From Device Platform to
Commercial Manufacturing
DROFEN MACHINERY is a turnkey system provider delivering automated injection pen assembly lines and pre-filled syringe (PFS) filling systems. We deliver proven pen injector platforms, high-speed assembly equipment, and comprehensive regulatory validation support - one partner from device selection to commercial production.
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Core Capabilities
PPM Assembly Speed
Filling Accuracy
In-line Inspection
Beyond Equipment: A True System Provider
Our Integrated CDMO Approach
01 Device Platform Selection & FTO
We provide access to proven, patent-cleared pen injector platforms (disposable and reusable). Our team conducts comprehensive Freedom-to-Operate (FTO) analysis across US, EU, and key Asian markets, designing around existing patents to ensure clean market entry for your drug-device combination product.
| ISO 11608-1 | FTO Analysis | Design-Around |
02 Precision Mold & Component Manufacturing
S136 steel molds guaranteed for over 1,000,000 shots, with 32 to 64-cavity tooling and Husky/Yudo hot runner systems. Full-scale production of all pen components - pen body, dose dial, cartridge holder, needle cap - in ISO Class 8 cleanrooms with 100% dimensional inspection.
| S136 Steel | 64-Cavity | ISO Class 8 |
03 Automated Pen Pre-Assembly
High-speed pre-assembly of all mechanical pen components - dose dial mechanism, clutch, drive sleeve, and cartridge holder - using cam-driven continuous motion technology. Integrated Keyence/Cognex vision inspection at every critical station ensures zero-defect output before final assembly.
| Up to 160 PPM | Vision Inspection | Continuous Motion |
04 Drug-Device Final Assembly
Precision cartridge integration into the pre-assembled pen mechanism, followed by snap-fit locking verification, zero-position confirmation via high-resolution vision, LVDT dimensional measurement, and GS1 DataMatrix serialization. All operations in GMP Class C/D environments with 21 CFR Part 11 compliant SCADA.
| Up to 160 PPM | Zero-Position Check | 21 CFR Part 11 |
05 Aseptic Cartridge & PFS Filling
Isolator-based aseptic filling for insulin and GLP-1 therapies. Advanced ceramic pump systems achieving ±0.5% accuracy at up to 300 units per minute, with SAL 10⁻⁶ sterility assurance in ISO Class 5 / EU GMP Grade A environments compliant with EU GMP Annex 1.
| ±0.5% Accuracy | 300 units/min | SAL 10⁻⁶ |
06 Regulatory Validation & Compliance Support
We deliver complete validation documentation packages (DQ/IQ/OQ/PQ), GAMP5 computerized system validation, and regulatory submission support. Our documentation is structured to support FDA 510(k), CE MDR, and NDA filings for drug-device combination products under 21 CFR Part 4.
| DQ/IQ/OQ/PQ | GAMP 5 CSV | FDA 21 CFR Part 4 |
Core Equipment
Pen Injector Assembly
Lines
Our assembly lines are engineered for the demanding requirements of GLP-1 and insulin pen manufacturing. Featuring cam-driven continuous motion architecture, multi-stage vision inspection (Keyence/Cognex), precision force monitoring (Burster controllers), and LVDT dimensional verification - delivering 100% in-line quality assurance at production speed.
160 PPM
Pre-Assembly Speed
160 PPM
Final Assembly Speed
100%
In-line Inspection
21 CFR 11
SCADA Compliance
Aseptic Filling
Cartridge & PFS
Filling Solutions
For the primary container, we deliver isolator-based aseptic filling lines capable of processing pre-filled syringes and cartridges for insulin and GLP-1 therapies. Equipped with advanced ceramic pump systems to ensure precise dosing and the highest sterility assurance levels required for injectable drug products.
±0.5% filling accuracy across all batch sizes
Up to 300 units/min output speed
ISO Class 5 / EU GMP Grade A environment
SAL 10⁻⁶ sterility assurance level
EU GMP Annex 1 compliant isolator design
Competitive Advantages
Why Choose DROFEN as Your System Provider?
1 Partner, Full Chain
One-Stop Integration
Device platform + assembly equipment + regulatory validation from a single source. Eliminates multi-vendor coordination risk and accelerates project timelines.
