不是甘露醇的问题

魅力暴君

没有实际结果，我也遇到同样的问题，其实和预冻的快慢也有关系的，会影响晶型，从而影响复溶效果，与胶塞、冻干机油泄漏没有什么关系。

樟子松

路过学习   

cjtyyh

我建议你做个甘露醇空白对比了看看。

phyllis7

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小米饭

楼主楼主解决了吗  和我们一样一样的  求指教呀

snowheavyfly

是不是酸碱度的问题，你应该上图，看看是什么样的

爱死寂寞人12

顺便也请教一下大神，冻干前澄清度合格，冻干后有一定少数量不合格，抽检能查到。