Syringe barrel lubricant coverage quality control

摘要

A quality control method or system for determining a lubricant coverage at the inside surface of a syringe barrel is provided. The timing for the quality control is not intuitive, yet crucial for patient's safety. The pre-fill test is for a pre-filled (empty or no drug solution), yet oil lubricated, barrel. This pre-fill test needs to be performed within a certain time window immediately following the lubrication. The post-fill test is for a post-filled oil lubricated syringe barrel filled with a solution. This post-fill test needs to be performed after a certain time window has passed from the filling with the solution. The quality control methods could lead to a reduction of health-risks or avoid life-threatening situations associated with syringes that are either below or above the desired lubrication coverage.

主权项

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 Te defined as
Te,0Tf≧Tf,1,whereinTf,1=8.8 exp(0.0063η)defined in minutes and defined from Tf,0, where η is the viscosity of the applied lubricant and defined in cSt, wherein Tf,0 is the time of the filling the aqueous-based solution, and wherein the one or more post-fill optical properties are obtained using the first imaging system or a second imaging system; and (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.