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November 15, 2013 (Vol. 33 , No. 20)

Pyrogen-Free Disposable Vials

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ATMI LifeSciences

Pyrofree® vials for biopharmaceutical filling and final packaging applications are prepared by means of a depyrogenation/sterilization process that includes washing and heating. After the vials are subjected to high temperatures in a polyether ether ketone (PEEK) bag, they are double-vacuum-packed in a PEEK bag for tamper evidence, as well as to maintain sterility and guarantee no external contact. A third PE/PA layer, a polyethylene/polyamide film, is added to the packaging under vacuum in a class C cleanroom to protect the vials from breakage during transportation and to lessen the need for a support tray.

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