Method of packaging and sterilizing a pharmaceutical product

Claim 1

A method of preparing and sterilizing a pharmaceutical package comprising a semi-rigid, squeeze-type bottle containing a selected pharmaceutical liquid product; said method including the steps of: (a) preparing, in a predetermined period of time prior to the filling operation, a plurality of bottles formed of a material compatible with the product to be contained therein, by application of a self-adhesive label having a width sufficient to extend a prescribed distance around the circumference of said bottle; said label being made from a prescribed material and having the required identifying indicia printed thereon; (b) preparing a cap for each of said bottles by inserting an appropriately sized washer into the top of said cap; said washer being formed of a non-toxic expandable material and serving to absorb expansion of said bottle and cap during subsequent sterilization and to eliminate leakage therefrom; (c) filling the individual bottles with the selectable pharmaceutical product, ensuring that each bottle is filled to capacity and eliminating residual air in the bottle of bottle neck; (d) inserting a plug-type adapter into the neck of each bottle, forcing out excess liquid; said adapter being of the type used for connecting the pharmaceutical package to a cannula or other such medical apparatus; (e) placing one of said prepared caps with said washer therein on each of said bottles and tightening by prescribed means; (f) forming a package by inserting each of said bottles into an individual blister pack formed of a prescribed polymeric material suitable for use in a steam sterilization procedure; and sealing each of said blister packs along the open side thereof with a closure lid made from a non-woven material having the characteristics of being fluid permeable and capable of withstanding and remaining sealed during a steamsterilization procedure; (g) placing each of said packages blister-side-up in sterilizing trays formed of a wire mesh material, removing the supported weight of the enclosed bottle from the blister; (h) sterilizing said package using an over-pressure steam-sterilizing technique, at a prescribed temperature and pressure; and (i) removing said packages to a drying room and allowing to dry before inspecting and preparing for shipping.

Claim 2

A method of preparing and sterilizing a pharmaceutical package comprising a semi-rigid, squeeze-type bottle containing a selected pharmaceutical liquid product; said method including the steps of: (a) preparing, in a predetermined period of time prior to the filling operation, a plurality of bottles formed of a material compatible with the product to be contained therein, by application of a self-adhesive label having a width sufficient to extend a prescribed distance around the circumference of said bottle; said label being made from a prescribed material and having the required identifying indicia printed thereon; (b) preparing a cap for each of said bottles by inserting an appropriately sized washer into the top of said cap; said washer being formed of a non-toxic expandable material and serving to absorb expansion of said bottle and cap during subsequent sterilization and to eliminate leakage therefrom; (c) filling the individual bottles with the selectable pharmaceutical product, ensuring that each bottle is filled to capacity and eliminating residual air in the bottle of bottle neck; (d) inserting a plug-type adapter into the neck of each bottle, forcing out excess liquid; said adapter being of the type used for connecting the pharmaceutical package to a cannula or other such medical apparatus; (e) placing one of said prepared caps with said washer therein on each of said bottles and tightening by prescribed means; (f) forming a package by inserting each of said bottles into an individual blister pack formed of a prescribed polymeric material suitable for use in a steam sterilization procedure; and sealing each of said blister packs along the open side thereof with a closure lid made from a non-woven material having the characteristics of being fluid permeable and capable of withstanding and remaining sealed during a steamsterilization procedure; (g) placing each of said packages blister-side-up in sterilizing trays formed of a wire mesh material, removing the supported weight of the enclosed bottle from the blister; (h) sterilizing said package using an over-pressure steam-sterilizing technique, at a prescribed temperature and pressure; and (i) removing said packages to a drying room and allowing to dry before inspecting and preparing for shipping.