Name: Insulin Pen Pre-Assembly Machine & Sub-Assembly Equipment | 160 PPM Cam-Driven – DROFEN
Brand: DROFEN
SKU: 287345148

Description

Technical Parameters

INJECTION PEN PRE-ASSEMBLY SYSTEM

ULTRA-HIGH-SPEED CORE MECHANISM ASSEMBLY PLATFORM | 5-CELL MODULAR ARCHITECTURE

160

PARTS / MIN

≥85%

TARGET OEE

≥98%

PRODUCT YIELD

≥1.33

Cpk

Technical Specifications

System Architecture	5 Independent Cells + Palletizing Unit \| 12 Precision Stations per Cell
Components Processed	13 micro-components per pen mechanism
Servo Axes	26 multi-axis servo motors (Bosch Rexroth)
Force / Torque Monitoring	KISTLER load cells \| 100% force-displacement curve per unit
Dimensional Inspection	Keyence LVDT + Vision \| 1–10 μm measurement accuracy
Injection Force Test	330 mm/s stroke \| 10.0 N ± 1.0 N acceptance window
MTBF / MTTR	≥ 8 hours / ≤ 2 minutes
Autonomous Operation	2 hours continuous without operator intervention \| Max 3 operators
Changeover	10 recipe-driven points \| No mechanical tooling change
Tooling Durability	< 0.05 mm wear over 5-year service life at 160 PPM
Noise Level	< 75 dB(A) at 1 m
Palletizing	12 × 20 = 240 pcs/tray \| Automatic batch separation

Control Platform & Compliance

PLC	Siemens S7-1500 (CPU 1517-3PN/DP) \| TIA Portal V19
HMI	Advantech PPC-618W industrial panel (bilingual)
Network	Profinet real-time \| OPC-UA for MES/SCADA integration
Cam Control	32 Global Cams + 32 Cell Cams \| Absolute encoder (0–359°)
Data Integrity	21 CFR Part 11 \| 5-element audit trail \| 99+ user accounts \| PDF export
Validation	GAMP 5 V-model \| FAT (IT/OT/Run) \| SAT \| IQ/OQ/PQ \| RTM
Safety	CE 2006/42/EC \| ISO 13849 PL-d interlocks \| E-stop < 0.5 s
Source Code	Open architecture - PLC/HMI/Vision code delivered without password protection

5-Cell Assembly Process

01/

Cell 1 - Loading & Vision: Component feeding with Keyence orientation verification. Lead screw direction confirmed before entry.

02/

Cell 2 - Sub-Assembly: Precision insertion with LVDT height measurement. Dimensional accuracy: 1–10 μm.

03/

Cell 3 - Consolidation: Rotor rib / bushing slot alignment. LVDT continuous verification of Gear 2, clutch sub-assembly, and plunger heights.

04/

Cell 4 - Threading: Dose sleeve, spring, and button assembly. Force applied only at thread engagement position. Vision verifies dose button color (multi-variant).

05/

Cell 5 - Testing: KISTLER torque & injection force test (330 mm/s, 10.0 N ± 1.0 N). Force-displacement curve stored per unit. Vision confirms "0" position alignment before discharge.

GMP Material Selection

Product Contact	AISI 304 (0Cr19Ni9) austenitic stainless steel
High-Wear Parts	AISI 440 (7Cr17) hardened stainless steel
Polymers	Medical-grade PEEK + Acetal Copolymer (POM)
Mold Tooling	P20 / H13 / S136 tool steel \| CNC ±0.005 mm \| Ra ≤ 0.4 μm
Seals	PTFE / EPDM (FDA-compliant)
Lubrication	100% food-grade, isolated from product contact areas

Project Delivery: 8–12 Months

Concept & Feasibility	2–4 weeks
Design & Engineering	8–10 weeks (URS, FDS/HDS/SDS, 3D layout, mold design)
Mold & Tooling	6–8 weeks (CMM 100% inspection)
Manufacturing	12–16 weeks
FAT	2–3 weeks (IT / OT / Run testing with production-grade samples)
SAT & Qualification	2–4 weeks (IQ/OQ support, ≥72 hours training)
Warranty	1 year standard (extendable to 3) \| ≤12 h on-site (China) / 72 h (international)
Remote Support	24/7 VPN diagnostics \| Critical spares within 48 hours globally

Premium Component Ecosystem

Siemens	Rexroth	Keyence	KISTLER	SKF / FAG
PLC & HMI	Servo Drives	Vision & LVDT	Force / Torque	Bearings

The DROFEN automatic injection pen pre-assembly machine is engineered for high-speed assembly of insulin pen and GLP-1 pen core mechanisms at 160 parts per minute. This 5-cell modular platform integrates 26 servo axes, KISTLER force monitoring, and Keyence vision inspection to assemble 13 micro-components into a complete dosing mechanism with ≥98% yield and Cpk ≥1.33. The system is designed for pharmaceutical manufacturers and CDMOs requiring 21 CFR Part 11 compliant data integrity, recipe-driven changeover without mechanical tooling changes, and full GAMP 5 validation support including FAT/SAT and IQ/OQ documentation.

DROFEN delivers turnkey injection pen assembly lines from concept through qualification, with open-source PLC/HMI code and ≥20-year equipment lifespan.