Ampac, a division of ProAmpac, has announced 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 Flexi-Free 7200, has been independently tested and proven to reduce sealant side extractables by 60 percent over solvent-based laminations. This reduction of sealant side extractables (in water, alcohol and hexane) by 60 percent 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, a low moisture transmission rate, low oxygen transmission rate and low light penetration.