Throughout the biopharmaceutical process, the use of disposable bioreactors accounts for a high proportion, with a significant impact on the final product.
In the cell culture stage, bioprocess scale-up requires careful consideration of key parameters of process and equipment such as stirring method, temperature control, sparging strategy, pH control, and the need to maintain sterility throughout the process. It is essential to avoid cross-contamination and ensure the stability and uniformity of product quality.
In single-use bioprocessing, common pH and dissolved oxygen electrodes are traditional plug-in electrodes, used in conjunction with single-use bioreactors to achieve process control of pH and dissolved oxygen.
Single-use bioreactor bags are pre-sterilized by irradiation. The pH and dissolved oxygen electrodes, which are pre-calibrated before culture, are pre-calibrated before cultivation, then undergo high-temperature steam sterilization via the electrode sleeve. The sterile connectors on the electrode sleeve allow for quick and sterile connection with the sterile connectors on the bioreactor bag's electrode ports.
CytoLinX® Electrode Sleeve Components can fully meet the sterile monitoring conditions for pH, dissolved oxygen, and can be adapted to commonly used 225mm, PG13.5 threaded pH electrodes and dissolved oxygen electrodes, ensuring the airtightness of the assembled electrode shleeve. Two popular designs are available, including AseptiQuik® G connector and Kleenpak™ connector.
The expanding tube used in the CytoLinX® Electrode Sleeve Components is made of silicone, and the threaded plug is made of PSU material. Both materials have excellent biocompatibility and chemical compatibility. The components can withstand humid heat sterilization: temperature ≤ 135°C, 30 minutes, with strict and comprehensive material certificates and validation documents.
Validation documents:
USP<87> Non-cytotoxicity
USP<88> Class VI
ISO10993-4 Hemolysis
USP<85> Endotoxin
USP <788> Subvisible Particle
BPOG & USP<665> Extractable
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