Marya Sanitary 316L Stainless Steel Liquid Preparation System for GMP Sterile Pharma

Product Description

Marya Sanitary 316L Stainless Steel Liquid Preparation System for GMP Sterile Pharma

Introduction

The Maya Pharmaceutical Formulation System is a precision drug preparation equipment designed for the mixing and dispensing of liquid pharmaceuticals. It enables the controlled addition of active pharmaceutical ingredients into solvents such as Water for Injection (WFI), followed by homogenization through stirring, heating, sterilization, and filtration processes to achieve the desired drug concentration.

This system is widely used in both sterile and non-sterile pharmaceutical manufacturing, including applications in biopharmaceutical production, large-volume parenteral (LVP) solutions, and other critical drug formulation processes.

Classification

1. General Formulation System

   • For small-molecule chemical prep (e.g., aqueous injections, lyophilized powder injections).

2. Complex Formulation System

   • Handles advanced processes: suspensions, emulsions, liposomes, microspheres.

3. Biological Formulation System

   • For biotech products (antibodies/vaccines/blood products/recombinant proteins) & auxiliary liquids (media/buffers).

Core Advantages

1) Modular Design - Cost-Saving & Efficient

• Pre-tested modular equipment reduces installation costs, accelerates delivery, and ensures flexibility.
  

2) Fully Automated Operation - Smart & Compliant

• 1-click CIP/SIP with auto-detection for cleaning/sterilization completion.

• Computerized features: Recipe management, e-signature, e-records, and audit trail for full automation.
  

3) Process Control & Real-Time Monitoring

• Critical parameter control (temp, DO, pH) with auto-alerts for deviations to ensure drug quality.
  

4) 3D Simulation & Ergonomic Layout

• Pre-production 3D modeling optimizes piping, valve, and instrument placement for user-friendly operation.
  

Design Features

1. Premium Material & Compliance

   • 316L stainless steel tanks (2L-12,000L) with electrolytic polishing (Ra<0.4µm), ensuring cleanability and compliance with EU PED & FDA standards.

   • FDA-compliant connections (clamps/NA) and seals (EPDM/PTFE), with PTFE gaskets for jacket nozzles.

2. Sterility Assurance

   • Sterile ventilation/exhaust filters and CIP spray balls for aseptic operations.

   • Optional sterile double-tube plate heat exchanger for WFI cooling and filter integrity testing.

3. Safety & Control Systems

   • Integrated safety devices (burst disc/safety valve + pressure gauge) for equipment/personnel protection.

   • Precision temperature (bottom probe) and pressure (top probe) monitoring with automated controls.

4. Efficient Mixing & Heat Transfer

   • Magnetic stirrer (bottom, electromagnetic-driven) or mechanical stirrer (top), both with variable frequency speed regulation.

5. Accurate Material Handling

   • Weighing/liquid-level detection for controlled water addition and material feeding.

6. High-Performance Filtration

   • Sterilization-grade PES filters (pH 1-14, 150°C resistant) with organic solvent compatibility and reliable bacterial retention.

7. Operational Visibility

   • Illuminated sight glasses for real-time level monitoring.

Product Parameters

Name	Parameters
Working volume	2~15000L
Material	304, 316L, 904L, TA2
Stirring type	Upper mechanical, lower magnetic stirring
Stirring speed control accuracy	Speed range 0~450rpm  ±3.0%
Temperature control accuracy	Temperature range-10~150ºC ±0.2ºC
Pressure control accuracy	Pressure range-0.01Mpa~0.06Mpa ±0.01MPa
Weighing control accuracy	3‰
Power supply	380V 50Hz (Note: Other voltages require a transformer)
Sealing and protection levels	IP65

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