Кваліфікаційні дослідження миючої машини скляних флаконів для стерильних форм

Abstract

The qualification work is devoted to the study of the effectiveness of the preparation of glass vials on an automatic washing machine within the framework of qualification tests in order to confirm that the equipment functions in accordance with the manufacturer's specifications and the requirements of good manufacturing practice. At the SAT-acceptance stage, an analysis of the documentation, parameters of communication systems and control units of the machine for washing and preparing vials was carried out. The effectiveness of the washing procedure was assessed by conducting studies for the absence of soluble substances of sodium chloride, alkalis, riboflavin. According to the test results, a washing procedure was determined, consisting of seven stages. The results showed that the system’s washing cycles, which consisted of ultrasonic cleaning, purified water rinsing, and a final rinse with water for injection, were sufficient for the preparation of sterile drug containers.