Packaging Validation - New Machinery - Terminally Sterilized Medical Devices

T

ttuyoc

#1
Hello All,

I work for a medical device manufacturer that manufactures terminally sterilized medical devices.

We are in the process of moving to another facility and one of our tray sealing machines is currrently validated following the ISO 11607-2 standards. (IQ,OQ,PQ protociols)

We are going to purchase 2 similar machines that are going to be sealing the same type of tray to the same tyvek lid as our current machine does. Will the new machines require a full validation or is there a way we can perform solely a PQ, since we have our critical parameters set for the current machine?

Any thoughts?
 
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Stijloor

Staff member
Super Moderator
#2
Hello All,

I work for a medical device manufacturer that manufactures terminally sterilized medical devices.

We are in the process of moving to another facility and one of our tray sealing machines is currently validated following the ISO 11607-2 standards. (IQ,OQ,PQ protocols)

We are going to purchase 2 similar machines that are going to be sealing the same type of tray to the same tyvek lid as our current machine does. Will the new machines require a full validation or is there a way we can perform solely a PQ, since we have our critical parameters set for the current machine?

Any thoughts?
Can someone help our Member?

Thank you very much.

Stijloor.
 

somashekar

Staff member
Super Moderator
#3
Hello All,

I work for a medical device manufacturer that manufactures terminally sterilized medical devices.

We are in the process of moving to another facility and one of our tray sealing machines is currrently validated following the ISO 11607-2 standards. (IQ,OQ,PQ protociols)

We are going to purchase 2 similar machines that are going to be sealing the same type of tray to the same tyvek lid as our current machine does. Will the new machines require a full validation or is there a way we can perform solely a PQ, since we have our critical parameters set for the current machine?

Any thoughts?
New machines ..so will need fresh IQ for each of them.
OQ to ensure that your critical parameters without any change still reproduces the same result on both the new machines. Learning from the previous validation is applied here to ensure that same are still effective, (or minor changes made to get required results).
If any changes are indeed made though minor, then a PQ will show continued optimum performance.
Sterilization being a critical process the sealing integrity is top priority and I would say complete validation, taking all the learnings from the first done validation.
 
M

MIREGMGR

#4
I mostly agree with Somashekar, except that I'd think if the two new machines are identical models with identical options and setups to be used for an identical task with identical materials in an identical environment, then perhaps only one of them will need a full IQ/OQ/PQ, with the other one needing only a verification of identical performance with an identical setup.
 

Ajit Basrur

Staff member
Admin
#5
MIREGMGR is right.

As per GHTF, Process Validation Guideline, sec 6.4

The need for revalidation should be evaluated and documented. This evaluation should include historical results from quality indicators, product changes, process changes, changes in external requirements (regulations or standards) and other such circumstances.

Revalidation may not be as extensive as the initial validation if the situation does not require that all aspects of the original validation be repeated. If a new piece of equipment is purchased for a validated process, obviously the IQ portion of the validation needs to be repeated. However, most of the OQ aspects are already established. Some elements of PQ may need to be repeated, depending on the impact of the new equipment.

PS : Welcome to the Cove, ttuyoc :agree1:
 
M

MIREGMGR

#6
By the way...the existing machine will need to have its validation verified as well, since the de- and re-installation of the machine itself, the physically different-location environment, and the new set of supporting utilities etc. may affect the IQ, per 5.2.
 
J

Juan Dude

#8
New machines ..so will need fresh IQ for each of them.
OQ to ensure that your critical parameters without any change still reproduces the same result on both the new machines. Learning from the previous validation is applied here to ensure that same are still effective, (or minor changes made to get required results).
If any changes are indeed made though minor, then a PQ will show continued optimum performance.
Sterilization being a critical process the sealing integrity is top priority and I would say complete validation, taking all the learnings from the first done validation.
Since sterilization is a critical process I would go with this advice. :2cents:
 
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