Competitive TCO
Total Cost of Ownership
Leveraging our precision manufacturing ecosystem to deliver European-level quality at a highly competitive Total Cost of Ownership across the entire project lifecycle.
Accelerated Launch
Speed to Market
Proven machine platforms and ready-to-use pen designs eliminate years of device R&D. Move from project kickoff to validated production in significantly less time.
FDA + CE + ISO
Compliance Ready
Full adherence to FDA 21 CFR Part 4/11 and ISO 11608 with complete validation documentation packages structured for regulatory submission.
Comprehensive FTO
Freedom-to-Operate
Expert patent landscape analysis and design-around strategies to support clean market entry in your target jurisdictions (US, EU, and key Asian markets).
Local Teams, Global Reach
Global Support
On-site FAT/SAT execution, operator training, and dedicated technical support with local engineering teams in key markets including India.
Regulatory Excellence
Built for Global
Compliance
We don't just build equipment - we deliver complete compliance packages. Our validation documentation, process design, and regulatory support services are engineered to help your drug-device combination product pass audits on the first attempt.
COMPLIANT
COMPLIANT
COMPLIANT
FDA 21 CFR Part 4 - Combination Products cGMP
FDA 21 CFR Part 210/211 - Drug cGMP
FDA 21 CFR Part 11 - Electronic Records & Signatures
ISO 11608-1 - Needle-based Injection Systems
ISO 13485:2016 - Medical Device QMS
GAMP 5 - Computerized System Validation
EU GMP Annex 1 - Sterile Medicinal Products
ICH Q10 - Pharmaceutical Quality System
Project Delivery
Typical Project Delivery Scopes
Greenfield GLP-1 Generic Launch
Client Goal
Rapid market entry for a generic GLP-1 injectable pen product with zero prior drug-device combination manufacturing experience.
DROFEN Delivery
Patent-cleared pen device platform bundled with a 160 PPM pre-assembly line and 160 PPM final assembly line. Complete IQ/OQ/PQ execution and regulatory documentation package structured for market submission.
Outcome
Significantly reduced project timeline by eliminating years of device R&D. Single-source accountability from device selection to validated production.
Case studies are based on actual project scopes. Client names withheld under NDA.
Insulin Pen Capacity Expansion
Client Goal
Upgrade from semi-automatic assembly to fully automated production while ensuring absolute zero-position accuracy and 100% traceability.
DROFEN Delivery
Scalable indexing assembly line (up to 160 PPM) with integrated LVDT dimensional checks, multi-camera vision inspection (zero-position verification), force monitoring, and 21 CFR Part 11 compliant SCADA system.
Outcome
100% in-line quality control achieved without throughput compromise. Full electronic batch records enabling real-time release.
Case studies are based on actual project scopes. Client names withheld under NDA.
Fill-Finish to Final Assembly Integration
Client Goal
Establish a complete aseptic filling through final pen assembly process in a new GMP facility.
DROFEN Delivery
Full Turnkey Service: GMP facility layout consultation, 300 units/min aseptic filling line, seamless material transfer to 160 PPM final pen assembly, complete validation (DQ through PQ), SOPs, and operator training program.
Outcome
Operational within project timeline. Passed regulatory audit on first attempt with zero critical findings.
Case studies are based on actual project scopes. Client names withheld under NDA.
Market Entry
EU & US Market Entry
Strategies
Direct Market Entry
Build your own brand and regulatory dossier in target markets. Full control over pricing, positioning, and long-term brand equity.
Highest profit marginFull brand ownership
Long-term asset value
Distributor Partnership
Partner with established local pharmaceutical distributors who hold existing market authorizations for rapid market access.
Faster time-to-marketLower marketing investment
Shared regulatory risk
Out-Licensing
License your product IP and manufacturing rights to established pharma companies in exchange for royalties and milestone payments.
Immediate revenue streamMinimal commercial risk
Focus on R&D and production
Contact our engineering team to discuss how our turnkey CDMO approach can reduce your time-to-market and lower your total cost of ownership. Whether you are launching a new GLP-1 generic or expanding insulin pen capacity, we have the platform and expertise to support your project.