validation will include visual inspection and conductivity assessment for our dedicated equipment. any suggestions on proof of concept work that could be undertaken for visual cleanliness? we cant apply a MACO as no therapeutic dose is known at this particular stage of the process so what would i compare the visible-residue limit with? can i just state what the visible residue limit is from proof of concept work? thanks
if you are using dedicated equipment for processing you need not go for any cleaning validation and need to verifiy visual criteria . Check the cleaning effecency by using white cloth .
I have a question about dedicated equipment. I am trying to conduct cleaning validation on some dedicated equipment. This is a dry manufacturing process, we have to use a detergent to clean some of the equipment. According to FDA guidelines dedicated equipment only needs to meet visual inspection cleanliness. But as we are using a detergent we have decided to go down the road of analytical methods to prove no residue of detergent is left.
If you use a detergent are you automatically making this equipment non-dedicated?. The problem is there is a huge difference of opinion here, all the manufacturing equipment is on a laboratory scale so this makes it very difficult to get enough of an area to swab or rinse samples for analysis.
The use of cleaning agents should not mean you lose the dedicated status on your equipment. Many process require a cleaning agent of some description (e.g. commodity such as NaOH or a formulated cleaner) to achieve sufficiently low carry over levels without impairing the dedicated claim. Where water can be used effectively, it is obviously desirable, but it is not always practical in terms of dissolving or moving the process residues. As a result it is frequently necessary to resort to cleaning agents and it makes sense to use analytical methods for the detergent residues, but they do need to be the correct ones for both the analyte and the sampling method.
I’d be happy to discuss further if you want to take it offline.
I am looking for some help, I am introducing a dishwasher to clean beakers, flasks used during API production. I will be using a detergent to clean.all ideas welcome. Where would be best to start.
I will be conduting validation on our dishwasher, and have no clue as to where to start. I see you have posted the question to the forum a while ago. Do you have any advice for me or perhaps a validation plan.