Marya Fully Automated Aseptic Prefilled Syringe Filling Line
with Isolator Technology
Product Description
The Marya Fully Automated Aseptic Prefilled Syringe Filling Line integrates advanced isolator technology to ensure the highest level of sterility and compliance with GMP, FDA, and EU regulations. Designed for precision and efficiency, this state-of-the-art system features fully automated filling, stoppering, and capping processes, minimizing human intervention and contamination risks. Equipped with high-speed servo-driven pumps, it ensures accurate dosing for a wide range of biologics, vaccines, and sensitive pharmaceuticals. The closed isolator system maintains ISO 5 cleanliness, while integrated vision inspection and leak testing guarantee product integrity. With easy changeover capabilities and SCADA-based controls, the Marya line enhances productivity while reducing downtime-ideal for large-scale aseptic manufacturing. Reliable, scalable, and future-ready, it sets the benchmark for sterile prefilled syringe production.
Key Features:
- Compliance: Ensures full adherence to the latest GMP and FDA requirements for pharmaceutical manufacturing.
- Versatility: Suitable for glass or plastic bottles ranging from 1ml to 50ml, customizable based on user specifications.
- Efficiency: Capable of processing 300-3000 bottles per hour, with 1-4 filling heads selected according to production needs.
- Precision: Offers ±1% filling accuracy, determined by the characteristics of the medicine.
- Sealing Options: Includes screw capping, rolling capping, or thread-rolling capping techniques.
- Quality Assurance: Ensures a product qualification rate of ≥99.9%.
- User-Friendly Operation: Equipped with an intuitive interface, simple structure, stable performance, and precise dosing.
- Advanced Technologies: Incorporates servo motor control for high-precision filling, nitrogen filling units for oxygen isolation, and an Open-RABS isolation protection system alongside a class 100 laminar flow air purification system for contaminant-free production.
Customizable Options:
- CIP/SIP System: Configurable filling system for enhanced cleaning and sterilization.
- Nitrogen Filling Unit: Isolates the liquid from oxygen during filling.
- Vacuum Filling System: Ideal for high viscosity products.
- Open-RABS Isolation System: Provides additional protection with a class 100 air purification laminar flow system.
- Automatic Calibration: Features automatic filling volume correction for pumps.
Technical Specifications:
| Feature |
Description |
| Compliance |
Meets GMP and FDA standards for pharmaceutical production |
| Servo Control System |
Automated process control for stability and efficiency |
| Applicable Specification |
1ml-20ml vials (customizable based on user requirements) |
| Filling Range |
0.1ml-20ml |
| Production Capacity |
2000-30000 vials per hour |
| Filling Heads |
2-10 (selectable based on production needs) |
| Filling Pump Options |
Metal, peristaltic, ceramic pumps |
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