Parenterals Vial Manufacturing Filling Area Yield Improvement Project

Abstract

In the Parenterals Pharmaceutical industry a quality, financial and manufacturing measure of how the process is being operated and that measures the appropriate use of materials, excipients, and active product ingredients is the Yield. The Yield on a Parenterals vial manufacturing filling area equals to a percentage between the amount of formulated product versus the calculated amount of product filled by using the quantity of vials and the filled weight. Some of the frequent factors contributing to product loss in the filling process are product filtration losses, rejected vials and filling weight variations. A reduction of yield result in financial costs, can led to quality events or investigations, and have an impact on the efficiency of the process. The vial filling process for a Parenterals manufacturing pharmaceutical has a yield for a Lyophilized product of 96.6% which is considered high when compared to a similar area filling the same product of 98%. To look into the factors and establish a strategy to increase the yield at this area, this project was developed under the Lean Six Sigma principles and using DMAIC systematic five-step approach, in order to identify major factors influencing the yield reduction to enable the company to reduce unnecessary costs, gain efficiencies, as well as supplying high quality product to the patients. Key Terms - DMAIC, Financial Costs, Lean Six Sigma, Product Loss, Quality Events, Yield.