Company Profile

DROFEN MACHINERY is a turnkey system provider delivering automated injection pen assembly lines and pre-filled syringe (PFS) filling systems. We deliver the injection pen device and the assembly equipment as one integrated system - every process parameter is pre-validated as a matched pair, eliminating months of compatibility testing and multi-vendor coordination risk.

Founded in 2009 and headquartered in Shanghai, DROFEN MACHINERY serves CDMOs, biosimilar companies, and pharmaceutical manufacturers scaling up GLP-1 and insulin injectable production across India, Southeast Asia, the Middle East, and Latin America.

Two Core Turnkey Production Lines

DROFEN MACHINERY delivers two integrated turnkey production line systems. Our role extends beyond equipment supply - we provide the complete system including pen device platform, high-speed assembly equipment, and full regulatory validation as one integrated delivery.

1. Injection Pen Assembly Lines - Up to 160 Pens/Min

High-speed automated assembly lines for disposable and reusable pen injectors (insulin pens, GLP-1 pens, autoinjectors). Our cam-driven continuous-motion architecture with 130-pallet transport achieves 160 pens per minute. Integrated Keyence/Cognex multi-camera vision inspection and Burster/Kistler force-displacement monitoring ensure 100% inline quality verification on every single pen.

Turnkey deliverables:

• Pre-assembly equipment - cartridge insertion, mechanism integration, 8-13 component handling, vibratory bowl feeding, RFID pallet tracking, up to 160 PPM

• Final assembly lines - labeling, 100% inline functional testing (dose accuracy, injection force), packaging, up to 160 PPM

• Pen device platform - certified injection pen designs (disposable & reusable) matched to our assembly equipment, with FTO analysis and regulatory dossier

• Vision & force monitoring - Keyence/Cognex multi-camera inspection + Burster/Kistler force-displacement verification, 100% inline, zero sampling

• Complete validation package - DQ/IQ/OQ/PQ documentation, Challenge Parts protocol, 21 CFR Part 11 compliant SCADA, GAMP5 CSV

2. Pre-Filled Syringe (PFS) Filling Lines - 220 Syringes/Min

Complete 6-station turnkey production lines for PP saline flush syringes at 220 syringes per minute. From NaCl solution preparation through aseptic filling (±0.5% accuracy), AI-powered light inspection (99.5% detection rate, ≥50 µm), serialization, to final pillow packaging - all integrated under one validated system with contractual >85% OEE guarantee.

6-station integrated process:

• Station 1: NaCl solution preparation - WFI-based, 0.22 µm sterilizing-grade filtration, automated CIP/SIP

• Station 2: Syringe mold development & component supply - S136 steel, USP Class VI, ISO Class 7 molding environment

• Station 3: Aseptic filling & stoppering - peristaltic/rotary piston dosing, ±0.5% accuracy, ISO Class 5 isolator, 100% IPC weight check

• Station 4: AI-powered light inspection - deep learning algorithms, 99.5% detection rate (≥50 µm), 40% fewer false rejects vs. traditional systems

• Station 5: Plunger rod insertion & serialization - GS1 DataMatrix, EU FMD, CDSCO, SFDA, FDA DSCSA compliant

• Station 6: High-speed pillow packaging - 220 packs/min, N₂ flush option, 100% seal integrity verification

Why Choose DROFEN MACHINERY as Your Turnkey System Provider?

Ready to Launch Your Injectable Production Project?

Whether you are a CDMO entering the GLP-1 pen market, a biosimilar company launching a generic insulin pen, or a pharmaceutical manufacturer scaling up from semi-automatic to fully automated production - DROFEN MACHINERY delivers the complete turnkey system to get you from concept to commercial launch.

Contact DROFEN MACHINERY

Global Presence

 

Headquartered in Shanghai with dedicated local teams in key markets.

Installed base spans India, Southeast Asia, the Middle East, and Latin America. On-site FAT/SAT execution, operator training, and ongoing technical support available in all served regions.

Regulatory Standards Supported

 

• FDA 21 CFR Part 4 - Combination Products cGMP

• FDA 21 CFR Part 11 - Electronic Records & Signatures

• ISO 11608-1 - Needle-based Injection Systems

• ISO 13485:2016 - Medical Device QMS

• EU GMP Annex 1 (2022) - Sterile Medicinal Products

• GAMP 5 - Computerized System Validation

• ICH Q10 - Pharmaceutical Quality System

• USP <790> - Visible Particulates in Injections