Understanding USP <1112> Water Activity as applicable to Medical Devices

[tll120]

Hi - I'm seeking information regarding FDA's perception/acceptance of the use of USP <1112> APPLICATION OF WATER ACTIVITY DETERMINATION TO NONSTERILE PHARMACEUTICAL PRODUCTS to determine bactericidal properties of a medical device?

If anyone can offer guidance, please share. Thank you.

 

[Ronen E]

Hi - I'm seeking information regarding FDA's perception/acceptance of the use of USP <1112> APPLICATION OF WATER ACTIVITY DETERMINATION TO NONSTERILE PHARMACEUTICAL PRODUCTS to determine bactericidal properties of a medical device?

If anyone can offer guidance, please share. Thank you.

Hello and welcome to the Cove

Are you dealing with a Medical Device or with a Pharmaceutical (per FDA definitions)?

Medical Devices usually don't rely on the USP in the context of determining biological loads. There are other standards.

Cheers,
Ronen.

 

[tll120]

Hi Ronen,

Thanks for your response! We are dealing with a medical device with inherent bactercidal properties. We are trying to substantiate a "bactericidal" labeling claim by demonstrating the MOA to be desiccation and referencing aw levels of several organisms presented in USP <1112>.

 

[Ronen E]

Hi,

It sounds like a very specific question. I would recommend contacting your FDA reviewer and trying to get a direct, authoritative answer.

Cheers,
Ronen.

 

[tll120]

Thanks again, Ronen!