Packaging of Radiopaque Marker Bands

Cleanroom Handling, Glass Vial Storage, and Tray-Based Protection

Radiopaque marker bands are precision-engineered components used in minimally invasive medical devices. Their small size and tight dimensional tolerances require carefully controlled packaging to ensure cleanliness, integrity, and protection throughout handling, storage, and global transportation.
This article outlines the packaging methods we use to preserve product quality and to support efficient downstream assembly for our customers.

1. Controlled Packaging Environment

All marker bands are packaged inside an ISO Class 7 cleanroom.
Before entering the packaging area, each batch undergoes:

Ultrasonic cleaning
DI water or IPA rinsing
Particle and debris removal
Drying in controlled conditions
Visual inspection under magnification

Packaging inside a cleanroom minimizes contamination risks and ensures that each marker band remains free of particles, oil residue, or handling marks—an essential requirement for medical device manufacturing.

2. Primary Packaging – Glass Vial Packaging

Our main packaging method is glass micro vials, which provide safe, reliable storage for radiopaque marker bands of all sizes and materials.

Why Glass Vials?

Excellent protection against abrasion and mechanical impact
Clear visibility for quick quantity verification and inspection
Anti-static and non-reactive materials suitable for Pt-Ir, Ta, W, Au, and Nitinol marker bands
Flexible capacity for both small custom orders and high-volume production
Cleanroom labeling for full traceability

Each glass vial is sealed and labeled with:

Part Number
Material
Quantity
Lot / Batch Number
Packaging Date
Inspection Status

This method ensures secure handling and straightforward integration into customer inventory systems.

3. Tray-Based Packaging – Individually Placed Components

For certain products, particularly ultra-small, thin-wall, or high-precision marker bands, we use tray-based packaging with individual slots.

Advantages of Tray Packaging

Prevents contact between parts, eliminating risk of scratching or deformation
Maintains part orientation for automated or manual assembly
Keeps materials organized for easy visual inspection
Reduces human handling to maintain cleanliness
Supports high-precision manufacturing workflows

Trays are typically made of durable, cleanroom-compatible materials such as polycarbonate (PC) or PEEK, offering both stability and protection.

Tray packaging is typically used when customers require:

Extremely delicate or specialty marker bands
Controlled placement for automated equipment
Clear separation of lots or material types

4. Secondary Packaging for Transportation

Once primary packaging is complete, all vials and trays are secured in robust secondary packaging designed for international shipment.

Secondary packaging may include:

Protective foam inserts
Moisture-control materials such as desiccants
Anti-static bags when required
Multi-layer shipping boxes for shock absorption

Each outer package includes full labeling for traceability:

Part Number
Material and Quantity
Lot Number
Packaging Date
Customer Order Information

This ensures the products remain protected from vibration, moisture, and accidental damage during handling and transit.

5. Traceability and Documentation

To support medical device regulatory requirements, every shipment includes documentation such as:

Material Certifications
Dimensional Inspection Reports
Cleanliness or Visual Inspection Records
Packaging Logs
Lot and Batch Traceability Documentation

This system ensures that every marker band can be traced from raw material to final packaging.

Conclusion

Our packaging process is designed to protect marker bands at every stage of their journey—from cleanroom preparation to final delivery.
By combining:

Cleanroom packaging,
Glass vial storage, and
Precision tray-based packaging,

Edgetech Industries (ETI) ensure that each radiopaque marker band arrives in optimal condition, ready for integration into advanced medical devices. Our packaging methods preserve surface integrity, maintain cleanliness, and support complete traceability, delivering reliability and consistency to our global customers.