This might be a trick question. Depending on its end use, sometimes labware doesn’t need to be sterilized. It needs to be bioreduced.
What is bioreduction?
Bioreduction is a general term for reducing the number of microorganisms, or bioburden, in a product, sometimes referred to by the layman as “killing bugs.” Sterilization is a special case of bioreduction that has specific requirements set by a regulatory body, such as the FDA.
Generally, the bioreduction process is used instead of sterilization when product does not need to be labeled as sterile, such as with labware, cosmetics, pet food, and Class 1 medical devices like bandages and dental floss, to name a few.
What do I need to do to qualify my product for bioreduction?
With E-BEAM Services, the process to qualify product for bioreduction processing on our accelerators is actually almost the same as the sterilization validation.
Step 1: We perform a material test to determine material compatibility with e-beam and establish the maximum dose the product can see during production.
Step 2: We perform a dose map on a case of product as we would see it during production to determine the penetration of the electrons through the entire case of product. We use this information to determine the surface dose needed for routine production.
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If you’re not sure if your labware needs bioreduction or sterilization, reach out to our Technical Services reps at ebeam@ebeamservices.com and they’ll point you in the right direction!
