Tibbiyot buyumlari ishlab chiqaruvchi korxonalarda mikrobiologik monitoring tizimini takomillashtirish va uning samaradorligini baholash
Improving the microbiological monitoring system at medical device manufacturing enterprises and evaluating its effectiveness
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Abstract
The paper addresses the organization, improvement and evaluation of the effectiveness of the microbiological monitoring system at enterprises manufacturing medical devices. Regular control of the microbiological status of the production environment helps to ensure product safety and prevent biological risks. Monitoring covers the air of production premises, work surfaces, process equipment, the hands of personnel and the devices being manufactured. Systematic recording of results and their trend analysis make it possible to determine preventive and corrective actions in a timely manner.
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References
ISO 13485. Medical devices — Quality management systems — Requirements for regulatory purposes.
ISO 14698-1:2003. Cleanrooms and associated controlled environments — Biocontamination control — Part 1: General principles and methods.
ISO 14698-2:2003. Cleanrooms and associated controlled environments — Biocontamination control — Part 2: Evaluation and interpretation of biocontamination data.
World Health Organization. WHO good manufacturing practices for pharmaceutical products: main principles.