Automatic filling machine Moduline™

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Protection and containment equipment It is the highest available level of containment for both sterile and toxic products, equipped with a hermetic chamber, rapid transfer ports (RTP) and predefined action protocols. The system features a dedicated decontamination system (VHP), sterility control, particle sampling and operating parameters that allow operating in an ISO 8 or class D classified room. Due to the growing concern for product and operator protection and the complex regulatory framework of the pharmaceutical industry, it became essential to design the processing equipment together with the containment system. Aseptic pharmaceutical manufacturing requires the production area to be free from microbiological and particle contamination. The environmental conditions for sterile processing are designed to maintain product sterility and are ISO 5 or Grade A classified, considering the following parameters: Particle level (> 0.5 μm) less than 3,520 particles/m3. Vertical air flow laminarity. Humidity control. Temperature control. Air recirculation. Cleaning and decontamination procedures.