Syringe Barrel Lubricant Coverage Quality Control

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,0<Te≦Te,1
• wherein Te,0 is the time of the applying the lubricant, wherein
• Te,1=0.05η
• defined in minutes, wherein η is a viscosity of the applied lubricant and defined in cSt, and wherein the one or more pre-fill optical properties are obtain using a first imaging system;
• (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 Tf defined as
• Tf≧Tf,1,
• wherein
• Tf,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.