Process Improvement and Cost Reduction Opportunities by a Change in the Packaging Material of Human Thrombin Component Coming in Vials

Abstract

Human Thrombin is a bleeding control agent that is formulated, filled into a glass vial, and lyophilized to maintain stability. In order to be shipped, the vials are packaged in a container made from cardboard material. Particulate matter coming from the packaging is transferred to the vials which results in the addition of a cleaning step prior to subsequent processing. An alternate plastic packaging material consisting of Polyethylene Terephthalate and Polypropylene was evaluated. Assessment of the cleaning process showed that a change in the current packaging represents an improvement in terms of the elimination of a non-value- added step and the associated labor cost. Additional evaluation demonstrates that this change also implies a reduction in scrap and in the costs applied for shipping. By identifying and implementing an alternate packaging material, product quality is improved, and non-value-added process steps and associated costs are eliminated, which will result in costs savings. Key Terms ⎯ Cleaning Process, Cost Reduction, Packaging Container, Particle Matter