Risk Prevention in Syringe Filling Line in a Pharmaceutical Manufacturing Plant

Abstract

Risk prevention in syringe filling line can be achieved through the implementation of “Defense in Depth” concepts. Defense in Depth is based on the integration of 3-layers of operational controls which are Equipment, Procedure, and Well-Trained Staff. This project will be conducted through all stages of a syringe filling process area in a pharmaceutical company. The objective of this project is to mitigate critical errors and threat to operations through the establishment of the Defense in Depth and thus avoiding costly errors. This project has three main contributions which include evaluating the current state of control of Critical Process Parameters, providing an assessment of the current operational states, and lastly setting the expectation that all future modification to equipment, procedures or staff qualification should consult the methodology to ensure continuous improvement. Through Defense in Depth, this company was able to identify and strengthen vulnerable and high risk areas in a syringe filling line. Key Terms - CAP Analysis, Defense in Depth, FMEA, Risk Assessment.