Industry 4.0
Vol. 6 (2021), Issue 6, pg(s) 211-214

TECHNOLOGICAL BASIS OF “INDUSTRY 4.0”

Sterile Manufacturing Quality Control Methods in the Medical Products Industry

  • 1 Kaunas University of Technology, Faculty of Mechanical Engineering and Design, Kaunas, Lithuania

Abstract

Manufacturing of medical products is a very wide market. Many steps must be taken to ensure that produced product is sterile and safe and efficient to use for the customer. All manufacturing system from production floor to the type of sterilization must comply with required standards and regulatory. Every step of introducing new product to the production to routine production itself must be well documented and justified to be able to release the product to the market for human consumption. This paper presents information of production area requirements for medical devices, sterilization methods and sterilization indicators, briefly overlooks the q uality control of such processes and the effectiveness of it.

Keywords

References

  1. Manmohan Singhal, MD. Habban Akhter, Devesh Kapoor, Lakshmi Kanta Kanthal, Yashu Chourasiya, Rahul Maheshwari, Anil Pethe, Rakesh K. Tekade. Advancements in sterile products and admixtures. The Future of Pharmaceutical Product Development and Research. Academic Press (2020)
  2. Sam A. Hout, Sterile manufacturing. Regulations, processes, and guidelines (2021)
  3. M. Gudeppu, S. Sawant, C. G. Chockalingam, & P.S. Timiri Shanmugam. Medical device regulations. Trends in Development of Medical Devices (2020)
  4. Laurence W. McKeen, The Effect of Sterilization on Plastics and Elastomers (2018)
  5. Moondra, Shruti. Dosage Form Design Parameters. Sterilization of Pharmaceuticals Technology, Equipment, and Validation (2018)
  6. Hu, Shih-Cheng; Shiue, Angus. Validation and application of the personnel factor for the garment used in cleanrooms, Building and Environment (2016)
  7. https://www.pharmamicroresources.com/2018/02/distributi on-of-particles-within.html
  8. https://www.pharmaguideline.com/2012/07/overview-of-iso-14644-clean-room.html
  9. Fatima Hasanain, Katharina Guenther, Wayne M. Mullett and Emily Craven. Gamma Sterilization of Pharmaceuticals. A Review of the Irradiation of Excipients, Active Pharmaceutical Ingredients, and Final Drug Product Formulations. PDA Journal of Pharmaceutical Science and Technology March, 68 (2) 113-137 (2014).
  10. Novikova Ye, Indicators of sterilization of medical products. National University of Pharmacy (2020)
  11. William L. McLaughlin, Radiation measurements and quality control. , 9(1-3), 147–181 (1977)
  12. V. N. Ponomarev, A. A. Molin, V. V. Kalashnikov, Ju. A. Drabkin. QC/QA system in radiation sterilization process on E-Beam irradiation plant, Department of radiation technologies of state research center (2006)

Article full text

Download PDF