Sealing Validation for Medical devices


Starting to get Involved
Hello together,

I have a question regarding sealing validation.
We have equivalent(same model, same type) "4" welding machines that will be used for the same process.
I am planning to initiate the sealing validation process for those processes. But I am wondering if I have to create OQ and PQ for all machines. Or if it is possible to validate only 1 sealing machine which comprises the all machines? If it is possible, how can I document it ?

Thank you.


Super Moderator
Do you ask about "sealing" in the context of forming a sterile barrier system? Or do you ask about "welding" in the context of forming joints by means of e.g. laser or UV light?


Trusted Information Resource
If the machines used in the process are identical, and use common settings: It is unlikely that an OQ would need to be execute on each machine, as the OQ is focused on the process parameters. I would expect a PQ to be executed for each machine, as they are an obvious source of inherent variation in process outputs. For example, PQs are can be well-motivated for different work shifts using the same piece of equipment.

If there is a rationalization for not performing the same PQ using the diverse machines, I would expect that the rationale be able to withstand scrutiny. Sterile barriers are a "no-brainer" system that invites detailed scrutiny.


Super Moderator
ISO/TS16775:2021 gives an example in section that might fit your purpose to some extent:
[....] validate a second identical machine. A new machine always requires a new validation. IQ is specific to machine No. 2 to make sure that everything is properly installed, calibrated and the documentation is complete. For OQ, process development can be leveraged from the previous validation. The bracketing can be simplified, [...]. During PQ, three lots will be run to confirm that the process on machine No 2 is capable and reproducible meeting specifications. Each situation is unique, and manufacturers should carefully perform their own risk analysis.[...]
A rational for the validation [...] and the related worst-case considerations should be documented.
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