Biopharmaceutical Process Module GMP 2

Biopharmaceutical Process Module GMP 2

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Description

Description for 100L fermenter system

Description

1、Equipment description
VesselTTL volume: 100L
D:H rate: 1: 2.5;
Working volume:70%-75%
The vessel material is stainless steel 316L. The internal surface of vessel is polished with Ra ≤0.4um
The jacket is 304, the surface polishing precision Ra≤1.2µm, all welds are firm and neat and beautiful. The material for automatic welding shall comply with the chemical composition described in the DT3 table of ASME BPE2009
500L vessel thickness:6mm.
Vessel design pressure: 0.1-0.35MpaJacket design pressure: 0.4 Mpa, Design temperature: 150 ℃
Provide pressure vessel certificate, with insulation layer
Vessel function: with special discharge valve for fermentation liquid discharge and transferring.Adopt large sight glass for liquid level observation, 12V safety sight light.
Vessel interfaces for intake sterilization filter, exhaust condenser, air intake system with air distributor, feed port, cleaning port, discharge port, sampling port, 4 replenishment material ports, pressure gauge port.
Stir systemStir method: upper single mechanical seal. Single axis, micro taper and high speed type. Material contacting with the broth is 316L. Precision processing, ideal dynamic balance performance, good rigidity, long-term use without deformation; The entire system is safe and stable and long life.
Stirring motor: adopts SEW AC motor. Variable frequency, low noise (below 60dB), high temperature resistance (above 125 ℃);
Stirring type: flat vertical paddle / rushton impeller (2 grades), middle-grade is pitched paddle, mechanical antifoaming paddle (1 grade), four baffles;
Stirring speed: 50 ~ 1000rpm stepless speed change; accuracy: ± 1rpm;
Stirring power: 100L 1.5KW
Sterilization systemAutomatic sterilization for empty tank and tank filled liquid, and supports manual operation sterilization; The pure steam main pipe is provided with a steam-water separation device, a pressure reduction device and a filtration device. The pure steam enters the tank through the air filter element; The steam pipeline is added with a steam trap, and steam enters the jacket ; Sterilization temperature requirements: 121 ~ 125 ℃. From the start of sterilization to cooling to 30 ℃, the sterilization for empty tank does not exceed 1h, the sterilization for tank filled with liquid does not exceed 1.5h
Sampling systemAdopt aseptic sampling valve can realize multiple aseptic sampling in situ, without dead angles and material accumulation, and can be independently sterilized in situ. The sampling position is set at the bottom of the tank, and it is connected to the transplanting pipeline. The sampling valve uses a four-valve group and a separate pure steam sterilization pipeline system.The sampling valve is a sanitary-grade closed sterile sampling valve, which can be used separately, multiple times Sterilized in situ.
Air intake systemThe filter element interface is a standard 5-inch, 0.22 micron air filter element.
The ventilation mode is deep ventilation. The deep ventilation pipeline enters from the lower side shell of the tank body and the pipeline has a non-return device. The circular air distributor can evenly ventilate around;
The air intake method is automatic and manual. The mass flow meter is automatically controlled, and the rotor flow meter is manually assisted.
On-line integrity detection interface is reserved for intake line.
The mass flow meter range:100L: 0-200L/min.
Operating modeThe deep ventilation sterilization mode is set according to the sterilization temperature, and related the air valve, steam valve and exhaust valve;The pressure-holding mode is set according to the tank pressure and tank temperature, and related the intake valve, exhaust valve, cooling water valve, etc.
Gas filtrationThe off-gas exhausts through the condensing section, the gas sterilization filter and the pressure regulating valve in order, and then is discharged.
The filter element interface is connected to a standard 5-inch, 0.22 micron air filter element, and the filter can be SIP;
The device for anti-running fluid and filter element blocking are reliable, and the exhaust gas filter is equipped with a heating device.
On-line integrity detection interface is reserved
Pressure controlGerman BD pressure electrode is for digital display.
Automatically control the required tank pressure through off gas adjustment, etc., and record the pressure change curve during the fermentation process.
Range:-0.1~0.25Map;precision:± 0.01
PH controlUsing the Hamilton intelligent pH electrode for fermentation,
Control Range:2~12,display range:0~14,control precision:±0.02, resolution:0.01%。
Using intelligent PID control, the peristaltic pump automatically replenishes acid / alkali;It can make the pH control performance very good, and with historical and trend curve for analysis;
DO controlUsing Hamilton DO optical electrode for fermentation
Control range:5~100%,display range:0~150%,control precision:±2%,resolution:1%。
Using intelligent PID control, which can be related to the speed; The dissolved oxygen parameter control has achieved a very satisfactory effect;With fermentation process control, history and trend curve for analysis
Temperature controlTemperature control module : with jacket, intelligent PID control;
Including electric heaters, circulating pumps, detection devices, valves, safety protection devices, controls module and pipelines, and adopts a fully enclosed pipeline design.
The temperature is controlled by chilled water (normal temperature water is used to lower temperature after sterilization) and electric heating for exchange.
Temperature control range: 15 ~ 50 ℃; accuracy: ± 0.1 ℃; Resolution: 0.1 ℃
Feeding controlPerfect feeding system (acid, alkali, antifoam, feeding material), which can be fed regularly and quantitatively;
Four peristaltic pumps can be selected in sections on the control interface,
Automatic feeding and manual feeding can be switched at will, which is convenient and flexible in actual use.
Antifoam controlElectrode detection, peristaltic pump supplies defoamer.
PID automatic control and alarm, sensitivity 100 ~ 100000Ω,
Control mode: PLC full digital signal processing, digital setting control
Liquid measurementUse Melttler weighing module, accuracy : 1/3000
Lid liftingOnly for <1000L vesselUsing Taiwan Limtek electric linear lift, safe and convenient. Lift the lid 40cm or more.
Seed transferThe seed transfer pipeline of the fermentation tank is located at the bottom of the tank body, and the material is AISI 316L.The seed transfer pipeline is equipped with a sanitary diaphragm valve to realize the online sterilization function without dead angle;
PipelinePipeline: All pipelines are sanitary grade, 316L material, and the sanitary contact part Ra <0.4um, using automatic orbital welding technology, 99.999% purity argon is used as protective inert gas, and the pipeline and the whole system are pickled and passivated.
ValvesValves: All valves and meters installed on the pipeline where is in direct contact with raw water, steam, and compressed air are hygienic grade. The blind pipe meets the 3D requirements and does not cause secondary pollution to the product;
SafetyThe bursting disc is installed on the tank lid; The steam pipeline (tank side) is equipped with a safety valve to prevent overpressure.
MarkThe high-temperature and high-pressure parts are marked with colors and warning signs.
The pipeline direction and purpose are marked;
Each valve is marked with serial number and description .
UPSWhen power is fault, the valve will close automatically to prevent any out of control condition.
Equipped with UPS to ensure that the entire program section, data, ratings, etc. are stored safely for at least 5 minutes when the power supply fails.

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