Material : Stainless steel and suitable for materials like Fermentation media, Buffers, reagents, glassware, plastic wares, and autoclavable Bioreactor.
The sterilization chamber is insulated with a minimum of 50 mm thick R. B Glass Wool, which is held in place by an outer cover of SS 304. A 0.3- micron vacuum break. Air filter provided on the sterile side for pressure equalization after vacuum creation.
All proess piping in contact with the chamber is fabricated from SS 304 with argon welding. All connections and fittings used are sanitary tri-clamp with silicone seals. All non-contact piping is fabricated from SS 304 with argon welding. All drain lines and exhausts are connected to a drain manifold. The pipelines should have a 2 % slope for full draining to prevent contamination. All pneumatic lines shall be polyurethane with aluminum die-cast connectors.
The process valves in contact with the chamber should be SS 304 contact parts with Teflon seat and tri-clamp connections. All automatic valves are to be pneumatically actuated angle valves. The valves are to be actuated by instrument air controlled via solenoid valves.
The jacket and chamber are provided with an over-pressure safety valve. The chamber is provided with a steam trap. The inside of the chamber and doors are to be finished to a surface finish better than the 0.8 Ra value. All other noncontact parts are to be polished to a surface finish better than 180 grit.
Process Management System
The sterilizer is designed to perform a wide range of tests and production programs to meet the latest regulatory requirements.
Temperature and Pressure Sensors
Two sensors are provided, one inside the chamber and one at the drain outlet. For accurate process control and recording, all sensors are connected to the PLC and Recorder. The system must have a least count of 0.10 C. A pressure transmitter to be connected to the chamber. The system should have a pressure least count of 0.002 bars. All utility lines are provided with a pressure switch for generating an alarm in case of utility failure.
The control cabinet is provided with a main isolator for the three-phase supply and a separate switch for the control supply. The fascia of the control panel is provided with indication LEDs and switches for operation.
All the switchgear: – Schneider do matrix data printer for recording, date, time, process parameters, process status, etc., shall be provided alarms with the machine.
The system is provided with a user-friendly HMI as a front-end user interface. Following minimum attributes shall be provided. RS 232 port for data communication. In-built Real-Time Clock with date and time function.
The process management system shall be provided with a series of safety and alarm features are as follows:
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