Process Validation

6 posts / 0 new
Last post
lizzy
lizzy's picture
Process Validation

Can anyone tell me how often a validation of aseptic processes should be conducted? Is once enough or should it be repeated on regular basis?

Bettye
Bettye's picture
lizzy wrote:Can anyone tell

lizzy wrote:

Can anyone tell me how often a validation of aseptic processes should be conducted? Is once enough or should it be repeated on regular basis?

My thoughts are that it should be repeated, but I'm not sure how often, sort of like calibration of equipment...

l-gold
l-gold's picture
lizzy wrote:Can anyone tell

lizzy wrote:

Can anyone tell me how often a validation of aseptic processes should be conducted? Is once enough or should it be repeated on regular basis?
l-gold
l-gold's picture
lizzy wrote:Can anyone tell

lizzy wrote:

Can anyone tell me how often a validation of aseptic processes should be conducted? Is once enough or should it be repeated on regular basis?

To my knowledge, as long as the process parameters and equipment does not change at all, and the final product is properly quality tested with no problems, revalidation is neccessary every three years.

jachmoody
jachmoody's picture
I believe you'll find

I believe you'll find guidance on FDA'S web site--most of the time 3 trials are expected for establishing repeatability and so statistical analysis can be done.

lizzy wrote:

Can anyone tell me how often a validation of aseptic processes should be conducted? Is once enough or should it be repeated on regular basis?
Deepu
Deepu's picture
lizzy wrote:Can anyone tell

lizzy wrote:

Can anyone tell me how often a validation of aseptic processes should be conducted? Is once enough or should it be repeated on regular basis?

I hope you mean media fill by aseptic process validation.
In that case you have to have three successful consecutive media fills using SCDM (for aerobes)for lowest as well as highest fill.
After that you have to repeat every six months.This study you can alternate with highest or lowest fills.
In case if you are using nitrogen flushing you have to use Fluid thioglycollate medium as the media.
For acceptance level you can refer PIC/S guideline for aseptic process validation