Filling Line Improvements to avoid the Defect of Product on the Stopper for Sterile Syringes

Abstract

This research aims to optimize the syringes filling line at the facility to not exceed the action limits because of the defect of syringes with product on the stopper. The product or liquid on the stopper of the syringe is one of the defects that can be encountered in sterile solutions for subcutaneous administration. This defect is classified as major, and the established control limit is not more than (NMT) 1.0%. The project implementation will reduce the defect of syringes with product on the stopper to ensure the manufacturing of the product according to the quality standards and lowest customer risk. Futhermore, will reduce re-inspection lots, the product cost, and Quality Events. Key Terms -- Product on the stopper, Sterile solutions, Sterile solutions filling line, syringe defect.