Rinser Verification and Validation

Hi all, I am hoping someone can help me out with this. During our BRC audit the auditor asked why we had chosen 1.5bar pressure as our rinser pressure. We had carried out no verification exercises but had taken the manufacturers advice. We currently carry out validation exercises in which we spike bottles with foreign material to ensure they are removed during rinsing. I just wanted to make sure that I have the right idea in mind for the verification exercise as I am writing the procedure. A matrix of all bottle sizes and shapes for each line is made up. We then choose the smallest, middle and largest bottle for each shape and use these for our trials. We run the line at normal production speed and observe the rinsing at 1.5 bar pressure, we then slowly drop the pressure and observe until rinsing is no longer effective, then repeat by increasing pressure. We then will have an upper and lower limit which will effectively rinse bottles. Does this sound correct? Thanks, Jade

Hi...

You can take a video to shown to the auditor which is the best and effective rinsing pressure from the low , middle and high pressure.

So that the auditor understand why you choose that pressure for rinsing.

Thank you

Hi all, I am hoping someone can help me out with this. During our BRC audit the auditor asked why we had chosen 1.5bar pressure as our rinser pressure. We had carried out no verification exercises but had taken the manufacturers advice. We currently carry out validation exercises in which we spike bottles with foreign material to ensure they are removed during rinsing. I just wanted to make sure that I have the right idea in mind for the verification exercise as I am writing the procedure. A matrix of all bottle sizes and shapes for each line is made up. We then choose the smallest, middle and largest bottle for each shape and use these for our trials. We run the line at normal production speed and observe the rinsing at 1.5 bar pressure, we then slowly drop the pressure and observe until rinsing is no longer effective, then repeat by increasing pressure. We then will have an upper and lower limit which will effectively rinse bottles. Does this sound correct? Thanks, Jade

^^^^(red) -

product/process/step status unknown but one possible response might simply be "Best Practice" as defined by Equipment Manufacturer.

Thanks Afi and Charles,

Charles, we tried to get away with that response but the auditor was still not convinced that we hadn't done our own verification.

We will take plenty videos and pictures whilst doing the exercise.

Jade

Thanks Afi and Charles,

Charles, we tried to get away with that response but the auditor was still not convinced that we hadn't done our own verification.

 

We will take plenty videos and pictures whilst doing the exercise.

 

Jade

It often depends on the context. Obviously if the Rinser was a CCP then Validation is involved.