Hello,
Would you consider a difference between a clean line and a wash line? I was always under the impression that final clean was a special process that required a validation, using ISO 14971 as guidance. Our company has a "clean line" but it's more of a wash/degreaser kind of situation, IMO. We do not claim to perform final clean for any of our customers nor do they require it. We are merely getting crap from our shop floor off before we ship to our customer (who is not the end user and they are responsible for performing any kind of final clean). We have a validation on file that partially follows the ISO guideline but is mostly concentrated on ensuring the contact materials from our floor are removed, so we are not doing things like the bioburden test.
Our sister company was auditing us and said this was unacceptable and our cleaning validation should follow ISO 14971 completely. There's just no way we would pass some of those tests, because again, I don't believe we are set up as a clean line.
Does anyone have any insight into this?
Would you consider a difference between a clean line and a wash line? I was always under the impression that final clean was a special process that required a validation, using ISO 14971 as guidance. Our company has a "clean line" but it's more of a wash/degreaser kind of situation, IMO. We do not claim to perform final clean for any of our customers nor do they require it. We are merely getting crap from our shop floor off before we ship to our customer (who is not the end user and they are responsible for performing any kind of final clean). We have a validation on file that partially follows the ISO guideline but is mostly concentrated on ensuring the contact materials from our floor are removed, so we are not doing things like the bioburden test.
Our sister company was auditing us and said this was unacceptable and our cleaning validation should follow ISO 14971 completely. There's just no way we would pass some of those tests, because again, I don't believe we are set up as a clean line.
Does anyone have any insight into this?
