Dear Karen: How many samples do I need for an e-beam material test?

 

Dear Karen,

I am a new startup company, and am trying to get my product validated for e-beam sterilization. How many samples do I need to send you for the material test? And, while we’re talking about material tests….what are they?

Sincerely,

Material Girl

 

Dear Material Girl,

This is a great question, as most of our customers have to perform a material test early on in the product development process.

A material test may have slightly different goals, depending on your product. For sterilization customers, a material test is part of the sterilization validation process that helps determine the maximum dose your product can receive before there is any degradation. For polymer modification customers, a material test may be trying to determine the dose your product needs for effective crosslinking. In essence, though, the main purpose of a material test is the same: to determine how e-beam works with your product.

Now let’s talk about quantity. The number of samples you send for a material test is actually completely up to you! Or, rather, the number of samples your lab will need to perform efficacy testing afterwards.

Typically, a material test with E-BEAM consists of two or three doses (which our friendly Technical Services team can recommend if you have no clue where to start!). For example, if you had a new controlled substance pellet you wanted to find the maximum dose for, one of our Technical Services reps would probably recommend running samples at 50 kGy and 60 kGy. The number of samples per dose depends on how many samples your lab needs to perform the subsequent testing. If your lab says you need 10 pellets to perform the testing, then you would send us 10 samples per dose, for a total of 20 pellets.

If you want to learn more about material tests and how they relate to your product, contact our Technical Services team.

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