Project Overview
A medical device company required sterilizable housings for their products. The project demanded USP Class VI certification, autoclave resistance, and biocompatibility.
Challenge
- USP Class VI: Biocompatibility certification
- Sterilization: 500+ autoclave cycles at 134°C
- Dimensional Stability: No warpage after sterilization
- Documentation: Complete biocompatibility records
- Volume: 100K+ units annual production
Solution
Medical-Grade Systems
- USP Class VI certified PP resin
- Cleanroom molding environment
- Validated sterilization protocols
- Comprehensive documentation
Testing & Validation
- USP Class VI biocompatibility testing
- Autoclave cycle testing (500+ cycles)
- Dimensional stability verification
- Mechanical property testing pre/post sterilization
Results
| Metric | Target | Achieved |
|---|---|---|
| Certification | USP Class VI | Achieved |
| Sterilization Cycles | 300 | 500+ |
| Dimensional Stability | ±0.5mm | ±0.2mm |
| Annual Volume | 50K units | 100K+ units |
| Quality Escapes | 0 | 0 |
Customer Testimonial
“CoreLMould’s medical housings are exceptional. USP Class VI certified, 500+ autoclave cycles validated, and perfect quality. Trusted medical manufacturing partner.”
- Regulatory Affairs Director, Medical Device Company