Pen injector customization & CDMO
From requirements and design to validation and volume production for drug–device combination projects.
CUSTOMIZATION / CDMO
From product concept to delivery
Development is phased around drug properties, applications, users and market pathways, coordinating tooling, molding, assembly, testing and delivery.
- 01Requirements assessment
- 02Structural & industrial design
- 03Prototyping
- 04Verification & validation
- 05Tooling development & delivery
| Item | Value / description |
|---|---|
| Customization scope | Structure, appearance, colors, logos, dose units, scales, viewing windows and packaging |
| Supported products | Dual-chamber, PFS, automatic, disposable and reusable pens; cartridges, needles and cases |
| Development stages | Concept, prototypes, tooling, pilot production and volume production |
| Validation areas | Dose accuracy, injection resistance, leakage, drop, vibration and stability |
| Deliverables | Drawings, samples, test reports, validation plans and batch traceability records |
Packaging & assembly support
| Item | Value / description |
|---|---|
| Cartridge | 3.0 mL; other sizes subject to project assessment |
| Needle interface | Luer needle / project-specific interface; validate the specific combination |
| Validation items | Needle torque, leakage, dose accuracy and compatibility |
| Final assembly components | Cap / cartridge holder / cartridge / pen body assembly |
| Packaging formats | Nested trays, trays, bags and reusable transport boxes |
VERIFICATION & VALIDATION
Product validation & testing
The catalog lists testing and compatibility validation based on ISO 11608 and YY/T 1768.1-2021. Applicable standards, configurations and acceptance criteria are confirmed by project.
| Item | Value / description |
|---|---|
| Appearance & markings | Burr, crack and sink-mark inspection; cartridge holder scales and dose markings |
| Dose accuracy | Last-dose accuracy; accuracy after free fall, temperature/humidity exposure and vibration |
| Operational & mechanical performance | Activation force, sustained injection force, cap removal force, torque and dial stability |
| Environment & service life | Dry heat, refrigeration, humidity, vibration, drop, accelerated aging and lifecycle tests |
| Compatibility & protection | Needle compatibility, leakage, guard activation and locking |
Test equipment
- Coordinate measuring machine
- Torque tester
- Temperature and humidity cycling chamber
- Universal mechanical testing machine
- Electromagnetic three-axis shaker
Validation documentation
Project-based validation plans, test reports, compatibility and stability validation, batch traceability records and customer audit support.
QUALITY & MANUFACTURING
Quality management & manufacturing support
Quality system
The catalog lists ISO quality management certification and production processes managed under GMP requirements.
Registration & filing documents
The catalog lists domestic pen injector registration, manufacturing authorization and packaging-material filings for disposable and PFS pens. Confirm products, scope and documents for each project.
Clean manufacturing
ISO Class 8 (grade 100,000) GMP cleanrooms, with grade 100 and 1,000 areas.
In-process quality control
Raw material, work-in-progress and finished-product inspection covering dimensions, mechanics, environment and vibration.
Production & traceability
- 01Incoming inspection
- 02Injection molding
- 03Assembly & inspection
- 04Labeling & packaging
- 05Batch traceability
| Item | Value / description |
|---|---|
| Automation equipment | 60 sets (catalog figure) |
| Precision injection molding machines | 82 machines (catalog figure) |
| Batch management | MES traceability |
| Project support | Prototype validation, pilot runs and scale-up |
| Quality records | Process parameters, in-line inspection, batch traceability and customer audit documents |
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