DuPont plans Engineering Changes for Tyvek 1073B & 1059B - 2011

B

bogart

#1
This is a BIG deal, but it appears that DuPont is doing everything they can to assure the transition will be painless for its customers and those downstream. They are working directly with FDA, already garnering their approval for a transition protocol. Based on DuPont and FDA statements, if DuPont's testing goes according to plan, a device manufacturer who currently uses 1073B or 1059B Tyvek will not need to submit a 510(k) or PMA for the change with respect to their device. FDA implies, and DuPont promotes, that medical device manufacturers will only need to put a note to file in their DMR indicating they are using the new equivalent 1073B or 1059B Tyvek in place of the previous 1073B or 1059B. DuPont indicates that the "1073B" and "1059B" style designations will not change, and the revised products will be functionally equivalent to the original versions.

DuPont is posting information to this website as the project progresses: medicalpackaging.dupont.com . Information is currently found using a link found under the title, "DuPont™ Tyvek® in 2012 and Beyond."
 
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R

rohinibh

#2
Re: DuPont plans Engineering Changes for Tyvek 1073B & 1059B

Well my company is taking the change pretty aggressively too. We are thinking of doing a similar control + transition tests comparison. Although still considering if we should perform shelf life testing or can we leverage it off of Dupont's data.
 
T

theGrod

#3
We are involved with the Tyvek transition. We use a tyvek pouch for a number of our products. I am being tasked with doing a risk assessment and this has always been an engineering function and not a Quality Systems function I have no idea what I am doing. Any help??:confused:
 
M

MIREGMGR

#4
If it's a task performed by your Engineering people, there must be a procedure. Have you studied that, and the relevant standard ISO 14971, and some risk files that Engineering has done?

In particular, if you do sterile barrier packaging, there probably is a risk file for the sterile barrier packaging process and materials you historically have used.

The risks of the transition are that something will change adversely in your existing processes (probably most of which are validated) and resulting performance.
 
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