Ethylene Oxide Sterilization Validation-Reference Load

E

erj526

#1
Hello! My company is about to run an EtO sterilization validation on medical devices. We were told that our reference load, or dunnage load, needed to be filled with all products that represent the worst case load and that these products will be scrap. For a small company like us, this is just not possible to have that many products (800 something products) going to waste.

Does anyone know if the reference load needs to actually consist of the same product? Can it just be boxes of the same filled with something else like packing peanuts or something? Is there any possible way around this?

Any help with this is greatly appreciated!
 
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Rincewind

Involved In Discussions
#2
Hello,

you should perform a documented worst case evaluation of your products and run the validation with those worst case products. Only by doing this you can claim that the chosen sterilization method is able to provide a sterile product.

You don't necessarily have to this with all 800 products of yours, only with the ones you deemed to be the most difficult to sterilize (the worst case products).
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#3
What Rince said. Give them samples of your highest burden products to make a worst case example. There is a lot of upfront cost in this but once established you can paper adopt new products. Try to have the validation cover a "family" of products where you can (Similar products grouped together)
 
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