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Designed for ≥100mL LVPS (infusion bags/bottles).
GMP/FDA/EMA compliant with sterile process validation.
SIP/CIP integrated for full aseptic control.
Precise mixing/pH/osmolarity ensures batch consistency.
Modular for commercial-scale production across container types.
Description
Introduction
Large Volume Parenteral Solution Preparation System is a core equipment used to produce large volume parenteral solutions (usually with a capacity of ≥100mL, such as infusion bags, bottled infusions, etc.). Its design must comply with GMP , FDA/EMA and other regulatory requirements to ensure the sterility, uniformity and stability of the drug solution. The following is a detailed description, function and design principle:
System composition
The large-volume injection preparation system consists of the following key modules:
· Liquid preparation tank :
Material : 316L stainless steel (corrosion-resistant, easy to clean), capacity from 500L to 5000L or more.
Function : Dissolve and mix API with water for injection (WFI) or other solvents.
Design features : sandwich structure (supports heating/cooling), multi-stage stirring (anchor/paddle/turbine).
· Filtration system :
Multi-stage filtration : pre-filtration (5μm) → activated carbon adsorption (optional) → 0.22μm sterilizing filtration.
Integrity test : Automatically performs a bubble point test (verifies filter membrane effectiveness).
· Conveying system :
Sanitary centrifugal pump : large flow rate for liquid medicine (avoiding damage to shear sensitive components).
Pipeline system : fully enclosed sanitary stainless steel pipeline, supporting CIP/SIP.
· Online cleaning and sterilization system (CIP/SIP) :
CIP : Multi-step cleaning (pre-rinse → alkaline wash → acid wash → final wash) to ensure no residue.
SIP : Pure steam sterilization (121 °C , 30 minutes), covering the tank, pipelines and filters.
· Control system :
PLC/SCADA integration : fully automatic control of dosing parameters (temperature, stirring speed, pH, etc.).
Data traceability : Comply with FDA 21 CFR Part 11 and record all production data (batch number, operator, alarm records, etc.).
2. Applicable Products
· Dosage form : Large volume injection (such as glucose infusion, sodium chloride infusion, amino acid infusion, blood products, etc.).
· Packaging forms : infusion bag (PVC/non-PVC), glass infusion bottle, plastic infusion bottle.
Core Functions
Functional modules | Functional Description |
Large-scale preparation | - Supports the preparation of thousands of liters of liquid medicine in a single batch to meet the needs of continuous production. |
Efficient mixing and dissolving | - Multi-stage stirring design (such as bottom magnetic stirring + side wall turbine stirring) ensures the uniformity of large volume of liquid medicine. |
Sterility protection | - 0.22μm terminal sterilization filtration, in line with the aseptic requirements of the pharmacopoeia. |
Energy-saving design | - Heat recovery system (use the residual heat of sterilization steam to preheat water for injection). |
Compliance Management | - Automatic generation of electronic batch records (EBR) to support audit trails. |
Application
· Basic infusion production : glucose, sodium chloride, compound amino acid infusion.
· Biological products : dilution and preparation of blood products such as albumin and immunoglobulin.
· Parenteral nutrition solution : homogenization of fat emulsion and vitamin compound infusion.
· Large-volume infusion of antibiotics : such as bulk preparation of cephalosporins and penicillins.
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