Study on Designing and Quality Aspects of Aseptic Process Simulation

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Study on Designing and Quality Aspects of Aseptic Process Simulation

July 3, 2021 Pharmaceutical 0

Aseptic process simulation is a critical validation technique used before introducing a new product or aseptic process into the facility, as well as to demonstrate at regular intervals that existing manufacturing operations are carried out under aseptic conditions. This review discusses the nature of the study involved in aseptic process simulation, as well as the speed and number of runs, runtime, atmospheric conditions, line speed, the media used, incubating and analyzing media-filled units, and data interpretation. It also focuses on worst-case parameters, interventions, case studies on interventions, and regulatory aspects related to simulation. Aseptic process simulation is a critical validation technique used before introducing a new product or aseptic process into the facility, as well as to demonstrate that existing manufacturing operations are carried out under aseptic conditions at regular intervals. This review discusses the nature of the study, as well as the speed and number of runs, runtime, atmospheric conditions, line speed, the media used, incubating and analyzing media-filled units, and data interpretation. It also focuses on worst-case parameters, interventions, intervention case studies, and regulatory aspects of simulation.

Author (S) Details

S. Hemanth Kumar
Pharmaceutical Quality Assurance Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Sri Shivarathreeshwara Nagara, Mysuru-570015, Karnataka, India.

Teja Sri Maddirala
Pharmaceutical Quality Assurance Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Sri Shivarathreeshwara Nagara, Mysuru-570015, Karnataka, India.

T. Shailesh
Pharmaceutical Quality Assurance Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Sri Shivarathreeshwara Nagara, Mysuru-570015, Karnataka, India.

M. P. Gowrav
Pharmaceutical Quality Assurance Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Sri Shivarathreeshwara Nagara, Mysuru-570015, Karnataka, India.

D. V. Gowda
Pharmaceutical Quality Assurance Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Sri Shivarathreeshwara Nagara, Mysuru-570015, Karnataka, India.

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