Validation Plastic Injection Molding Process protocol

[andrei iuganu]

Hello group,
I know that this topic has been addressed before, but I cannot find documentation that would help me create a document/protocol for the validation of a plastic mass injection process for the production of a plastic medical device.
Are any of you willing to help me with a file/document in this sense?

 

[chris1price]

I can't share documents with you, but I would suggest the following as a starting point:

IQ - Confirm tool meets URS and specifications, confirm metal dimensions, ensure tool fits moulding machine and services are available, ensure calibration of gauges and TMV is performed.

OQ - Perform First article inspection, run at high and low settings, consider shrinkage, assess capability, balance, operating window perform DoE if required, establish/confirm operating settings, establish documentation, training, maintenance.

PQ - Perform multiple (3) batches at typical operating conditions

Throughout, include rationale for sample sizes depending on risk assessment.

Also have a look at this thread:
Validation Guidance - Plastic Injection Molding Process

 

[andrei iuganu]

Thank you chris, but i search for practical example, document.

 

[Bev D]

No one is going to share that level of specificity with you. That would be sharing what is most assuredly proprietary information. It is also akin to doing your job for you for free. We will certainly answer specific questions and provide guidance. After reading the guidance provided by Chris what are your specific questions?

 

[andrei iuganu]

Bev D, thank you. i am aware about my request. i wanted only a model, not to somebody my job. i will ask specific question. thank u verry much.

 

[LUFAN]

Bev D, thank you. i am aware about my request. i wanted only a model, not to somebody my job. i will ask specific question. thank u verry much.

We purchased this procedure a while back. It's not fabulous or anything but does include a bunch of charts and graph examples on the things to look for.

In practically, we had to hire a consultant to setup and author protocols and reports for us as we found it a bit hard to implement.