SanQiang PH-Ferment
Sanqiang PH-Ferment is the state of the art solution for any microbial fermentation process.
Whether for individual fermenters or multi-stage fermentation systems, sterile design and hygienically designed components are applied to meet the customer’s highest requirements and comply with national (GMP) and international (cGMP/FDA) pharmaceutical standards.
Excellent process result in terms of quality, accuracy and repeatability is granted by controlling pH, pO2, temperature, agitator speed and weight through precise instrumentation.
The comprehensive Factory Acceptance Test (FAT) in the plant enables a quick start-up at site.
Application
Pharmaceutical, Bio-Pharma.
Design Features
· Sterile design, non-dead-angle activity area
· ASME BPE Design
· Skid-mounted,
· Material of product contact surfaces: AISI 316L
· Orbital welded pipework
· Integrated CIP / SIP
· Baffles, removable
· Touch-screen operating concept, with process shown in the active flow diagram
· Continuous monitoring of the production and recording function
· Customized solutions
Technical Specifications
· Capacity: 10 litres – 20,000 litres
· Working volume : 10, 20, 30, 50, 100, 300, 500,1,000; 1,500 litres
· Internal surface: Ra ≤ 0,4 µm electro-polished
· External surface: Ra ≤ 0,6 µm mechanical-polished
· Tank Pressure: -1/+3 bar
· Jacket Pressure: +1/+4 bar
· Coefficient of filling liquid: 65%-75%
· Temperature: -20 / +150 °C
· Cleaning Options: CIP, SIP
· Seal Mode: double face mechanical seal
Automation
A programmable logic control (PLC) which satisfy 21 CFR Part 11 standard, controls and regulates the process. The system offers the following functions during operation:
· Stirring with adjustable speed: 0 to 600 rpm
· Air detection: analysis of carbon dioxide
· Pressure regulation of exhaust air
· Temperature control
· Filling with nutrient medium
· Inoculation
· Product harvest
· Sterilisation of the nutrient medium by means of temperature control
· Empty sterilisation with high purity steam
· Date print
· Date Storage
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