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Dialysate Batching System
Product Details
- 产品描述
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The features of the dialysate batching system are designed around "precision, safety, and compliance" to meet the stringent requirements of hemodialysis treatment for the composition of dialysate. The project features are as follows:
High-precision batching control: Equipped with high -precision metering devices (such as load cells and precision flow meters), it accurately proportions electrolytes like sodium, potassium, calcium, bicarbonate, and raw materials (dialysis powder/liquid). It ensures that the ion concentration error is≤1%, and the osmotic pressure strictly matches that of human blood (about 300mOsm/kg), preventing patients from developing electrolyte disorders.
Strict water quality assurance: It integrates multi-stage water treatment modules (reverse osmosis, pyrogen -removal devices)to ensure that the water used for batching meets medical-grade standards(e. g. , complies with YY0572 requirements, endotoxin ≤0. 03EU/ml, total organic carbon ≤50ppb), controlling the pollution risk from the source.
Efficient mixing and dissolution: Considering the differences between medium A and medium B, it reasonably selects anti-corrosive materials fortanks, fluid pipes, fittings, and valves. A customized stirring device(such as a low-shear stirring paddle) is used to ensure that the dialysis powder dissolves quickly and uniformly, avoiding crystallization due to local high -concentration (such as sodium bicarbonate), and preventing excessive stirring from introducing bubbles that may affect subsequent treatment.
On-line monitoring and closed-loop control: It monitors key parameters such as pH value, conductivity, and temperature in real -time. Through the PLC system, it automatically adjusts the batching ratio to ensure that the indicators remain stable within the set range(e.g., pH7. 3-7. 5). In case of abnormalities, ittriggers an alarm and stops the machine to ensure batch consistency.
Cleanliness and sterilization design: The parts in contact with the materials are made of 316L stainless steel with electrolytic polishing on the surface (Ra≤0. 6μm), supporting in-line cleaning (CIP) and in-line sterilization (SIP) to prevent microbial growth and cross -contamination, meeting the GMP requirements for sterile preparation equipment.
Full -process traceability: It integrates a data acquisition system that automatically records raw material information, batching parameters, operation time, test results, etc. forming an unalterable audit trail record to meet the regulatory compliance requirements of medical devices by FDA, CE, etc.
Flexible adaptability: It can be compatible with different formulas (such as low- calcium and high-sodium dialysates), support batch -type or continuous production, and adapt to the small-batch and multi-variety needs of scenarios such as hospital dialysis centers and hemodialysis equipment manufacturers.
PID Flowchart forLiquid A Batching
PID Flowchart forLiquid B Batching
Keywords:
Pharmaceutical equipment
chemical equipment
pressure vessel manufacturing
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