Hello to all - this is my first post after discovering the forum - could you help me out please.
I am trying to set in place a validation protocol OQ /PQ for the cleaning of blending tanks.
I have 2 x 5,000 litre stainless steel tanks which mix 70/30 IPA or IMS alcohol with WFI water.
At the end of the batch , the batch is exhausted from the blending vessel (all except any low volume residual).
Outside of validation I have determined that the process to achieve low residual carryover is to perform rinsing cycles.
70% alcohol (IPA) is mixed with 30% WFI to create a batch. This batch is mixed and subsequently pumped through to filling machines.
At the end of the batch , the 70/30 batch is exhausted through the pipework (all that remains is a residual).
Add 60 litres of WFI to rinse the blending vessel, pump this to waste.
Repeat this cycle 5 times.
I am measuring the alcohol peak using a GC machine.
The issue is the acceptance criteria that we should apply.
20ppm has been generally accepted as being a reasonably acceptable carry over.
Does anyone have any views they could share with me please?
The product is terminally irradiated and used for cleaning purposes in cGMP environments.