SED-4.86FDG-N — Máquina de secado por congelación
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The SED-4.86FDG-N is a full-GMP pharmaceutical vacuum freeze dryer with a 4.86 m² shelf area (SUS 304 stainless steel drying chamber) and a maximum load of 96 L of raw material per batch. The machine features advanced PI
Funcionamiento
Vacuum pressure is reduced by the vacuum system while the refrigeration system provides low-temperature shelf environment. Product is first frozen, then sublimation under vacuum removes bulk ice (primary drying), followed by secondary drying to desorb residual bound moisture. The control system supports both automatic and manual switching at any process node, with interlock functions between sterile room, machine room, and freeze-dry control room to prevent mis-operation.
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The sterile room is equipped with a hydraulic emergency stop button for forced shelf stoppage in emergencies. Cleaning of the chamber and pipelines shall follow GMP-compliant SOP; water-for-injection and purified water pipelines must be cleaned and disinfected per operating procedures with records kept.