GMP Sanitary Bioreactor

GMP Sanitary Bioreactor
GMP Sanitary Bioreactor
GMP Sanitary Bioreactor
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(Stainless Steel Aseptic Bioreactor, SUS316L)

The GMP Sanitary Bioreactor is engineered to meet the rigorous demands of high-quality vaccine production and large-scale manufacturing. We provide professional bioreactor systems that fully comply with GMP requirements. Constructed from SUS316L, the surface undergoes electrochemical polishing to achieve a precision of Ra≤0.2µm, ensuring a smooth, dead-leg-free finish that is easy to clean. We support customizable capacities from 5L to 10,000L, covering everything from R&D laboratories to industrial-scale production.

Furthermore, we provide a comprehensive documentation package to support your GMP certification, including: FAT (Factory Acceptance Test) reports, Material Certificates, and DQ/IQ/OQ/PQ Validation Support Documents.

Key Parameters
  • Capacity: 5L-10,000L (customizable)
  • Vessel Material: SUS316L Stainless Steel
  • Surface Finish: Electropolishing, Precision Ra≤0.2µm
  • Working Volume: 30% - 75%
  • Temperature: Dual-direction control (Heating/Cooling); Precision: ±0.2℃
  • pH: 0-12 (±0.01), Automatic bi-directional regulation (Acid/Alkali)
  • DO (Dissolved Oxygen): 0-200% (±0.1)
  • Sterilization: Fully Automatic SIP (Steam-In-Place). Includes sterilization timing, pressure holding, and independent filter sterilization
  • Pressure: 0 - 3 bar (±0.01), supports digital setting and automatic regulation
Core Advantages
Strict Sanitary Design & Materials

The SUS316L stainless steel vessel is electropolished to a precision of Ra≤0.2µm. The surface is smooth, dead-leg free, and easy to clean.

Sanitary Interface Components

Our bioreactor is equipped with dead-leg free and aseptic sampling valves, standard flame inoculation ports, and sanitary bottom valves to ensure a sterile environment during sampling and harvesting.

Real-time Visual Monitoring

Features a wide-angle longitudinal sight glass equipped with high-intensity LED lighting for clear observation of the fermentation state inside the vessel.

Technical Documentation Download
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