Once upon a time, a company decided to improve their packaging sealing process. They selected equipment with a new technology that would process more product in less time with improved seal characteristics. The equipment was specified and approved. A qualification project team was formed and prepared a validation project plan that described how the revised processes would be developed and tested, how the equipment would be evaluated, its short term capability assessed, how the entire process would be revalidated, and who will be responsible for testing.
Graham - if I wave, and if you do - we should see each other . . .
This is uncannily close to how we do it. Which is a bit of a relief - presuming that this article is advocating a good way / the right way / best practice?
Anyway, nicely written and clearly understandable.
I am bit surprised that you’ve talked about three runs of PQ for packing equipment. But as per my knowledge, only one PQ run is sufficient to verify the functionality of equipment as per user requipments or as intended.
The three runs of PQ is possible when the it is clubbed with Process Validation (of a product). But most of the time it is desirable that the equipment should get qualified before taking up process validation batches.
Dear All,
I kindly ask for your help. We are EU manufacturer of packaging machine. We have a request to deliver a machine within EU to wrap. We have been asked also for PQ,IQ,OQ. Where this validiation process has to be carried out. In the local country where we deliver or where we manufacture the machine?Which companies can be contacted in order to process the validiation documentation? Waiting for your reply, best regards,
Peter
Good article, but I have one issue.
I’m working on a packaging machine at the moment which involves heat sealing, now we are concerned with testing seal strength but also concerned with testing the product (if pharmaceutical).
We are going to determine if the heat sealing has any effect on the product with the tray/tub/blister, to do this we are:
Sealing a number of trays at the highest temperature
Sealing a number of trays at the lowest temperature
Not sealing a number of trays.
All samples within the tray/tub/blister will be QC tested to determine if the heat generated during the sealing process has any effect on your product.
Dear gokeefe,the link is corrupted.Could you please re-link again?I really need help for my audit answer.
[quote=gokeeffe]Packaging Sealing Validation - A Simple Example
Introduction
Once upon a time, a company decided to improve their packaging sealing process. They selected equipment with a new technology that would process more product in less time with improved seal characteristics. The equipment was specified and approved. A qualification project team was formed and prepared a validation project plan that described how the revised processes would be developed and tested, how the equipment would be evaluated, its short term capability assessed, how the entire process would be revalidated, and who will be responsible for testing.