Silicone Lubricant Grade - Requirements for Condom Production

N

nurhakim

#1
Hi Coves,

Are there any specific requirement for silicone lubricant used in condom production, does it has to be a medical grade?

Thanks
 
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M

MIREGMGR

#2
Condoms are devices. A lubricant is a component. This lubricant has human mucous membrane production, at least. At a minimum, the lubricant material would have to be biocompatibility qualified and no-chemical-change controlled.

Typically in my experience, manufacturers are not eager to provide the latter control on industrial grade materials, but your experience might be different.
 
N

nurhakim

#3
Condoms are devices. A lubricant is a component. This lubricant has human mucous membrane production, at least. At a minimum, the lubricant material would have to be biocompatibility qualified and no-chemical-change controlled.

Typically in my experience, manufacturers are not eager to provide the latter control on industrial grade materials, but your experience might be different.
Hello,

Thanks. In this case the supplier is not able to provide the biocompatibility report. So we do not have any basis that the silicone is biocompatible or not.
 
M

MIREGMGR

#4
You can have testing done on a particular production sample, but you must have a significant basis for knowing that the production process within a batch is uniform so that the testing results apply to the whole batch from which the test sample was drawn, and that the production process between batches is uniform so that the testing results continue to apply.

All that "medical grade" means is that the supplier has committed themselves technically and legally to maintaining such continuing product uniformity along with the necessary supportive technical characteristics such as process cleanliness, thoroughly controlled suppliers and sub-suppliers, and careful ingredient and process handling.
 
M

MIREGMGR

#5
Heh. It's funny how you can think one word and type another. I get a lot of interruptions in my office, so maybe that's my excuse...or maybe it's brain fade. Or maybe I was mentally working on two problems at once. Whatever.

In the second post of the thread, I said "production" and meant "contact". Odd.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Heh. It's funny how you can think one word and type another. I get a lot of interruptions in my office, so maybe that's my excuse...or maybe it's brain fade. Or maybe I was mentally working on two problems at once. Whatever.

In the second post of the thread, I said "production" and meant "contact". Odd.
It happens to us all, once in a while...
 
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