So first, uh, before we get there, Martel, maybe you can explain, you know, the regulatory guidance for sterility testing, what it is, what, you know, what, what the, uh, agencies put out there.

Yeah.

So when we talk about this, we have to think both, uh, both what do we t- what do we follow, what do we... how do we approach things here in the US, and then also outside the US.

So in the US, a- and this is a point of confusion that, uh, that we hope at some point we can clear up, that, that the mindset historically has been, if it's a drug product, I follow USP, if it's a medical device, I follow ISO.

Uh, because the, the, there's subtle differences in, in how we perform the sterility test with those two standards bodies.

But the, the way it really should be is USP, or specifically USP 71, really is intended for products that have been aseptically processed.

So there is no terminal sterilization process in place.

And Martel, I'm glad you brought up packaging, 'cause my next question involved, um, whether or not sterility testing was for the device, you know, the packaging, is it for both? You know, maybe you can explain more on that.