PACKAGE SYSTEM FOR STERILIZING AND STORING CYANOACRYLATE ADHESIVE COMPOSITIONS

摘要

Package systems that provide for prolonged shelf stability of sterilized cyanoacrylate compositions are provided. The package systems include an ampoule made from a material that is substantially impervious to gas and moisture penetration that includes a frangible foil seal, and an overpack. The ampoule contains a stabilized cyanoacrylate monomer composition, and may be sterilized by irradiation without substantially altering the viscosity of the composition. The package may be sterilized by ethylene oxide without substantially further altering the viscosity of the composition. The sterilized composition, when contained within the package system, is shelf-stable for a period of at least 24 months.

主权项

1. A twice-sterilized package system including a stabilized cyanoacrylate monomer composition, the package system comprising:
an ampoule having sidewalls comprised of a material that is substantially impermeable to gas and substantially impermeable to moisture, which sidewalls surround a chamber containing a stabilized cyanoacrylate monomer composition comprising an amount of a free radical polymerization inhibitor and an anionic polymerization inhibitor effective to stabilize the cyanoacrylate monomer, and optionally, a polymerization accelerator mixed together with the cyanoacrylate monomer, which chamber comprises an opening that is sealed with a foil seal comprising a plurality of layers, wherein the ampoule containing the stabilized cyanoacrylate monomer composition has been sterilized by irradiation, thereby producing an ampoule containing a sterilized, stabilized cyanoacrylate monomer composition, and the sterilized, stabilized composition has a viscosity of about 3 cPs to about 12 cPs; and an overpack, which is substantially permeable to gas, having a front wrapper and a back wrapper that are sealed together around the ampoule thereby housing the ampoule containing the sterilized, stabilized cyanoacrylate monomer composition, wherein the overpack housing the ampoule containing the sterilized, stabilized cyanoacrylate monomer composition has been sterilized by chemical sterilization, thereby producing the twice-sterilized package system including the sterilized, stabilized cyanoacrylate monomer composition having a viscosity of about 3 cPs to about 12 cPs; wherein the twice-sterilized package system containing the sterilized, stabilized cyanoacrylate monomer composition, when stored in the package system for at least about two years, has a viscosity of less than about 50 cPs.