Shelf Life Validation for new Heat Impulse Medical Packaging Sealer

J

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.
 

Stijloor

Leader
Super Moderator
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.

Can someone with medical packaging expertise help?

Thank you.

Stijloor.
 

bio_subbu

Super Moderator
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.

When you install a new packing machine, you needs to do a validation includes of installation and operational qualifications of equipment. The critical parameters for impulse sealers to achieve a proper seal are temperature, pressure, and dwell time. Then only impulse sealer that can help users comply with ISO 11607 and EN 868-5 requirements for packaging processes, validation, and process control. Since your new machine having the digital temperature control, you must validate in different temperatures and sterilize the product with EO and do the sterility test.

As regards to tensile strength, the ISO 11607 and EN 868-5 stipulate that a package’s seam strength before and after sterilization be at least 1.5 N for a 15- mm-wide strip. This can be determined by means of a tensile-strength test. My suggestion is to do aging studies also, will check with others feedback.
 
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