Dear Karen,
I have qualified my product for sterilization at a gamma facility, but am interested in transitioning to electron beam. I already know what dose my product needs for gamma sterilization. Is this dose going to be the same for e-beam sterilization?
Sincerely,
Max Dose (Name changed for privacy. And because I’m a sucker for puns.)
Hi Max,
Thank you for your question.
For medical device sterilization, there are two different kinds of doses to keep in mind: the minimum dose, and the maximum dose.
The minimum dose is the dose needed in order to destroy a certain percentage of colony forming units (CFUs) on your product, and thus have your product considered sterile. Or, in layman’s terms, the amount of dose necessary to annihilate all the bugs on your product. Think microbial doomsday.
The maximum dose is the amount of dose your product can see before you start to see some adverse effects, such as degradation or discoloration. We want your product to be sterile AND still be able to function without falling to pieces.
Because the minimum dose has more to do with your specific product, manufacturing procedures, and facility, it will be the same for both forms of radiation sterilization: gamma and electron beam.
Your maximum dose, however, may be higher for e-beam than gamma, as e-beam has a faster dose rate. This means your product is exposed to the radiation source for a much shorter time during electron beam sterilization, leading to less material degradation, especially for sensitive plastics like polypropylene. In other words, less exposure = less degradation.
So, are you ready to set up a material test with us to determine your maximum dose? Then give us a call at 513-933-0031, or shoot us an email at ebeam@ebeamservices.com!
