Patent ID: 9327079
Filing Date: 2016-05-03
CPC Classification: A61M,G01N

Claim Text:
1. A quality control method for determining a lubricant coverage at the inside surface of a syringe barrel for a pre-filled and post-filled syringe barrel, wherein the pre-filled syringe barrel is defined as prior/pre to a time of filling of the syringe barrel with an aqueous-based solution, and wherein the post-filled syringe barrel is defined as after/post a time of the filling of the syringe barrel with an aqueous-based solution, comprising: for the pre-filled syringe barrel: (a) providing a pre-filled syringe barrel having an inner surface, wherein the inner surface has not yet been covered with a lubricant; (b) applying a lubricant to cover to the inner surface of the pre-filled syringe barrel using a lubricant covering device, therewith creating a lubricant-covered pre-filled syringe barrel; (c) prior to filling the lubricant-covered pre-filled syringe barrel with an aqueous-based solution, obtaining one or more pre-fill optical properties of the lubricant-covered barrel, wherein the one or more pre-fill optical properties are obtained at a time T (d) determining a pre-fill quality measure for the lubricant-covered pre-filled syringe barrel using the one or more pre-fill optical properties as input to a computer-implemented pre-fill barrel quality measure determination program executed on a first computer, wherein the pre-fill quality measure is used by a first syringe processing system to reject or accept the lubricant-covered pre-filled syringe barrel based on a predetermined pre-fill quality threshold; and for the post-filled syringe barrel: (e) providing a pre-filled lubricant-covered syringe barrel, wherein the pre-filled lubricant-covered syringe barrel has not yet been filled with the aqueous-based solution; (f) filling the pre-filled lubricant-covered syringe barrel with an aqueous-based solution using an aqueous-based solution filling device, therewith creating a lubricant-covered post-filled syringe barrel; (g) obtaining one or more post-fill optical properties of the lubricant-covered post-filled syringe barrel, wherein the one or more post-fill optical properties are obtained at a time T (h) determining a post-fill quality measure for the lubricant-covered post-filled syringe barrel using the one or more post-fill optical properties as input to a computer-implemented post-fill barrel quality measure determination program executed on the first computer or a second computer, wherein the post-fill quality measure is used by the first syringe processing system or a second syringe processing system to reject or accept the post-filled lubricant-covered barrel based on a predetermined post-fill quality threshold.