Determination of cleaning validation necessity

Dear all,

if a new product comes to plant, how to determine wheather there is

necessity of carring out cleaning validation?

what are the requirements to carry out cleaning validation?

Dear nil,

when a new product is going to be manufactured in a plant, if your approach is the "worst case " approach , you must perform the evaluations and calculations to decide if the new product is a new “worst case” as a contaminant, and if the new product (with its own combination of batch size, daily dosage and equipment train) as “contaminated oproduct” changes the contamination limits currently accepted.

Best regards


We have an equipment witch presented microbial proliferation in our validation study( in one of three batches), so, I would like ask you, ¿Is it necessary to run a complete cleaning validation to other three batches again, considering chemical residues, rinse and evaluation of microbial contamination? or ¿ It is possible to evaluate, after to do the adequate investigation, only the microbial proliferation in other batches of any product?

I really will appreciate your help.

hi gretta,
It would be better if you have cleared the issue of when did the microbial proliferation happen say for first batch or 2nd or 3rd. Re all these 3 batche staken in campaign? is nay non serial cleaning performed in between? are any bags used in the process (say FBD bags etc?)

An idea on these will help to make some conlusion and proceed further.

Take into conisderation that 3rd batch in campaign has microbial proliferation which means that the batch if manufactured in campaign should be studied for microbial proliferation after each campaign say after 2 batches then in next campaign after 3 batches so that to ensure that there is no microbial proliferation on the equipment before proceeding for next batch.

If bags are used check for the proper cleaning of the bags. A bag stored in improper condition after process shall lead to microbail proliferation
Check out in this way which is the root cause

Dear Gretta,

in my opinion the microbial proliferation does not invalidate the chemical cleaning. The presence of microorganisms is not correlated with the amount of chemical residues because the usual limits of chemical residues allow for plenty of nutrients for microorganisms (microorganisms grow even in the purified water we use as a final rinse). The problem is that to reach acceptable levels of microorganisms, most probably the whole cleaning procedure needs to be changed, and this is what then invalidates your chemical cleaning validation.

Best regards