Hello,
My company is working to determine the correct dunnage to use in our upcoming ethylene oxide sterilization validation. Our worst-case product consists of 18ft of dual bore PVC tubing packaged in Tyvek pouches inside a cardboard box. We are unable to use the exact tubing for the dunnage as it would be impossible to get the high quantities needed in such short notice. Can anyone give any tips for how to determine an acceptable dunnage product? Does it have to be the exact compound of PVC? How close in weight/overall load density do the calculations need to be? The standard is very vague and I don't want to do it incorrectly.
Additionally, if a company is not able to complete their annual re-qualification of their sterilization process within the allotted time, what are they supposed to do? Are they supposed to stop sterilizing product until the re-qualification is complete?
Appreciate any insight you can give me!!
My company is working to determine the correct dunnage to use in our upcoming ethylene oxide sterilization validation. Our worst-case product consists of 18ft of dual bore PVC tubing packaged in Tyvek pouches inside a cardboard box. We are unable to use the exact tubing for the dunnage as it would be impossible to get the high quantities needed in such short notice. Can anyone give any tips for how to determine an acceptable dunnage product? Does it have to be the exact compound of PVC? How close in weight/overall load density do the calculations need to be? The standard is very vague and I don't want to do it incorrectly.
Additionally, if a company is not able to complete their annual re-qualification of their sterilization process within the allotted time, what are they supposed to do? Are they supposed to stop sterilizing product until the re-qualification is complete?
Appreciate any insight you can give me!!
