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Infinity Biotechnology offers comprehensive turnkey solutions for the production of both standard and prefilled syringes. Designed in accordance with GMP, ISO 13485, and CE regulations, our systems encompass equipment design, cleanroom integration, mold manufacturing, process validation, and regulatory documentation.

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Syringe Production Systems

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INFINITY SYRINJECT-PRO®

Fully Automated High-Capacity Syringe Production Line

Engineered for industrial-scale manufacturing, the SYRINJECT-PRO® system ensures continuous and reliable production of sterile and prefilled syringes with minimum human intervention.

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Key Features:

• Robotic syringe barrel feeding and plunger insertion

• Precision vacuum-based liquid filling with de-bubbling

• Stopper insertion and alignment with position accuracy

• Vacuuming and venting systems with programmable parameters

• In-line 100% inspection with auto-rejection

• Automated tray loading, denesting, and labeling systems

• PLC/SCADA-based control with data logging

• Cleanroom-compliant configuration (ISO Class C/D)

 

Production Capacity:        Up to 24,000 syringes per hour
Supported Formats:         1 ml, 2.25 ml, 3 ml, 5 ml, 10 ml, 20 ml (glass or plastic)

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INFINITY SYRINJECT-FLEX®

Semi-Automated Syringe Assembly and Filling Line

SYRINJECT-FLEX® is a modular and cost-effective system designed for mid-scale production facilities, startups, or R&D units requiring flexibility and compact configuration.

Key Features:

• Manual or semi-automated syringe loading

• Vacuum-assisted or time-controlled liquid filling

• Manual plunger and stopper placement

• Desktop-based labeling and manual tray handling

• Compact footprint for limited space cleanroom areas

• Easily upgradable to a fully automated version

 

Production Capacity            : 3,000 to 5,000 syringes per hour
Configuration                       : Skid-mounted modular design

 

MOLD-SYNC® – Plastic Injection & Tooling Division

In addition to syringe assembly systems, Infinity Biotechnology provides integrated plastic injection and mold design services to support in-house production of syringe barrels, plungers, and related components.

• Multi-cavity mold design and validation

• Compatible with medical-grade materials such as PP, PE, PET, HDPE

• Turnkey injection molding machines with servo/hybrid systems

• Peripheral unit integration (chillers, dryers, loaders)

• Complete IQ/OQ/PQ documentation for CE and ISO 13485 compliance

With MOLD-SYNC®, manufacturers gain full control over component quality and supply chain continuity.

 

System Comparison Overview

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                                                           SYRINJECT-PRO®                     SYRINJECT-FLEX®

Production Scale                         High-volume, industrial             Mid-volume, scalable

Filling Method                             Vacuum + precision pump        Vacuum-assisted or manual

Stopper/Plunger Insertion          Robotic                                       Manual or pneumatic-assisted

Inspection                                    In-line, automatic                       Manual or visual

Tray Packaging                            Automated                                 Manual

Automation Level                       PLC/SCADA                                Basic HMI or manual control

Injection Molding Integration   Included via MOLD-SYNC®      Included via MOLD-SYNC®

Regulatory Support                   CE, ISO13485,GMP compliant   CE, ISO 13485, GMP scalable

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Regulatory and Validation Support

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• CE Technical File development

• Design documentation aligned with ISO 13485

• DQ / IQ / OQ / PQ validation protocols

• Process risk analysis and FMEA

• Operator training, FAT/SAT execution, post-installation service

 

Why Infinity Biotechnology

• Full-scope delivery: from molds to automation and regulatory guidance

• Flexible models for both industrial-scale and mid-scale production

• Deep experience in diagnostics and medical device manufacturing

• Single point of contact for equipment, validation, and compliance

• Scalable solutions designed for global deployment and long-term ROI