Medical Device : Pouch bag sealing validation

[idarosle]

Q : We just start with validation for about 2 years & I am still new in this dept.
We have many types of machine like endless sealer machine (to seal pouch bag).
We validate IQ, OQ, PQ accordingly, but the thing is, OQ we test until 25 conditions (5temperature & 5 sealing time).Seal strength test show not achive spec for some extreme condition (too low/too high setting) .
How do we define "worst case testing"?
I received 1 observation asking "how do you define worst case testing"
What is the meaning of worst case testing?
Can someone help me?

Thank you....

[DURGA PRASAD]

Worst case validation approach:

This approach begins with medical packing when transported to the client site should not lose its packing integrity.
Now you start your procedure by giving your Low, Medium and High sealing strength parameters.

Selected 150 such pouches before they are sealed.Fill with your product material.

-First 50 pouches should be packed with low sealing strength.
-Second 50 with medium sealing strength.
-Third 50 with High sealing strength.

Mark each pouch with proper material label and on back side number each container and attach a “ WORST CASE VALIDATION” LABLE.

Pack each of the container as per packing guidelines and send to your distributor sites normally in your regular logistic procedure.

Ask them to handle these packs as they handle regularly and ask them not to ship to anywhere to user.
After 10 days recall all the packs to your site.

That means the packs have traveled already twice its normal distance, have been handled at ware house for 10 days.

Now test the integrity of each pack. You must have 99% result.

I gave you this brief idea , this is the way we test our latest LVP’s in heat inducted sealed bags and we later test the sterility of each bag with SCD and Tryptose media.

Regards

[Bashevitz]

I have a simple validation report on how to test and reason towards an operational area on a validatable medsealer.

Let me know if need to see it

/pontus

[gokeeffe]

I have a simple validation report on how to test and reason towards an operational area on a validatable medsealer.

Let me know if need to see it

/pontus

It would be great if you could upload it to our templates section:
http://www.askaboutvalidation.com/fo...-PRESENTATIONS

[Bashevitz]

Ok, will do.

Please bear in mind that I am new to this, mechanical engineer, and the validation of the Medseal is done in combination with a Barex-laminate.

/pontus

- can´t upload it, I get a message where it says the file is not valid - anyone else experiencing the same problem?