Product

Oral Liquid Solution Preparation System

Functions

The oral liquid solution preparation system is a set of specialized equipment designed for precise solution preparation and refining of oral liquids. As oral liquids are sterile or semi-sterile fluids, the system is required to have a hygienic and clean design, enabling cleaning and sterilization, accurate metering, agitation for solution preparation, and aseptic filtration, among other functions.

Features

1.Compliance with International Standards

The system is designed in accordance with the latest national GMP, EU CGMP, US FDA standards, and other regulatory requirements, ensuring stable product performance through standardized design.

2. Fully Automated and Multifunctional Operation

  • Unmanned Operation: Enables fully automated solution preparation to prevent errors like under-dosing or over-dosing.
  • Real-time Monitoring: Monitors the entire process (feeding, proportioning, agitation, sterilization) with dynamic display, real-time recording of production parameters, and data transmission.
  • Integrated Functions: Supports mobile solution preparation, aseptic preparation, agitated mixing, and weighing-based dosing, serving as a multifunctional integrated system.

3. Hygienic Design and Premium Materials

  • Sanitary Construction: Manufactured from high-quality hygienic stainless steel, with polished surfaces, 死角 – free (dead angle-free) structures for easy cleaning and sterilization.
  • Premium Components: Key components (tanks, pumps, heat exchangers, filters, valves, pipelines, instruments) are sourced from international and domestic leading brands, ensuring aesthetic design and superior quality.

4. Comprehensive Validation and On-site Configuration

  • Customizable Installation: Supports on-site configuration of clean utility systems and aseptic process pipelines.
  • Regulatory Compliance: Validation processes strictly follow GMP and GAMP5 standards, providing clients with validation scheme development, implementation, and related services to ensure full traceability of all documents.

5. System Component Composition

The system comprises:
  • Cylinder body and head
  • Jacket or coil pipe (for heating/cooling circulation)
  • Agitators (anchor type, paddle type, turbine type, magnetic stirring, etc.)
  • Transmission device (motor-reducer)
  • Sealing device
  • Metering device
  • Thermal insulation medium
  • Filters and pumping equipment

Key Validation Issues

1. Heating Performance Validation

2. Cooling Performance Validation

3. Cleaning Performance Validation

4. Pressure Retention Performance of Solution Tank

5. Agitation Speed, Intensity, and Uniformity Validation

6. Metering System Validation

7. Temperature Detection System Validation

 

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