Is Pre-cleaning Allowed?预清洗允许吗？？？

beiwei5du

如题：
Question: “Must a firm quantify the amount of residue on equipment surfaces in support of validating the cleaning procedure?”
Answer: “In validating the original cleaning procedure, a firm need not quantify the level of chemical contamination remaining after manufacturing a product and before cleaning during validation exercises. The firm must, however, ensure that they validate the proposed cleaning procedure as for routine use, and not pre-clean or otherwise attempt to make it easier for the procedure being validated to meet its cleaning objectives.”

So, the question is, are these initial steps described above a type of pre-cleaning that is not allowed under this FDA CGMP Note? If the answer is “Yes”, then we are in a lot of trouble. However, I think what the FDA is getting at is doing some kind of pre-cleaning in the validation protocols that is not ordinarily done. I think that as long as the pre-cleaning is part of the written procedure, as long as it is adequately specified/defined, and as long as it is challenged in the validation protocol, pre-cleaning should be acceptable.（只要预清洗满足一下基本要求：作为书面文件被正式规定，或者足够的说明和定义，或者在清洁验证方案中被挑战，预清洁是可以被接受的。）

beiwei5du

其实关于预清洗的问题涉及到清洗前是否对残留定量，同时也是上一个产品的批量是否影响清洁工艺（即改变上一个产品后，清洁工艺需不需要再验证的问题），那么如果预清洗采取清洁至目视合格（预清洁不验证），DHT验证是否还有必要？？？同时预清洗的延伸度如何规定？？？（比如我可以将前面的所有cleaning steps都定义为预清洗，而仅仅在最后使用一步rinse操作作为正式或者常规的清洁工艺，那么我实际上是将清洁验证的步骤缩短了）基于此，我认为某cleaning steps是否能纳入到预清洗（不验证），是基于其风险，如此说来，如果前面预清洁程序中的cleaning steps很关键（比如如果不严格清洁会有其他杂质产生），我是不能将其纳入到预清洗中，如果要纳入，预清洗也需要做验证（这个其实和没有预清洗是一样的呢）@谢大侠来了 @windy

windy

beiwei5du 发表于 2017-9-17 09:33
其实关于预清洗的问题涉及到清洗前是否对残留定量，同时也是上一个产品的批量是否影响清洁工艺（即改变上一 ...

如果设备出空后立即执行gross Cleaning（Pre-Cleaning），无须确定DHT

套路

目前我正好需要，看一下，谢谢分享

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