E-BEAM’s latest Crash Course walks the viewer through a quick overview of the four main steps to sterilization validation.
To be able to officially declare your medical device as sterile after processing, you must first perform a sterilization validation. Radiation sterilization methods, like e-beam, are monitored by the ISO 11137 standard. But don’t worry, both your sterilization provider and microbiology lab will help walk you through it!
1.) Preliminary Assessment aka Bioburden Testing
The first step is a preliminary assessment. This is done with your microlab, and is used to determine the untreated biological load of your product–or, in layman’s terms, how many bugs need to be killed. Also called bioburden testing, this helps us determine the MINIMUM dose your product needs to be exposed to in order to be considered sterile.
2). The Material Test
The next step is called a material test. This test helps us determine if the materials that make up your product are compatible with the e-beam treatment, and is done with your sterilization provider. E-BEAM Services would take several samples of your product, and dose them to different levels before sending them back to you so you can test for degradation. This determines the MAXIMUM dose your product can see.
3.) Dose Mapping
The third step is to perform a dose map. This is also done with your sterilization provider. Essentially, dosimeters are placed throughout a case of your product in its final packaging to help us determine the dose distribution throughout the entire case. This information then helps us know how to properly dose your product so that everything stays within the min and max determined in steps 1 and 2.
4). Dose Verification
The fourth and final step is a dose verification study. Both your microlab and your sterilization provider will help with this test, where the efficacy of the min dose established in step 1 is verified. Typically this test is done on a quarterly basis.
Once the sterilization validation is complete, you won’t have to do it again (!)—unless there is a change to your product or packaging. If you are looking to switch sterilization methods (like from gamma to e-beam), then the validation does have to be redone. However, if you’re switching providers within the same sterilization method (like e-beam to e-beam), then you only have to re-do the dose map.
Have more questions? Or maybe you’re ready to start the validation process? Reach out to our Tech Services reps at email@example.com!