根据PDA TR29的内容，通常清洁验证中不考虑辅料的限度，因此计算残留共用面积时也不要考虑。
“Unless the excipient has some kind of unusual toxicity, limits are generally not set for excipients ina cleaning validation protocol. A case where limits may be set for excipients is where the excipientis known to have a significant effect on the performance of the next manufactured product, such ascomplexing with
the API to reduce bioavailability. However, it should be recognized that in all cases,residues of excipients after cleaning should be such that the equipment is visually clean. A surfacewhich is not “visually clean”due to a high level of an excipient should be generally considered a cleaningvalidation failure.
除非辅料有某种不寻常的毒性, 清洁验证方案中一般不设定辅料的限度。当已知辅料对下一个生产产品的性能有重大的影响时, 才需要设定辅料的清洁限度, 如与API 结合降低了生物利用度。然而，应注意在所有情况下，清洁后辅料残留应满足设备目视洁净的要求。一由于大量辅料存在造成表面不符合目视洁净要求，则通常认为清洁验证是失败的。”
如果一个产品辅料一个产品API那么他们之间，相互的共线面积不同怎么处理呀？我看很多就直接把接触API的就作为使用设备，难道日常生产，都是API和API共线，辅料和辅料共线，不存在API和辅料共线的情况？
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