Marya Aseptic Filling Production Line Isolator System for Pharmaceutical Injection Prefilled Syringes/Ampoules/Oral Liquids/Vials Filling Line

Customization: Available
After-sales Service: Video Online, Field Installation
Warranty: 1 Year

Product Description

Basic Information
Model NO.
MY-isolator
Type
Volumetric Filling Machine
Automatic Grade
Fully Automatic
Material Type
Liquid
Filling Valve Head
Multi-Head
Structure
Rotary
Compliance
GMP
Material
Stainless Steel
Product Description

Aseptic filling production line isolator system for pharmaceutical injection prefilled syringes/ampoules/oral liquids/vials filling line

The pharmaceutical industry isolator filling production line meets strict pharmaceutical production quality management standards (GMP) requirements. It features extremely high requirements for sterility, accuracy, and reliability, equipped with high-precision filling equipment, strict sterilization systems, and complete monitoring systems.

Filling Production Line
Production Unit 1 Production Unit 2
Key Features
  • Highly Sterile: Completely isolated with HEPA filtered air exchange and automatic VHP sterilization.
  • Pressure Stability: Maintains internal positive pressure to prevent unfiltered air entry.
  • Transfer Safety: Uses double doors or rapid transfer systems (RTP) for sterile material handling.
  • Man-Machine Separation: Operators work via glove ports, reducing contamination risks.
  • Intelligent Monitoring: Real-time tracking of temperature, humidity, pressure, and particle concentration.
  • GMP Compliance: Design, materials, and assembly meet the latest pharmaceutical specifications.
Feature Details
Technical Specifications
Monitoring System Online checking of pressure, temperature, humidity, and clean grade. Complying with GMP/GLP.
Control System PLC Automated Control
Sterilizer Type Ozone sterilization or VHP (Vaporized Hydrogen Peroxide) Sterilization
VHP Residue < 1 PPM (based on technological requirements)
Chamber Sealing Leakage rate ≤ 5% within 10 minutes at 500 Pa pressure
Workshop & Manufacturing
Detailed Workflow Workshop View
Certificates & Projects
Certificates Project Case
Customer & Exhibition
Our Customers
Exhibition 1 Exhibition 2
Packaging & Shipping
Shipping Details
Frequently Asked Questions (FAQ)
1. What type of sterilization is used in the isolator? The system can adopt either Ozone sterilization or VHP (Vaporized Hydrogen Peroxide) sterilization, depending on specific pharmaceutical requirements.
2. Does the equipment comply with international standards? Yes, the machine design, materials, and manufacture meet the latest GMP pharmaceutical production specification requirements.
3. How is the air purity maintained inside the cabin? The isolator is completely isolated from the outside. Air exchange occurs only through High-Efficiency Particulate Air (HEPA) filters to prevent contamination.
4. What is the leakage rate of the isolator chamber? The chamber leakage rate is strictly controlled and does not exceed 5% within 10 minutes under a pressure of 500 Pa.
5. What parameters can be monitored in real-time? The online monitoring system tracks internal pressure, temperature, humidity, wind speed, and suspended particle concentration.
6. Is the system customizable for different dosage forms? Yes, the modular design allows for customization for various forms, including injection filling, oral liquids, ampoules, and vials.

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