Custom Medical Grade PETG Blister Tray for Interventional Catheters
This custom medical grade PETG blister tray is designed specifically for interventional catheters, guidewires and other Class II/III medical devices that require secure positioning and sterile barrier protection. Manufactured from medical grade PETG Eastar 6763 or SK S2008 in our Class 10000 (ISO 7) certified cleanroom, each tray features precision-machined retention cavities that hold your device firmly in place during shipping, sterilization and storage, preventing movement and damage.
The tray is engineered with an 8mm+ 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
Medical Grade PETG Only
Only Eastar 6763 / SK S2008 medical grade PETG, with full ISO 10993 biocompatibility reports and batch traceability.
Precision Retention Cavities
Custom-machined cavities and snap features hold your catheter or instrument firmly, preventing movement and damage during transit.
ISO 7 Cleanroom Production
All forming and assembly in Class 10000 (ISO 7) certified cleanroom with 24/7 environmental and bioburden monitoring.
Multi-Sterilization Compatible
Validated for EO, gamma and e-beam sterilization with no discoloration, brittleness or dimensional change.
Sterile Barrier System Ready
8mm+ uniform sealing flange, heat sealable with Tyvek, PET or foil lids per ISO 11607 sterile barrier standards.
Full Validation Support
Complete documentation for FDA & EU MDR: biocompatibility, FAI, aging, sterilization validation, cleanroom records.
Product Specifications
Parameter
Details
Material
Medical grade PETG (Eastar 6763, SK S2008), APET available on request
Material Thickness
0.4mm – 1.2mm, custom optimized for minimum weight while meeting strength requirements
Tray Size (This Model)
120mm x 120mm (custom sizes available up to 500mm x 350mm)
Cavity Design
Single cavity with precision retention snap features for catheter handle, custom multi-cavity layouts available
Sealing Flange
8mm+ uniform flat flange for consistent heat sealing with lid materials
Class 10000 (ISO 7) certified cleanroom, 24/7 environmental and bioburden monitoring
Compliance Standards
ISO 10993 biocompatibility, ASTM F1980 aging, ISO 11607, FDA 21 CFR Part 820, EU MDR, PPWR compliant
Minimum Order Quantity
5,000 pieces for production, 50-200 piece prototype runs available for validation
Lead Time
Prototypes: 5-7 working days. Production: 15-20 working days after sample approval.
Typical Applications
Interventional Catheters & Guidewires
Electrophysiology Catheters
Cardiac Rhythm Device Accessories
Surgical Instruments & Procedure Kits
Orthopedic & Spinal Implants
Dental & Ophthalmic Devices
Aesthetic & Cosmetic Medical Devices
Staplers & Energy Devices
How Customization Works
1
Design Review
Send us your device dimensions, drawings or samples. We provide free DFM feedback, material recommendation and quote within 2 business days.
2
Prototype Sampling
We cut a prototype die and produce 50-200 sample trays in 5-7 working days. You test fit with your actual devices and provide feedback for adjustments.
3
Validation & Tooling
Once design is finalized, we produce production tooling and run first article inspection (FAI). We support all IQ/OQ/PQ validation activities for your regulatory submission.
4
Mass Production
Production runs in ISO 7 cleanroom with full batch traceability. Standard lead time 15-20 working days. We can also heat seal lids and pack into cartons if required.
Quality & Compliance
All our medical grade blister materials meet 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
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 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:
Tyvek Lids
Custom die-cut Tyvek 1073B/1059B/2FS lids, heat sealable to our blister trays, with optional printing and UDI marking.
Q: What sterilization methods are these blister trays compatible with?
A: Our PETG blister trays are fully compatible with Ethylene Oxide (EO), gamma irradiation and e-beam irradiation sterilization. We can also provide material sterilization validation data upon request. For high-dose gamma applications above 50kGy, we recommend gamma-stabilized PP material.
Q: Can you customize the cavity layout for my specific device?
A: Yes. Every tray we produce is fully custom designed around your exact device dimensions. We can create single or multi-cavity layouts, add retention snap features, positioning posts, coil channels for catheters, and any other features required to hold your device securely. Send us your device drawings or samples for a free design review.
Q: Can you provide material compliance certificates for regulatory submissions?
A: Yes. We provide full material certificates including ISO 10993 biocompatibility reports, FDA food contact notification, RoHS/REACH compliance and material batch traceability documents with every order. We can also provide all documentation in the format required for FDA 510(k) and EU MDR technical files.
Q: Can you heat seal lids to the trays, or do you only supply trays?
A: We can provide both. You can order trays only, or we can heat seal matching Tyvek, paper or foil lids to the trays in our cleanroom and deliver complete pre-sterilized sterile barrier systems. We can also include lot number, expiration date and UDI marking on the lids if required.
Need a Custom Quote for Your Medical Blister Packaging?
Send us your device dimensions, drawings or samples. Our engineering team will review your requirements and provide a free quotation with material recommendations, DFM feedback and prototype timeline within 24 hours. No obligation, no pressure.
