DESIGNING AND QUALITY ASPECTS OF ASEPTIC PROCESS SIMULATION

  • TEJA SRI MADDIRALA Pharmaceutical Quality Assurance Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagara, Mysuru 570015, Karnataka, India
  • HEMANTH KUMAR S. Pharmaceutical Quality Assurance Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagara, Mysuru 570015, Karnataka, India
  • SHAILESH T. Pharmaceutical Quality Assurance Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagara, Mysuru 570015, Karnataka, India
  • GOWRAV M. P. Pharmaceutical Quality Assurance Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagara, Mysuru 570015, Karnataka, India

Abstract

Aseptic process simulation is a crucial validation technique carried out before a new product or aseptic process is introduced in the facility and also to prove on regular intervals that the existing manufacturing operations are carried out in a state of aseptic conditions. Aseptic process simulation involves conducting aseptic production using a sterile growth medium instead of actual drug solution and excipients. The processes involved in aseptic validation include the identification of process mechanisms, variables and control methods and that also include product, component, and sterilization of equipment, sanitary facilities, environmental checks and staff training on gowning procedure. This review addresses the nature of the study involved in aseptic process simulation, speed and number of runs, runtime, the atmospheric conditions, line speed, the media used, incubating and analyzing media-filled units, data interpretation, worst-case parameters, interventions, case study on interventions and the regulatory aspects concerned with the simulation.

Keywords: Aseptic Process Simulation, Validation, Media, Interventions, Gowning procedure

Author Biographies

TEJA SRI MADDIRALA, Pharmaceutical Quality Assurance Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagara, Mysuru 570015, Karnataka, India

Ms Teja Sri Maddirala is currently pursuing Masters in Pharmaceutical Sciences, Quality Assurance group, at JSS College of Pharmacy, Mysuru, JSS Academy of Higher Education and Research, Mysuru, India. She received Bachelor in Pharmacy at Chebrolu Hanumaiah Institute of Pharmaceutical Sciences - [CHIPS], Guntur,  She is currently pursuing her internship at Hetero Laboratories Hyderabad as part of her Master project work, working on Aseptic Filtration, Continuous process verification and Quality Management aspects.

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

Shailesh T is currently Lecturer at JSS College of Pharmacy, Mysuru at JSS Academy of Higher Education and Research; He has more than 7 years of experience which includes 2 years in teaching and 5 years of Industry. He holds a Doctor of Philosophy degree in Pharmaceutical sciences, and actively involved in teaching and research. His area of research includes Pre Formulation Studies of Drugs and Excipients, Crystal analysis Formulation and Development.

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

M P Gowrav is currently Lecturer at JSS College of Pharmacy, Mysuru at JSS Academy of Higher Education and Research; He has more than 8 years of experience which includes 5 years in teaching and 3 years Research. He holds a Doctor of Philosophy degree in Pharmaceutical sciences, and actively involved in teaching and research. His area of research includes Formulation of Anti Diabetic formulations, Regulatory aspects of Drug registration, Validation studies

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MADDIRALA, T. S., S., H. K., T., S., & M. P., G. (2020). DESIGNING AND QUALITY ASPECTS OF ASEPTIC PROCESS SIMULATION. International Journal of Applied Pharmaceutics, 12(4), 17-23. https://doi.org/10.22159/ijap.2020v12i4.37410
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