Product Introduction
As the core equipment of GMP-compliant single-use production systems, Disys 500L-5000L Single-Use Bioreactor is designed for large-scale biopharmaceutical manufacturing, covering the full process from 500L pilot scale to 5000L commercial production. The system combines single-use sterile bags with stainless steel support structures, eliminating the cleaning validation costs associated with traditional stainless steel reactors while enabling stable scale-up of processes such as cell culture and protein expression through modular control. It is suitable for the high-efficiency production of biologics including antibodies, vaccines, and cell therapies.
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Dimension |
Description |
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Application Scenarios |
Pilot/commercial production of biologics (antibodies, recombinant proteins, vaccines, cell/gene therapies) |
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Core Advantages |
1. GMP-compliant, meeting 21 CFR Part 11 requirements; |
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Compliance |
Complies with industry standards such as USP Class VI and ISO 13485; provides complete IQ/OQ documentation |
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Item |
Specification (500L-5000L) |
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Working Volume |
70% filling volume (350L-3500L) |
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Material |
Single-use bag: USP Class VI TPE; Support structure: 316L stainless steel |
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Sterilization Method |
Single-use bag: Gamma-irradiated (supplied sterile) |
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Temperature Control |
Jacket temperature control, range: RT+5℃~65℃, accuracy ±0.1℃ |
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pH Control |
Range 2-12, accuracy ±0.1pH, PID automatic adjustment |
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Dissolved Oxygen (DO) Control |
Range 0-200%, accuracy ±5%, supporting aeration/stirring linked adjustment |
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Agitation System |
Overhead magnetic drive, speed 0-1000rpm, accuracy ±0.5% |
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Aeration System |
Mass flow meter control, supporting multi-gas (air/oxygen/nitrogen) |
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Control Software |
Complies with GAMP5; supports audit trail, data recording, and batch report generation |
