Double Blister Pack for an Implantable Device

G

gfreeman

#1
Hello all
I am an engineer in a medical device company, trying to design a blister pack for our device.
The device is implanted and comes pre-loaded in a disposable delivery system.
Do I need to build a double blister packaging (the delivery system will be inside a sterile blister, closed with tyvak and this will be in another sterile blister) ?
If so what is the purpose of the double blister pack ? sa
As I read the ISO 11607 (2006) it did not mention any of this subject

thank you.
 
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pkost

Trusted Information Resource
#2
There is no requirement per se, it is market driven. Depending on the area of implantables you work in, there is an expectation within hospitals to have double blisters/pouches.

The benefit is a reduction in risk - it means that the implant does not have to be opened outside of the sterile field - the outer blister is opened by non sterile staff and the inner blister dropped into the sterile field; the inner blister can then be opened by the "sterile" scrub nurse.
 
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