Custom Medical Grade PETG Injection Molded Box for Trocar
Custom Medical Grade PETG Injection Molded Box for Laparoscopic Trocar
This custom medical grade PETG injection molded box is designed specifically for laparoscopic trocars, endoscopic instruments and other Class II/III surgical devices that require rigid, durable sterile barrier protection. Unlike thermoformed blister trays, this injection molded box features thicker, more consistent wall thickness, stronger structural rigidity and precision-machined retention features that hold your trocar firmly in place during shipping, sterilization, storage and point-of-use handling.
Manufactured from medical grade PETG Eastar 6763 in our Class 10000 (ISO 7) certified cleanroom, each box is engineered with a uniform sealing flange compatible with heat sealing to Tyvek 1073B/1059B/2FS lids, PET lids or aluminum foil lids to form a complete sterile barrier system (SBS) per ISO 11607 standards. All materials are validated for EO, gamma and e-beam sterilization with no discoloration, brittleness or dimensional change, and we provide full documentation for FDA 510(k) and EU MDR regulatory submissions.
Key Design Features & Benefits
Product Specifications
| Parameter | Details |
|---|---|
| Manufacturing Process | Precision injection molding (medical grade cleanroom molding), not thermoforming |
| Material | Medical grade PETG (Eastar 6763), gamma-stabilized PETG available for high-dose gamma applications |
| Wall Thickness | 1.0mm – 3.0mm, uniform consistent thickness throughout the box (superior to thermoformed trays) |
| Box Size (This Model) | 180mm x 80mm x 50mm (custom sizes available up to 300mm x 200mm x 100mm) |
| Cavity Design | Custom precision-machined cavity for trocar shaft, handle and accessories, with retention snaps and positioning posts |
| Sealing Flange | 8mm+ uniform flat flange for consistent, reliable heat sealing with all common medical lid materials |
| Compatible Lid Materials | Tyvek 1073B/1059B/2FS, PET, APET, aluminum foil, multi-layer co-extruded lids per ISO 11607 |
| Sterilization Compatibility | Ethylene Oxide (EO), Gamma irradiation, E-beam irradiation, low-temperature plasma |
| Production Environment | Class 10000 (ISO 7) certified cleanroom for injection molding, assembly and packaging, 24/7 monitoring |
| Compliance Standards | ISO 10993 biocompatibility, ASTM F1980 aging, ISO 11607, FDA 21 CFR Part 820, EU MDR, PPWR compliant |
| Minimum Order Quantity | 10,000 pieces for injection molded production (tooling cost is one-time), 50-200 piece prototype runs available |
| Lead Time | Mold manufacturing: 3-4 weeks. Prototypes: 7-10 working days after mold completion. Production: 20-25 working days. |
Typical Applications
Injection Molded vs Thermoformed Packaging
For heavy, sharp or high-value surgical instruments like trocars, injection molded boxes offer significant advantages over standard thermoformed blister trays:
| Feature | Injection Molded Box (This Product) | Standard Thermoformed Tray |
|---|---|---|
| Wall Thickness Consistency | Uniform 1.0-3.0mm throughout, no thin corners | Variable thickness, corners and deep draws can be 50% thinner |
| Structural Rigidity | High rigidity, resists cracking and deformation under load | More flexible, can crack or deform with heavy/sharp instruments |
| Feature Precision | Tight tolerance snaps, undercuts and complex retention features | Limited to draft-angle friendly features, no undercuts |
| Impact Resistance | Superior impact resistance, ideal for shipping heavy instruments | Lower impact resistance, more prone to shipping damage |
| Tooling Cost | Higher upfront injection mold cost | Lower upfront thermoform tooling cost |
| Best For | High-volume, high-value, heavy or sharp surgical instruments | Low-volume, lightweight, simple-shaped devices |
How Customization Works
Quality & Compliance
All our medical grade injection molded packaging meets the strict requirements of biocompatibility, aging, sterilization, bioburden and particle control for medical device packaging:
- Biocompatibility: ISO 10993 certified materials, non-cytotoxic, non-irritating and non-sensitizing
- Aging Testing: ASTM F1980 accelerated aging testing to validate shelf life and packaging integrity (up to 5 years for PETG)
- Sterilization Validation: Materials validated for EO, gamma and e-beam sterilization with no degradation
- Mold Validation: Full IQ/OQ/PQ mold validation reports, first article inspection (FAI) and dimensional inspection reports
- Bioburden Control: Cleanroom production with strict bioburden monitoring and control per ISO 11737
- Particle Control: Low particulate generation materials and cleanroom processing to meet medical device particle requirements
- Traceability: Full material batch traceability, mold cavity traceability and lot number tracking for every production run
- Quality System: ISO 13485:2016 certified quality management system, audited annually
Complete Your Sterile Barrier System
We manufacture all components of your sterile barrier system in-house, so you can get everything from one supplier with consistent quality and simplified documentation:
Frequently Asked Questions
Need a Custom Quote for Your Injection Molded Medical Packaging?
Send us your device dimensions, drawings or samples. Our engineering team will review your requirements and provide a free quotation with DFM feedback, mold flow analysis, material recommendations and project timeline within 3 business days. No obligation, no pressure.
