New Application
Saline Flush Syringe (PFS) - Full Automated Production Line
DROFEN MACHINERY delivers a complete turnkey pre-filled syringe production line for 0.9% NaCl saline flush syringes in PP format. From sodium chloride solution preparation and mold development to aseptic filling, AI-powered light inspection, plunger rod insertion & labeling, and pillow packaging - all 6 stations integrated into one seamless automated system at 220 syringes per minute.
NaCl Solution Prep; PP Mold Development; Aseptic Filling; AI Light Inspection; Plunger Rod Insertion;
Pillow Packaging; GMP Compliant; CDSCO · SFDA Ready
Machine Line
Turnkey Production Line
220
syr/min
6
Stations
ISO 5
Cleanroom
>85%
OEE
Insulin Pen Device - Full Turnkey CDMO Solutions & applications
Insulin Pen Device
Industrial Design & Patent FTO Strategy
From Concept to IP-Protected Product
DROFEN provides end-to-end industrial design services for insulin injection pens, covering ergonomic UX, ISO 11608-1 compliance, 3D prototyping, and comprehensive Freedom-to-Operate (FTO) analysis across the US, EU, and Asian markets. Our design-around strategies ensure clean market entry with zero IP risk.
Design Cycle
8–12 weeks
Patent Databases
USPTO, EPO, CNIPA
Markets Covered
US, EU, India, LATAM
| ISO 11608-1 | FTO Analysis | 3D Prototyping | USPTO / EPO |
Enquire Now> View Equipment >
Precision Tooling
High-Precision Injection Mold Development
Medical-Grade Tooling for All Pen Components
Our tooling division manufactures S136 stainless steel molds with guaranteed service life exceeding 1,000,000 shots. Supporting 32–64 cavity configurations with Husky/Yudo hot runner systems, all production is conducted in ISO Class 8 cleanrooms. Mold flow analysis (Moldex3D/Moldflow) is standard for every project.
Mold Life
≥1,000,000 shots
Cavity Range
32 – 64 cavities
Lead Time
45 – 60 days
| S136 Steel | 64-Cavity | Mold Flow Analysis | ISO Class 8 |
Enquire Now> View Equipment >
Component Manufacturing
Insulin Pen Component Injection Molding
Full-Scale GMP Production of All Pen Parts
DROFEN operates dedicated GMP cleanroom injection molding lines for all insulin pen components - pen body, dose dial, cartridge holder, needle cap, and clip. Medical-grade PP/ABS/PC resins with 100% dimensional inspection, full material traceability, and ISO 13485-certified quality management.
Components
8+ pen parts
Resin Grade
USP Class VI
Inspection
100% CMM + Vision
| Medical PP/ABS/PC | 100% Inspection | ISO 13485 | GMP Cleanroom |
Enquire Now> View Equipment >
Sterile Drug Filling
Aseptic Filling - Insulin & (GLP-1)
Isolator-Based Sterile Fill-Finish for Cartridges & PFS
Our isolator-based aseptic filling lines support insulin (U-100/U-200/U-300), , , and other GLP-1 drugs in 1.5 ml / 3 ml glass cartridges and pre-filled syringes. Ceramic pump technology achieves ±0.5% fill accuracy at speeds up to 600 CPM, with full CIP/SIP automation and 21 CFR Part 11 data integrity.
Fill Speed
Up to 600 CPM
Accuracy
±0.5% (CV)
Container
1.5 ml / 3 ml cartridge, PFS
| Isolator Technology | ±0.5% Accuracy | 600 CPM | SAL 10⁻⁶ |
Enquire Now> View Equipment >
Assembly Automation
Automated Insulin Pen Assembly Line
High-Speed Continuous Motion Assembly with Vision Inspection
DROFEN's cam-driven continuous motion assembly systems achieve 60–300 PPM output for disposable and reusable insulin pens. Integrated Keyence/Cognex vision inspection validates every unit for dimensional conformance, torque, and click-force. SCADA with 21 CFR Part 11 audit trail is standard on all lines.
Output Speed
60 – 300 PPM
Inspection
100% Vision + Torque
Compliance
21 CFR Part 11 SCADA
| 60–300 PPM | Vision Inspection | Torque Testing | 21 CFR Part 11 |
Enquire Now> View Equipment >
Drug-Device Combination
Drug-Device Final Assembly & Serialization
Cartridge Integration, Track & Trace, Cold-Chain Packaging
The final assembly stage integrates filled drug cartridges into completed pen devices with precision snap-fit locking, GS1 DataMatrix 2D serialization, and cold-chain ready secondary packaging. All operations are performed in GMP Grade C/D environments with full batch record documentation.
Serialization
GS1 DataMatrix 2D
Environment
GMP Grade C / D
Packaging
Cold-chain 2–8°C ready
| GS1 DataMatrix | Track & Trace | Cold Chain | GMP Grade C/D |
Enquire Now> View Equipment >
Regulatory & Compliance
GMP / FDA Compliance & Regulatory Support
Full Validation Documentation & Submission Assistance
DROFEN delivers complete validation packages (DQ/IQ/OQ/PQ) and GAMP5 Computer System Validation (CSV) for all equipment. Our regulatory team provides hands-on assistance with FDA 510(k), NDA/ANDA submissions, CE MDR technical files, and EU Annex 1 compliance assessments. We support clients in the US, EU, India, and emerging markets.
Validation
DQ / IQ / OQ / PQ
Markets
FDA, CE, CDSCO, ANVISA
Documentation
Full URS + VMP Package
| ISO 13485 | EU MDR / Annex 1 | FDA 510(k) | GAMP5 CSV |
Enquire Now> View Equipment >
Market Expansion
Global Market Entry - US, EU & Emerging Markets
Turnkey Support for International Pharmaceutical Registration
Beyond equipment supply, DROFEN acts as your strategic partner for global market entry. We provide GMP facility audit support, regulatory gap analysis, local distributor network introductions, and post-market surveillance frameworks. Our installed base spans India, Southeast Asia, the Middle East, and Latin America.
Installed Base
12+ countries
Audit Support
FDA, WHO, EU GMP
Service
On-site commissioning
| GMP Audit | Market Access | Distributor Network | Post-Market |
Enquire Now> View Equipment >
Ready to Start Your Insulin Pen CDMO Project?
Contact our engineering team today for a free project assessment, equipment quotation, and regulatory roadmap tailored to your target market.