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Tailored for ≥100mL LVP production (infusion bags/bottles).
Complies with GMP/FDA/EMA standards for sterile manufacturing.
Integrated SIP/CIP systems ensure full aseptic control.
High-efficiency design supports large-scale, continuous production.
Versatile application in basic infusions, nutrients, blood products.
Description
Introduction
The large infusion preparation system is a core pharmaceutical equipment specially used for the production of large-volume injections (LVP, usually ≥100mL, such as infusion bags and infusion bottles). Its design needs to meet the needs of large-scale, high-efficiency, and aseptic production. It is widely used in the preparation of basic infusions (such as glucose, sodium chloride), nutrient solutions, blood products, etc.
System composition
· Liquid preparation tank :
Capacity : 500L~10,000L (customized according to production scale).
Material : 316L stainless steel (corrosion-resistant, easy to clean), inner wall electrolytic polishing (Ra≤0.4μm).
Structure : Sandwich design (steam heating/cooling water circulation), multi-stage stirring (anchor type + turbine type agitator).
· Filtration system :
Three-stage filtration : pre-filtration (5μm) → activated carbon adsorption (optional) → 0.22μm terminal sterilization filtration.
Integrity test : Automatic bubble point test (to ensure that the filter membrane is not damaged).
· Conveying system :
Sanitary centrifugal pump : low shear design protects sensitive ingredients (such as proteins).
Pipeline network : Fully enclosed sanitary stainless steel pipeline, supporting CIP/SIP (online cleaning/sterilization).
· CIP/SIP system :
CIP : Multi-stage cleaning (pre-rinse → alkaline cleaning → acid neutralization → final cleaning), cleaning coverage ≥ 99%.
SIP : Pure steam sterilization (121 °C , 30 minutes), covering the tank, pipelines and filters.
· Control system :
Automation platform : PLC+SCADA system, preset formula program, real-time monitoring of parameters (temperature, pH, conductivity, liquid level).
Data integrity : Compliant with FDA 21 CFR Part 11, supporting electronic batch records (EBR) and audit trails.
Applicable Products
· Basic infusion : glucose injection, sodium chloride injection, compound amino acid infusion.
· Therapeutic infusion : large-volume infusion of antibiotics (such as cephalosporins) and infusion of chemotherapy drugs.
· Nutritional preparations : fat emulsion, vitamin compound infusion, parenteral nutrition solution (TPN).
· Biological products : human serum albumin, immunoglobulin diluent.
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