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Fermentation Equipment for Pharmaceuticals/Aseptic Fermentation System

Min.Order: 1
Product origin: Shanghai, China
Infringement complaint: complaintComplaint
US$ 50000 ~ 500000

Description
Pharmaceutical & Medical Factory Meets the GMP Production Standard Bioreactor 
A bioreactor is a vessel in which raw materials under controlled conditions are converted into products by action of living cells (microorganisms, mammalian, plant and stem cells and algae) or by the cellular components such as enzymes.


Product Description
IVEN provides professional services in engineering design, processing and manufacturing, project management, verification, and after-sales service. It provides biopharmaceutical companies such as vaccines, monoclonal antibody drugs, recombinant protein drugs, and other biopharmaceutical companies with individualization from laboratory, pilot test to production scale. A full range of mammalian cell culture bioreactors and innovative overall engineering solutions. The design and manufacture of bioreactors strictly follow GMP standand, adopt professional, user-friendly, modular design, and perfect and flexible structural design combinations to meet the requirements of cell batch culture.

It is composed of a tank unit, a stirring unit, a jacket temperature control unit, a four-way air inlet unit, an exhaust unit, a feeding and replenishing unit, a sampling and harvesting unit, an automation control unit and a common medium unit. The self-control program complies with the S88 international standard, with a clear structure, complete historical data recording, storage, management, trend graph display and training data analysis functions, in line with GAMP5; audit trail function (electronic record/electronic signature), in line with CFR 21 PART11.

The product is suitable for the full-suspension culture, sheet carrier culture and microcarrier culture of biological drugs such as antibodies and vaccines (such as rabies vaccine, FMD) and other biological drugs in the pilot and production scale.
 
Specification
item
value
Type
Fermentation Extraction
Condition
New
Video outgoing-inspection
Provided
Machinery Test Report
Provided
Marketing Type
New Product 2021
Warranty of core components
1 Year
Core Components
PLC, Engine, Bearing, Gearbox, Motor, Pressure vessel, Gear, Pump
Place of Origin
China
Weight
2500
Warranty
1 Year
Key Selling Points
Long Service Life
Applicable Industries
Manufacturing Plant, Medical, Pharmaceuticals
Showroom Location
Egypt, Turkey, United Kingdom, Brazil, Russia, Algeria, South Africa, Nigeria, Uzbekistan, Tajikistan
Product name
Meets the GMP Production Standard bioreactor industrial
Mixing speed
fermenter special motor
PH control
Intelligent PID control
Material
304; 304L
Tank automatic sterilization system
automatic program sterilization
Tank automatic cleaning system
tank automatic cleaning system
Foam control
peristaltic pump refoaming agent, automatic control;
Tank pressure
Automatic adjustment, digital display
After-sales Service Provided
Online support;Field maintenance and repair service
Parameters
Bioreactor only works well when it meets specific parameters like temperature, mixing rate of microorganisms, uniform nutrient transfer, and gassing.
  • Culture mixing: The culture for the bioreactor must be mixed constantly and carefully to ensure the proper mixing of nutrients and maintain the suitable pH and temperature among cells. The mixing rate varies according to the organisms used for culturing. For example, the rate for mixing fungi and yeast is 500-1500 per min, and for mammalian, insect, and plant cells is 30-300 per min
  • Temperature and pH: Correct temperature and pH play crucial roles in the processes occurring in the bioreactor because culture cells and enzymes work efficiently in certain temperatures and pH. The specific temperature range for bacteria, fungi, and yeast cells is 20 °C to 60 °C, and the pH range for these organisms is 4.5-7.
  • Nutrient required:    Depending on the bioprocess strategy, nutrients such as water, energy sources like glucose, carbon, salt, and other trace elements (e.g., vitamins) are either added gradually over time (in a fed-batch or continuous process) or made available at the start of a bioprocess (batch bioprocess).
  • Construction material: The materials (glass or stainless steel) used during construction should withstand the pressure and have to be anti-corrosive.
  • Ideal foam collector: The ideal bioreactor must have a foam controller to prevent various side effects caused by it. The detector must sense when the foam touches it so that it adds the anti-foaming agent to a fermenter.
  • Supplying air:   The continuous stirring causes disturbance in nutrients and reduces bubbles' size. So, it is essential to release the air molecules in the nutrient broth as air molecules are taken by the cell only when it dissolves in the nutrient solution. The demands of air molecules depend on the types of organisms or cells used (aerobic or anaerobic) and the fermentation phase. At the very beginning, only a few amounts of oxygen are needed, but the supply of oxygen is increased as there is faster growth of cells.
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