4 replies to this topic

[carine]

Hi, we are going to remove the catridge filter in our proocess, this is because we feel that make no diffrence with or without catridge filter. Any suggestion what are the validtion i should do for the whole process after the removing of catridge process? Appreciate if anybody got experience at the situation above, and drop her/his valuable comments here.

[dgsorg]

Unsure of what your cartridge filter is supposed to be removing from the process, but you should be able to test process with and without filter and compare ppm. If there is no significant difference, you should be okay to remove filter (although I might suggest trying a different filter to see if it makes a difference). Document results and periodically re-test to confirm initial results. Always document the results so that inspectors and auditors know that you are aware of the removal and can justify it.

Hope that helps,
dgsorg

Hi, we are going to remove the catridge filter in our proocess, this is because we feel that make no diffrence with or without catridge filter. Any suggestion what are the validtion i should do for the whole process after the removing of catridge process? Appreciate if anybody got experience at the situation above, and drop her/his valuable comments here.

[carine]

thanks, it is helpful indeed!

[carine]

I have done up a process validation report by removing catridge filter, appreciate if anyone of u drop ur valuable comments here.

Attached Files

•  Process Validation Report.doc   30.5KB   12 downloads

[dgsorg]

That looks pretty good to me. Now, I would suggest repeating the verification test periodically and documenting it so that the validation remains current.

Regards,
dgsorg

I have done up a process validation report by removing catridge filter, appreciate if anyone of u drop ur valuable comments here.