Marya GMP FDA Certificated Aseptic RTU Pfs Syringe Vial Cartridge Filling and Stoppering Line with Easy Maintenance

• Customization: Available
• After-sales Service: Video Online; Filed Installation
• Warranty: 1 Year
• Type: Volumetric Filling Machine
• Automatic Grade: Automatic
• Material Type: Liquid
• Filling Valve Head: Multi-Head
• Feed Cylinder Structure: Multi-Room Feeding
• Dosing Device: Rotor
• Filling Principle: Pressure
• Packaging Container Lifting Structure: Customized
• Structure: Rotary
• Packaging: Syringe
• Packaging Material: Glass or Plastic
• Isolator: Optional
• Rejected System: Equipped
• Flow Sensor: Equipped
• CIP/SIP System: Optional
• Industry Computer: Realize Part 11
• Electrical Control Program: Equipped
• Filling Accuracy: 99%
• Capacity: 50-200PCS/Min
• Pump: Ceramic, Stainless Steel
• Buffer Bin: Optional
• UPS: Optional
• Syringe Sorting System: Optional
• Electric Power: 230V 3 Phase
• Air Velocity: 0.45m/S
• Filling Volume: 5ml-10ml
• Transport Package: Export Wooden Cases
• Specification: 1200*800*1800
• Trademark: Marya
• Origin: China
• Package Size: 350.00cm * 200.00cm * 200.00cm
• Package Gross Weight: 300.000kg

Product Description

Marya GMP FDA Certificated Aseptic RTU PFS Syringe Vial Cartridge Filling and Stoppering Line with Easy Maintenance  

 

Overview

The pre-filled syringe filling and stoppering production line is designed for sterile filling of RTU containers including pre-filled syringes, vials, and cartridges. This automated system performs complete processing steps from unpacking to filling and stoppering, serving critical needs across pharmaceutical, cosmetic medicine, and healthcare industries.

This precision equipment handles small-dose formulations with exceptional accuracy, making it ideal for vaccines, biologics, antithrombotic medications, and cosmetic injectables. By maintaining strict isolation from external environments, the system effectively prevents product contamination while enhancing production efficiency. The resulting pre-filled units offer significant advantages in clinical settings by simplifying administration and ensuring dosing accuracy.

Performance Features

1. High Precision: Equipped with a high-precision ceramic plunger pump for accurate dosage control.
2. Efficiency: Caters to various production needs with capabilities ranging from medium to high-speed operations.
3. Sterile Operation: Maintains a sterile environment throughout the filling and stoppering process to prevent contamination.
4. Intelligent Control: Features automatic monitoring and easy operation for seamless production.
5. Wide Application: Compatible with a variety of drugs and RTU packaging materials.
6. Regulatory Compliance: Meets GMP, FDA 21CFR part 11, and other regulatory requirements.
7. Easy Integration: Seamlessly integrates with other production line equipment for a complete system.
8. Modular Design: Allows for easy upgrades and adaptability to various packaging materials.
9. Easy Maintenance: Designed for easy disassembly and cleaning, reducing maintenance costs.
10. Flexible Production Modes: Supports single batch and continuous production to meet diverse needs.
11. Intelligent Operation: Adjustable filling volume and stoppering depth with individual servo motor control.
12. Safety: Includes stopper missing detection and various overload protection alarms.
13. Traceability: Records key production data for quality control and traceability.
14. Versatile Filling Systems: Offers multiple filling systems to accommodate different liquid characteristics.

 

Optional Configurations

• Nitrogen Filling System: For antioxidant requirements during filling and storage.
• Vacuum Filling and Stoppering Mode: on-damaging and suitable for various types of rubber stoppers.
• Expandable Laminar Flow: Protects product and packaging under class A clean environment.
• PMS Online Monitoring System: Real-time sterile production environment monitoring with data traceability.
• Online Sterilization Plunger Pump: For CIP/SIP functionality of the filling system.

Product Parameters

 

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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