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The cell culture bag features good biocompatibility, extremely low extractables and leachable, and ensures the safety of the product. All materials in contact with the product have passed relevant validation requirements of CFDA for single-use system and meet USP standards.
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The system is designed with Siemens PLC+WinCC system, can be connected to SCADA data management system, all data can be recorded and exported, and supports audit trail, while complies with 21CFR Part 11 regulations.
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The system integrates optical dissolved oxygen sensor with DO resolution of 0.1% and control accuracy of ±2%, the pH resolution is 0.01 with control accuracy of ±0.02; and temperature resolution is 0.1°C with control accuracy of ±0.5°C; the weighing accuracy is ±3‰ with pressure accuracy ±of 2%.
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The default configuration provides 3 channels of gas supply: macro-sparge bottom gas supply (0.05 vvm oxygen, 0.05 vvm air, 0.025 vvm carbon dioxide), micro-sparge bottom gas supply (0.025 vvm oxygen), overlay gas supply (0.05 vvm oxygen, 0.05 vvm air). All use Swiss Vogtlin or German Bürkert mass flowmeter.
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1-2 way exhaust heating as standard (depending on the model of the culture bag); magnetic coupling stirring device with inclined angle at the bottom, speed 0-300 rpm, temperature control range 20-50 ℃.
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Mettler-Toledo high precision load cell unit.
3.Advantages