SIP in Pharmaceutical Lyophilizers

SIP in Pharmaceutical Lyophilizers

The sterilization-in-place (SIP) lyophilizer for pharmaceuticals is designed and manufactured in accordance with the standards for pressure vessels. The inner surface of the device can withstand sterilization with saturated steam at 121°C (1.3barg). All wetted surfaces of the chamber, door, and cold trap are made of AISI316L stainless steel. The locking of the main door is locked by the latch lock located around the door, and the movement of the door is driven by the cylinder located in the mechanical room. This structure avoids the generation of particles that may occur in the sliding latch door and the crossover from the non-sterile environment. risk of contamination. The operation of the automatic door lock is interlocked with certain conditions and activated by a button.

The outer surface of the box body, box door, and cold trap is made of glass fiber insulation material, covered with polymer foam material and a metal cover plate.

The sterilization process is automatically controlled, based on the chamber pressure and the temperature of the chamber, cold trap, and filter outlet. Once the temperature at these points reaches the set temperature, the timing of steam sterilization begins. If the temperature is lower than the user set value, the set sterilization program will be restarted. Pressure transmitters installed in the tank and cold trap are used to control the supply of steam.

A water ring pump removes air and moisture from the system during sterilization and dries the system after sterilization. Sterile nitrogen or air for vacuum control enters the chamber through a sterile air filter module (if supplied). The filter and housing can be sterilized in place. Insulation of the filter housing and associated piping tape ensures that the sterilization temperature is reached, reduces condensation, and aids drying later in the sterilization process.

The sterilization program is initiated and controlled by the PLC of the SCADA control system. The user can set the control temperature and time on the control system. In order to minimize the amount of steam entering the user drainage system, a steam cooling system is provided to spray the hot wastewater waste steam generated during the SIP process. To add SIP-related data logging, a 12-point recorder is provided. Use polished, clean diaphragm valves in place of standard clean butterfly valves. The box/cold trap discharge valve, vacuum pump set, and vacuum control valve do not use diaphragm valves.

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