Terminal sterilization (TS) is a pivotal process in pharmaceutical manufacturing, ensuring sterility and enhancing patient safety for parenteral formulations. This presentation will delve into various TS methodologies and their selection criteria for diverse long-acting injectable formulations. The discourse will encompass steam sterilization, dry heat sterilization, and radiation sterilization techniques, emphasizing their underlying mechanisms, efficacy, and constraints. A substantial focus will be placed on long-acting injectable formulations, scrutinizing the physicochemical properties of drug substances and drug products that may be influenced during the TS method evaluation. Case studies and empirical examples will elucidate the decision-making framework employed in selecting appropriate TS methods for specific long-acting injectable products.
Learning Objectives:
Upon completion, participant will be able to use the knowledge to design their own experiments when it comes to choosing between the different options of terminal sterilizations of LAIs.
Upon completion, participants will be able to reflect on the key mechanisms and limitations of various terminal sterilization methods.
Upon completion, participants will be able to rank terminal sterilization techniques based on their suitability for different long-acting injectable formulations, considering physicochemical properties and formulation constraints.
