Package validation on a different product in an already validated package?

B

Biobry

#1
Hello, I'm new to the quality system work and have been asked to take over a lot of the package validation work, so maybe someone can help me out with this question. We have a device for which the packaging validation work has already been completed. It is a multi-layer wound care device. We added another layer to it to make a new product and we will be packaging the new product in the same packaging (poly/poly pouch). At what point does the packaging validation need to be re-done? Because this is technically a different product in the same package, does it need to be re-validated or because of the similarity and the same packaging will the old validation be sufficient?
 
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BradM

Staff member
Admin
#2
Hello, and welcome to the Cove!:bigwave:

Hello, I'm new to the quality system work and have been asked to take over a lot of the package validation work, so maybe someone can help me out with this question. We have a device for which the packaging validation work has already been completed. It is a multi-layer wound care device. We added another layer to it to make a new product and we will be packaging the new product in the same packaging (poly/poly pouch). At what point does the packaging validation need to be re-done? Because this is technically a different product in the same package, does it need to be re-validated or because of the similarity and the same packaging will the old validation be sufficient?
Just because my mind works slow:lol:, let's set some variables:
A= Original product
B=Original Package- multi layers
C= New product

Before, A went into B. Now, C is going into B. Correct?

Is this a sterile product, and thus sterile packaging? How is it sterilized?
 
G

gholland

#3
I think he's not changing the package but adding another layer of something to his wound care product.

If it is a significant change in mass then you would want to re-run the packaging test as you are changing the results of the vibration and shock testing. I am not talking on a per-piece basis here but on the total mass of the package. If you are adding something that could abrade the plastic package and cause a hole during vibration testing you would need to re-test. If the dimensions on your product have changed you would need to re-test.

Is the product stacked the same way in your package? If you've changed anything about the packaging configuration you would need to re-test in my opinion.

:2cents:
 
M

MIREGMGR

#4
When the same packaging system will be used for a multiplicity of products, you do the validation for the family of products by establishing a Process Challenge Device, i.e. the worst-case of the products for which that packaging solution will be used. That worst case might be in regard to mass, volume, odd shape that stresses the materials across a bondline, or other parameters...as long as you can document a technically comprehensive analysis of why you have identified the worst case.

If the packaging is validated for the worst case product, it is validated for all less-challenging products as well.

If a single worst case product cannot be identified because several products are differently "worst case" in regard to different parameters, you might have to perform some of the validation work in multiple instances.

As gholland says above, if in your two-product family the new product is significantly different and must be considered the worst case, you'll need to validate the packaging over again, with that product as the challenge.
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#5
Leverage your risk management activity to determine if new design concerns are raised by the new configuration. As our peers have offered, by validating the super-set, you may have the rationale to support a 'no' decision to re-validation. This is harder to establish when the super-set becomes a sub-set as in your situation. However, this does not in itself mean that a re-validation is required. By reperforming the risk management activities you may establish the appropriate mitigating rationale, especially for minor configuration changes.

Establish the plan that explains your approach to validation detailing the strategy you plan to leverage. You might end up having to run a few protocols as opposed to having to rerun the entire suite of validation protocols. Create a sound summary of your validation effort (or why one wasn't needed) to establish your regulatory footing.

Regards,

Kevin
 
B

Biobry

#6
Wow, thank you all very much for your fast responses. It sounds like we will need to re-do the validation. Bot Product A and C are folded several times and then placed into the poly pouch. The extra layer added to the product to make product C does add thickness to the final package (which is gamma sterilized). It seems like this extra thickness inside the same packaging and in the same packaging configuration would make the new device, C, the "worst case", needing re-validation. I think we'll have to look into it just a little more first. If the difference in the average thickness between Product A and C is negligible then we could do a risk assessment and make the case that the validation could apply. If the difference in thickness is enough we would re-validate.

Thanks again for the suggestions.
 
S

s.parakos

#7
Does the extra thickness of the new product actually place extra stress on the packaging and in particular the seals? That would be my main area to investigate.

Simon
 
J

Jimmy the Brit

#8
Wow, thank you all very much for your fast responses. It sounds like we will need to re-do the validation. Bot Product A and C are folded several times and then placed into the poly pouch. The extra layer added to the product to make product C does add thickness to the final package (which is gamma sterilized). It seems like this extra thickness inside the same packaging and in the same packaging configuration would make the new device, C, the "worst case", needing re-validation. I think we'll have to look into it just a little more first. If the difference in the average thickness between Product A and C is negligible then we could do a risk assessment and make the case that the validation could apply. If the difference in thickness is enough we would re-validate.
Sorry to join this so late, but you also need to consider the product bioburden changes as this is a terminally sterilized product. Sometimes dressings and films can have a high bioburden due to inherent static charge /Van de Waals forces: this should be estimated and taken into account in your sterility assurance calculations, as must any change to the standard microflora and its resistance to the sterilization process, if the extra layer is a different material, or from a different supplier.

Neither of these are critical deficiencies, but a picky auditor could challenge your sterility assurance and that is never a pleasant experience.

Regards,

Jimmy
 
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