Importance

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Abstract

A sealed, empty pouch, wherein the interior of the pouch is particle and pyrogen free, is made by (i) molding a tubular film including an inner surface and an outer surface, and blowing or otherwise directing micro-filtered air and/or other gas through the tubular film during molding; (ii) flattening the molded tubular film; (iii) sealing the flattened tubular film at spaced locations, cutting the sealed film at the spaced locations, and forming a plurality of empty pouches; (iv) over-molding a fitment to the outer surface of each of a plurality of empty pouches and forming a fluid-tight seal between the fitment and the interior of the pouch; and (v) preventing the collection of particles on the inner surface of each pouch, and the exposure of each such inner surface to an ambient atmosphere throughout steps (i) through (iv).

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First Claim