Marya Pharmaceutical High-Precision Prefilled Syringe Filling Line with ISO Class 5 Clean Standard

• Customization: Available
• After-sales Service: Video Online; Filed Installation
• Warranty: 1 Year
• Type: Piston Filling Machine
• Automatic Grade: Fully Automatic
• Material Type: Liquid
• Filling Valve Head: Multi-Head
• Feed Cylinder Structure: Multi-Room Feeding
• Dosing Device: Plunger
• Filling Principle: Pressure
• Packaging Container Lifting Structure: Servo Motor
• Structure: Linear
• Packaging: Barrel
• Packaging Material: Metal
• Capacity of Production: 2,000-30,000 Bottles Per Hour
• Application: Monoclonal Antibody; Vaccine; Hyaluronic Acid
• Driven Type: Electric
• Machine Power: 4.1kw
• Filling Volume: 0.1-20ml
• Canned Head: 2-10
• Filling Accuracy: ≤1%
• Us Filling Choice of Various Pumps: Ceramic Pump, Metal Pump, Peristaltic Pump,
• Isolation Protection System: Open-Rabs
• System: Isolator or Bibo
• Auto Stoppering Rate: ≥99.9%
• Transport Package: Inner Water Proof Bag, Outer Sea Worth Case
• Specification: 3800*2500*2500
• Trademark: Marya
• Origin: China
• Package Size: 200.00cm * 150.00cm * 180.00cm
• Package Gross Weight: 300.000kg

Product Description

Marya Pharmaceutical High-Precision Prefilled Syringe Filling Line
with ISO Class 5 Clean Standard

 

Introduction
 

The Prefilled Syringe Filling Machine is a fully automated system designed for high-precision and sterile filling of prefilled syringes (PFS), cartridges, and vials. It is widely used in the pharmaceutical and biotech industries for sensitive applications such as vaccines, biologics (e.g., monoclonal antibodies, ADCs), and high-value injectables (e.g., insulin, cell therapies).

Applications:
Vaccines: mRNA vaccine filling

Biologics: monoclonal antibodies, ADC drugs

High-Value Drugs:  cell therapy products

Performance Features

1. Ultra-Precise Dosing: Achieves ±1% filling accuracy, with minimum fill volumes as low as 0.1mL, ensuring consistent drug delivery.
2. Sterility Assurance: Operates in an ISO 5 (Class 100) clean environment, with optional VHP (Vaporized Hydrogen Peroxide) sterilization for aseptic processing compliance.

3. Flexible Compatibility: Supports prefilled syringes, cartridges, and vials with quick changeover capabilities.

4. End-to-End Automation: Performs feeding, filling, stoppering, capping, and inspection in a single integrated system, minimizing human intervention.

Core Technology

• Precision filling pumps (peristaltic or piston type) with anti-drip design

• Optional isolator for OEB5 level containment

• Vision inspection system for missing containers, fill level, and particulate detection

• PLC+HMI control system with FDA 21 CFR Part 11 compliant data tracking

 

Adantages

• Closed system design minimizes contamination risk

• High production capacity up to 30,000 units/hour

• Complies with GMP and EU Annex 1 requirements

The system can be customized with additional modules such as lyophilization or nitrogen protection as needed.

Product Parameters

 

Suitable Product Range	0.1-20ml change specification parts properly
Power Supply	380V 50Hz
Power	4.1kw
Filling Error	±1%
Compressed Air Pressure	0.6~0.8Mpa 20m³/h
Auto Stoppering Rate	≥99.9%
Single Machine Noise	≤70db
Weight	750kg
Dimension	1630×1320×1700(mm)

Successful Prefilled Syringe Filling Line Case

We did a successful prefilled syringe filling line in Malaysia. Malaysia client wanted to find a supplier who could integrate all resources. Other suppliers cannot provide a one stop solution. Only Marya can meet all the needs of clients and provide them with professional technical guidance.

 

About client: A listed pharmaceutical company in Malaysia.

Client needs: Plastic pre-filled syringe aseptic isolator filling production line and packing line.

Solution:The client wanted to find a supplier who could integrate all resources. Other suppliers cannot provide an one stop solution that can integrate high-capacity plastic pre-filled syringe fillingmachines (with CIP/SIP systems), isolators, screw rod labeling machines, packing lines, etc. In the end, only Marya can meet all the needs of clients and provide clients with professionaltechnical guidance, so the client finally chose our company to provide them with a time-saving and worry-free one-stop solution.
Plastic pre-filled syringe isolator filling line and packaging line:
Bottle size: 5ml, 10ml
Capacity: 10ml, 12000pcs/h
Equipment composition (6 sets in total): Orabs + syringe elevator +syringe centrifugal finishing machine + pre-filled syringe filling machine + Isolator + sterilization tray machine +screw rod labeling machine + pillow packaging machine + soft blister packing machine+light inspection machine

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