Patent ID: 6398771
Filing Date: 2002-06-04
Classification: A61J,A61M,B32B,B65D

Abstract:
A method of preparing a flexible transparent container for improved storage of oxygen sensitive parenterally administerable agents wherein the container comprises an inner, primary container enclosed in a substantially oxygen impermeable outer envelope with an oxygen absorber, capable of consuming essentially all residual oxygen after the outer envelope is sealed, as well as the oxygen penetrating said envelope wherein:(i) the inner container is made of a polypropylene containing flexible polymeric material compatible with lipophilic agents capable of forming both permanent and peelable seals; (ii) the envelope is made of a substantially water impermeable flexible multilayered polymeric material comprising: a) a first outer substantially water impermeable polymeric film with oxygen barrier forming capacity, assembled with b) a second, inner polymeric film with a supplementary oxygen barrier forming capacity; and in that the container essentially maintains its characteristics after being subjected to sterilization by steam or radiations,the method of preparing comprising the steps of: a) introducing a flexible polymeric multilayered material and forming a bag shaped sealed inner container by welding together its polypropylene containing sealing layers and optionally forming at least two chambers by forming at least one partitioning peelable seal seam; b) providing a side of said inner container with at least one temporary opening; c) filling the inner container with at least one parenterally administerable fluid through said temporary opening; d) sealing the temporary opening at the side of said inner container by welding permanent seams; e) enclosing the filled and sealed container in an oxygen barrier forming envelope together with an oxygen absorber; and f) sealing the envelope by means of welding and finally, sterilizing the container.