Submitted by: Submitted by Patrick1Gall
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Category: Business and Industry
Date Submitted: 06/09/2016 12:23 AM
Ampac Announces Low Extractable Barrier Lamination PRO FlexiPURETM
1888 PressRelease Ampac announces a new low extractable barrier lamination, PRO FlexiPURETM, which
enhances the existing family of successful barrier drug and medical device overwrap laminations for the
pharmaceutical and medical device markets.
Ampac, a division of ProAmpac, announces a new low extractable barrier lamination, PRO FlexiPURETM,
which enhances the existing family of successful barrier drug and medical device overwrap laminations for
the pharmaceutical and medical device markets.
As analytical equipment has improved, detection limits of trace contaminants have lowered. In filing new
drug applications using packaging film, these detectable trace compounds must be included in the drug
submission process, identified, risks analyzed, and monitored, all of which costs pharmaceutical companies
time and money. The fewer of these components that are realized in the film structure, the less time and
money needed to be spent on this portion of a new drug submission.
To strengthen their existing family of successful barrier drug overwrap laminations, Ampac is introducing a
low extractable barrier lamination called PRO FlexiPURE, which addresses the amount of trace
contaminants found in film structures. This product line extension to Ampac's drug overwrap films Flexi
2114, Flexi 6554/6702, and FlexiFree 7200, has been independently tested and proven to reduce sealant
side extractables by 60% over solvent based laminations. This reduction of sealant side extractables (in
water, alcohol and hexane) by 60% produces a low extractable, clean lamination profile.
The benefit of PRO FlexiPURE to the customer is a reduction in time and effort needed in completing
packaging requirements of drug submissions. With a low extractable profile, there are fewer compounds to
be identified, analyzed and monitored. In addition, the aluminum foil barrier provides excellent shelf life, ...