Keywords
How to Cite
Abstract
This article analyzes the importance of microbiological control in medical device manufacturing enterprises using the example of the Nukus Med Tex manufacturing enterprise. Systems for maintaining sterile conditions, preventing contamination with microorganisms, and quality control at the manufacturing enterprise are considered. Information is also provided on practical laboratory monitoring methods and their effectiveness.
References
1. Medical Microbiology — Geo F. Brooks, Karen C. Carroll, Janet S. Butel. Medical Microbiology. New York: McGraw-Hill Education, 2020.
2. World Health Organization. Guidelines on Sterility Assurance in Medical Device Production. Geneva, 2019.
3. International Organization for Standardization. ISO 11737-1:2018. Sterilization of Health Care Products — Microbiological Methods.
4. International Organization for Standardization. ISO 13485:2016. Medical Devices — Quality Management Systems.
5. United States Pharmacopeia. USP <71> Sterility Tests. United States Pharmacopeial Convention, 2021.
6. O‘rinboyev O.X., Karimov Sh.A. Mikrobiologiya va sanitariya asoslari. Toshkent: “Fan” nashriyoti, 2021.
7. Axmedov A.A. Tibbiy mikrobiologiya. Toshkent, 2020.
8. Pelczar M.J., Chan E.C.S. Microbiology. New York: McGraw-Hill, 2018.
9.Prescott L.M. Industrial Microbiology and Biotechnology. Boston, 2019.
10. Meditsina buyumlarini sterilizatsiya qilish va dezinfeksiya bo‘yicha O‘zbekiston Respublikasi sanitariya me’yorlari va qoidalari (SanPiN).