Stainless steel (SS316L grade) vessels in total volumes of 20L to 20kL are offered as standard. The working volume of these vessels are rated between 60 to 80% of total volume. The vessels are designed in D/H ratios of 1:2 or 1:3 depending on a combination of user requirements as well as vessel volume requirements. Custom sizing can be offered on request.
All contact parts in vessel is SS316L. The vessel is fabricated (GTAW welding to ASME Sec IX) in an exclusive SS316L only fabrication bay complete with PVC curtain containment to avoid ingress of carbon contaminants. Vessel is finished with Ra < 0.6µm surface roughness internally and with Ra < 1.2µm surface roughness externally. Electropolishing surface finish offered as option. Vessels are designed & finished in accordance with ASME Sec VIII Div 1, ASME BPE, ASME B912, ASTM A967 & ASTM A380 standards.
Main Vessel is provided with an adequate number of ports. Ports are included for pH Sensor, DO Sensor, Foam Sensor, Temperature RTD Sensor, Air Sparger & Bypass, Air Exhaust, Agitation, Agitation, Acid/Alkali/Foam Influx, Inoculum Influx, Feed Inlet and Harvest Outlet. All ports are designed to prevent contamination cross-over. Seals are pharma-grade O Rings. Sight glass is included as standard for reaction monitoring. Sensor ports (Ingold type) are fabricated circumferentially on lower portion of the vessel.
Piping & Valves:
All piping are in SS316L internally polished as per ASME BPE norms. All piping are GTAW welded inside same PVC curtain containment as vessel. Automatic valves are internally electropolished diaphragm type pneumatic valves as per ASME BPE norms. Sampling valves & vessel bottom drain valves are ZERO dead leg valves.
For precise temperature control, water jacketing system is offered with automatic on/off valve. Suitable spray ball design is offered for effective CIP/SIP process. DQ, IQ, OQ, PQ validation is offered with documentary support.
Agitation is achieved by radial or axial flow impellers. System is complete with double mechanical seal & PLC/PID control. Speed ranges from 50 to 500 rpm. Measurement accuracy within + 2 rpm.
Air supply inlet includes re-usable, auto-clavabale 0.2µm hydrophobic air filter. Air feed to vessel is via fixed or removable sparger depending on customer option. Air feed flow is controlled via included automatic mass flow controller (controlled via PLC/PID system). Supplmentary gases (O2, CO2 or N2) feed lines can be offered as option.
Exhaust line is also includes re-usable, auto-clavabale 0.2µm hydrophobic air filter. Exhaust flow is controlled by automatic discharge valve to control vessel back pressure. Stainless steel condensor and heater can be offered as option.
The jacketed vessel temperature is maintained through side-mounted PT-100 temperature probe and associated PLC/PID system. Control range is 0 to 125ºC. Operating range is up to 85ºC. Measurement accuracy is + 0.1ºC.
The working fluid pH is maintained through auto-clavable gel filled glass pH electrode and associated PLC/PID system. Measurement range is pH 0 to pH 14. Measurement accuracy is + 0.1 pH.
Dissolved Oxygen (DO):
The DO inside the vessel is maintained through auto-clavable galvanic DO probe and associated PLC/PID system. Measurement range is 0 to 100%.
In addition to air/gases, the working fluid reaction process is controlled by addition of alkali, foam, inoculum and/or feed to the reactor/fermenter. This is done via included peristaltic pumps. These pumps are offered to run as fixed or variable speed pumps depending on process requirement.
PLC/PID Control System:
All controls indicated above are married to the central nervous system of the reactor/fermenter namely, PLC/PID control system. The control system is offered with necessary software for data logging, archiving controlled parameters, audit trail display, interlock trends and such parameters in accordance with 21 CFR Part 11 of USFDA regulations. Display parameters are rendered in a graphical interface for easy reference. Control panel with touch screen interface is standard. The system can be configured with variable access user account control to avoid foul play. Computer interface is via RS232 serial port/USB port. Panel includes electrical safety cut-off switch and is rated at 415V/50Hz or 480V/60Hz.