Hi everyone
i have some question about cleaning validation,
if i change the product batch size,Do I have to re-validation new batch size?
may i run a smallest batch size on behalf of worst case?
i have 4 product(ABCD) at same process,according to customer requirements.
thanks all
cdpro223@yahoo.com.tw
No not required.
You have to revalidate only in case of a smallest batch size since the ARL decrease reducing the batch size.
Yes, you should re-validate.
Increase of batch sizes changes the limit of acceptance criteria.
This is because as your batch increase the contact surface area of your equipment will increase.
Not required.
The acceptance criteria will be tightened when the batch size is smaller.
You will get relaxed limits when the batch size is increased.
Hence this is not required.
You can check by applying the for setting limits rinse and swab, you get the limit higher than smaller batch size .
If you write your batch size and drug and equipment details we will calculate the limits.
Regards,
Bujji Reddy Kanchi.
Hetero drugs-Vizag.
9676749937
actually i think so too.
but i don’t find any literature support this ideal.
at smallest batch size the criteria is lowest and best worst case.
in the same equipment contact surface area and same product,
just different batch size,why can’t use the smallest batch size criteria?
[quote=bujjikanchi]Not required.
The acceptance criteria will be tightened when the batch size is smaller.
You will get relaxed limits when the batch size is increased.
Hence this is not required.
You can check by applying the for setting limits rinse and swab, you get the limit higher than smaller batch size .
If you write your batch size and drug and equipment details we will calculate the limits.
Regards,
Bujji Reddy Kanchi.
Hetero drugs-Vizag.
9676749937[/quote]