Custom Multi-Cavity PETG Medical Blister Tray for Syringe Kits

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Custom Multi-Cavity PETG Medical Blister Tray for Syringe Kits & Procedure Packs

This custom multi-cavity medical grade PETG blister tray is designed specifically for syringe kits, procedure packs and multi-component surgical instrument sets that require organized, secure positioning of multiple devices in a single sterile package. Manufactured from medical grade PETG Eastar 6763 or SK S2008 in our Class 10000 (ISO 7) certified cleanroom, each tray features multiple precision-machined cavities of varying sizes and shapes, engineered to hold syringes, needles, forceps, scissors, gauze and other procedure components firmly in place during shipping, sterilization and storage.

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. We can also include positioning posts, retention snaps, coil channels and any other custom features required for your specific kit configuration.

Key Design Features & Benefits

Multi-Cavity Custom Layout

Fully custom cavity layout with varying sizes and shapes to organize all components of your procedure kit in one tray.

Medical Grade PETG Only

Only Eastar 6763 / SK S2008 medical grade PETG, with full ISO 10993 biocompatibility reports and batch traceability.

Precision Retention Features

Custom positioning posts, retention snaps and coil channels hold each component 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.

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 – 1.5mm, custom optimized for minimum weight while meeting strength requirements
Tray Size (This Model) 220mm x 150mm (custom sizes available up to 500mm x 350mm)
Cavity Design Multi-cavity layout with varying sizes and shapes for syringes, needles, instruments and accessories, custom retention snaps and positioning posts
Cavity Count 2 – 50+ cavities per tray, fully custom layout based on your kit configuration
Sealing Flange 8mm+ uniform flat flange for consistent heat sealing with lid materials
Compatible Lid Materials Tyvek 1073B/1059B/2FS, PET, APET, aluminum foil, multi-layer co-extruded lids
Sterilization Compatibility Ethylene Oxide (EO), Gamma irradiation, E-beam irradiation, low-temperature plasma
Production Environment 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

Syringe & Needle Kits

Surgical Procedure Packs

IV Start Kits & Catheter Kits

Dressing & Wound Care Kits

Orthopedic Instrument Sets

Dental Procedure Kits

Ophthalmic Surgery Kits

Aesthetic & Cosmetic Procedure Kits

How Customization Works

1

Kit Design Review

Send us your kit component list, dimensions, drawings or samples. We provide free DFM feedback, cavity layout optimization, 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 all your actual kit components and provide feedback for layout 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.

View Tyvek Lids →

Medical Mounting Cards

Custom HDPE/PP mounting cards for catheters and guidewires, used together with our blister trays for multi-component kits.

View Mounting Cards →

Sterilization Pouches & Bags

Tyvek pouches, paper-plastic pouches, head bags and aluminum foil bags for secondary packaging or standalone sterile barrier systems.

View Sterilization Pouches →

Frequently Asked Questions

Q: Can you design a custom cavity layout for my specific procedure kit?

A: Yes. Every tray we produce is fully custom designed around your exact kit configuration. Send us your component list with dimensions, drawings or samples, and our engineering team will design an optimized cavity layout that organizes all components securely, minimizes tray size and weight, and allows for easy aseptic presentation at point of use. We provide free DFM feedback and 3D layout drawings before prototype production.

Q: What sterilization methods are these multi-cavity 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. For steam sterilization, we recommend PP or PC materials instead of PETG.

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, including first article inspection reports, cleanroom monitoring records and sterilization validation support.

Q: Can you heat seal lids to the trays and deliver complete sterile barrier systems?

A: Yes. 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, and pack the finished trays into cartons ready for sterilization.

Need a Custom Quote for Your Multi-Cavity Medical Blister Tray?

Send us your kit component list, dimensions, drawings or samples. Our engineering team will review your requirements and provide a free quotation with cavity layout optimization, material recommendations, DFM feedback and prototype timeline within 24 hours. No obligation, no pressure.

Request Free Quote Now →

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