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JJLit
We are a medical device manufacturer that is putting in a new heat impulse medical packaging sealer machine. It's replacing a decade old machine that was in place long before I got here.
Our product is packaged in Tyvek pouches and can either have a 5 year or 10 year shelf life depending on the device and sterilization (EO or Gamma).
My problem is this. Do I need to validate the shelf life because of the new sealer? Am I just validating the seal integrity? We have done extensive testing for sterility in the past and have confidence of our current shelf life. I am a little confused in this area.
I want to claim equivalence to the old machine and process but that machine did not have digital controls. Temperature and pressures are just digits on a rheostat. The new machine is all digital and temperatures and pressures are easily controlled. I can't measure the temperature of the seal at all to compare one machine to the other. I briefly looked into artificial aging but was a little overwhelmed.
Thanks in advance for any help that is given.
Our product is packaged in Tyvek pouches and can either have a 5 year or 10 year shelf life depending on the device and sterilization (EO or Gamma).
My problem is this. Do I need to validate the shelf life because of the new sealer? Am I just validating the seal integrity? We have done extensive testing for sterility in the past and have confidence of our current shelf life. I am a little confused in this area.
I want to claim equivalence to the old machine and process but that machine did not have digital controls. Temperature and pressures are just digits on a rheostat. The new machine is all digital and temperatures and pressures are easily controlled. I can't measure the temperature of the seal at all to compare one machine to the other. I briefly looked into artificial aging but was a little overwhelmed.
Thanks in advance for any help that is given.