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

T

tll120

#1
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.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
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 :bigwave:

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.
 
T

tll120

#3
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

Problem Solver
Staff member
Moderator
#4
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.
 
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