Sterile Product or Not Sterile - The device has "Gamma Irradiated" printed on it

W

willswolf

#1
I thought I seen this asked before but now I can't find it anymore so I will just ask again.

"exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile."

If the label on the device has "Gamma Irradiated" printed on it is that representing sterile? And how about for MDD? Would that also constitute that the device is sterile?
 
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S

SilkTie

#3
I thought I seen this asked before but now I can't find it anymore so I will just ask again.

"exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile."

If the label on the device has "Gamma Irradiated" printed on it is that representing sterile? And how about for MDD? Would that also constitute that the device is sterile?
Gamma irradiation is a sterilisation method and anyone in the market will understand from this marking that it is sterile.

So my answer would be: yes, unless you remove the packaging and use it in your own, non-sterile device.
 

pkost

Trusted Information Resource
#4
If the device is sterile, then ER 13.3 of the MDD states:

The label must bear the following particulars:
(c) where appropriate, the word ‘STERILE’;
therefore if you are an end user you should not consider a "gamma irradiated" label as sterile, and if you are a manufacturer unless you have a good justification, you are in breach of the regulations
 
D

Denis

#5
You have to justify the use of the word "Sterile" on your packaging.

Just because a product is gamma irradiated - it does not mean it is sterile.

There are three main types of test to confirm sterility (10 -6).

Method 1
Method 2
VD Max study.

each has its own merits - but don't assume that a gamma irradiation product is sterile.

Bioburden type and count are very important.
 
M

MIREGMGR

#6
I'd be concerned if, as seems to be described, the "gamma irradiated" language is an attempted end-run around the clear intent of the FDA classification rule. If that's the case, I think it's likely that if it came to their attention, the FDA would determine that the device is misbranded due to misleading labeling.

I agree with above posters that this language does not mean the device is sterile, though users might interpret it in that manner.
 
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