Interventions Risk Evaluation and Management in Aseptic Manufacturing

Abstract: Interventions performed by personnel during an aseptic process can be a key source of microbiological contamination of sterile bio-pharmaceutical products, irrespective of type of manufacturing system used. Understanding the relative risk of this source of contamination provides valuable information to help make decisions for the design, qualification, validation, operation, monitoring and evaluation of the aseptic process. These decisions can be used to improve the aseptic process and provide assurance of the sterility of the products. To achieve these goals, an assessment of the contamination risk is needed. This risk assessment should be objective, accurate, and useful. This paper presents an Intervention Risk Evaluation Model (IREM) philosophy and an objective, accurate, and useful method for intervention risk determination. The IREM uses a key word approach to identify, obtain, measure, and evaluate intervention risk factors. This paper presents general discussion of the method with help of a case study to illustrate the development of the model, whereas subsequent parts would focus on application of this model with practical examples. This not only attempts to creates objectivity of the entire process, but it develops awareness of the associated risks amongst shop floor operators, which can lead to reduction of the overall risk level of the process and improves the sterility assurance level.