Basic Information
Model NO.
Customized IVEN -11
Dimension(L*W*H)
Customized
Core Components
Motor, PLC
Key Selling Points
Automatic; Easy to Operate
Heating
Electric Steam Generator
Heating Method
Hot Water/Steam/Electricity
Sterilization
Auto / Sterilization-I
Certification
CE, GMP, ISO
Function
Fermentation and Reaction
Bioreactor System Overview
Customized integrated engineering solutions are provided according to user needs in the biopharmaceutical industry. These systems are widely used in the fields of recombinant protein drugs, antibody drugs, vaccines, and blood products.
Integrated Solutions: Providing pharmaceutical companies with liquid preparation systems for vaccines, monoclonal antibodies, and recombinant proteins, including medium preparation, fermentation, harvesting, buffer preparation, and final preparation.
The system adopts a 3D modular design that is compact and efficient. Critical components such as tanks, pumps, heat exchangers, filters, and valves are selected from premium international brands to ensure overall system quality. The control system utilizes Siemens 300 series PLC and MP277 series HMI touch screens.
Quality Assurance & Automation
The design, inspection, and composition of automatic control conform to the V-model of GAMP5. The system realizes automatic control of production, cleaning, and sterilization, with complete verification documentation (RA, DQ, IQ, OQ) provided.
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Frequently Asked Questions
What industries are these bioreactors suitable for?
They are designed for the biopharmaceutical industry, specifically for recombinant proteins, antibody drugs, vaccines, and blood products.
What is the range of capacity available?
The capacity is highly customizable, ranging from small-scale 5L units to large-scale 20,000L production systems.
Does the system support automatic sterilization?
Yes, the system features automatic SIP (Sterilization-In-Place) and CIP (Cleaning-In-Place) capabilities controlled via PLC.
What control systems are used in the equipment?
We primarily use Siemens 300 series PLCs and MP277 series HMI touch screens to ensure global standard compatibility.
Are validation documents provided with the machinery?
Yes, we provide a complete set of verification files including Risk Assessment (RA), DQ, IQ, and OQ based on GAMP5 standards.
Can the system be customized for specific heating methods?
Yes, the system supports Hot Water, Steam, and Electricity heating methods depending on user requirements.
SJ medical
