injection pen final assembly line

injection pen final assembly line

The DROFEN MACHINERY High-Speed Insulin Pen Final Assembly Line is an advanced, fully automated production system engineered to integrate pre-filled drug cartridges with pre-assembled pen bodies into finished, patient-ready injection pen devices. Designed for pharmaceutical manufacturers, CDMOs, and biosimilar producers entering the metabolic therapy market, this system delivers a stable output of 160 units per minute with 100% inline functional testing — ensuring every device leaving the line meets the strictest global regulatory standards.

As a core component of DROFEN MACHINERY's Turnkey CDMO solution, this final assembly line is not sold as a standalone machine. It is delivered as part of an integrated project that includes device platform coordination, process validation support, and regulatory documentation — eliminating the integration risks that plague traditional multi-vendor procurement approaches.

The Critical Role of Final Assembly in Injection Pen Manufacturing

In the injection pen manufacturing process, the final assembly stage is where the drug product meets the delivery device. This is the most critical step in the entire production chain because it directly affects:

•Dose accuracy — the mechanical interface between cartridge and dosing mechanism must be precisely calibrated

•Patient safety — any assembly defect can lead to under-dosing or over-dosing of insulin

•Regulatory compliance — final assembly is the last point of intervention before the device reaches the patient, making it subject to the most rigorous GMP scrutiny

Unlike pre-assembly (which handles plastic component assembly), final assembly must operate under controlled cleanroom conditions and integrate real-time quality verification at every station. This is why choosing the right final assembly equipment partner is a strategic decision, not merely a procurement decision.

Technical Specifications

Parameter
Specification
Production Speed
160 units/min (stable continuous output)
Compatible Pen Types
Disposable insulin pens, reusable insulin pens, GLP-1 pens, autoinjector pens
Cartridge Compatibility
1.5 mL, 3.0 mL standard cartridges
Dose Setting Range
0.5 IU – 80 IU (configurable per device platform)
Cleanroom Requirement
ISO Class 7 (Class 10,000) or better
Inline Testing
100% functional testing including dose accuracy, button force, needle attachment force, and visual inspection
Rejection Rate
< 0.3% (typical operating condition)
Changeover Time
< 45 minutes between pen variants
Line Length
Approximately 18 meters (configurable)
Power Supply
380V/50Hz, three-phase (adaptable to local standards)
Control System
Siemens S7-1500 PLC with HMI touchscreen interface
Data Management
21 CFR Part 11 compliant electronic batch records
OEE Target
≥ 85% under standard operating conditions




Key Assembly Stations

The DROFEN final assembly line consists of the following integrated stations, each performing a specific function in the assembly sequence:

Station 1: Cartri