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Abstract

ASEPTIC PROCESS SIMULATION: AN ASSESSMENT OF ASEPTIC PROCESSING CAPABILITY

*Aaishwarya Deshmukh

ABSTRACT

Aseptic process simulation (APS) is a critical validation procedure performed before implementing a new aseptically-manufactured product or aseptic process. It is the lynchpin of any qualification of an aseptic facility which requires careful consideration and design for successful implementation and thus should be carefully planned to ensure the length of the simulation and the number of manipulations performed during the fill which are representative of the actual process. APS requires their own batch records mimicking the process being simulated and includes particulars like number and type of aseptic manipulations, number of personnel, length of run, line speed, etc. It is becoming more challenging to stay on the wave of optimal and compliant sterile product manufacturing because of augmentation in technology and regulatory expectations. It is crucial for aseptic processing contract manufacturers to remain willing to seek, develop, and utilize innovative technologies, as efficiency of operations is essential to the effective operation of contract manufacturing organization. The past few years have been predominantly vigorous in context to changes that has been implemented in aseptic processing with some changes from shifts in approach to validation and process control as well apart from technology advancement.

Keywords: Aseptic process simulation, media fill, validation, sterile, aseptic manufacturing, intervention.


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