Thermoformed Medical Trays & Packaging | ISO 13485:2016 Certified 

Dordan Manufacturing is a custom designer and manufacturer of thermoformed medical packaging like medical device trays, blisters, clamshells, procedural kits, and handling trays. This packaging is engineered and manufactured for safety, compliance, and performance. Certified to ISO 13485:2016 and ISO 9001:2015, Dordan is a full service medical packaging supplier with in-house design, tooling, plastics thermoforming, and ISO Class 8 cleanroom manufacturing.

Medical Packaging Applications 

• Medical Device Trays: Designed to protect, keep clean, and maintain the safety and efficacy of the medical device, medical trays are often sealed via a raised seal flange to lidding prior to sterilization. Medical device trays are designed to meet the needs of the end user while integrating good thermoforming principles, resulting in the production of high quality medical packaging. 

• Surgical and Procedural Kits: Trays with inserts and/or lids organize and orient medical components and devices for procedural workflow gains, using snap retaining features to secure products during shipping while allowing end users to easily remove. Usually sealed to lidding, procedural kits can contain many different SKUs in an organized and compact format. 

• Medical Blister Packaging: Medical blisters differ from medical trays in that they do not have a raised seal flange-- the lid stock is sealed directly to the flange at sheet level. Medical blisters and trays fulfill many of the same requirements, though blisters are more appropriate for smaller, lighter, and thinner profile items. Medical blisters tend to be used for less-critical medical products, when compared to medical device trays.   

• Medical Clamshells: A more durable solution where the medical product is completely contained in the package and closed with a hinged-- no lid stock necessary. This is helpful for devices and components that do not lend themselves to medical trays and blisters. However, a pouch is required if this is to be a sterile package, as a clamshell is not airtight. 

• Component Handling & Assembly Trays: Designed for shipping, manual and automated parts handling, and WIP optimization, these trays protect medical components and offer supply chain gains. Design features of medical handling trays include: stack and rotate, which provides clearance between the products and stacked trays; hand access; formed locators that position the tray in the automation cell, etc. 

Fully-Integrated Medical Thermoforming Capabilities

• Package Design – We utilize Siemens NX for the development of medical trays and packaging. All medical packaging design is performed under Dordan's ISO 9001:2015 and ISO 13485:2016 certifications that require collaboration, documentation, transparency, and compliance. Dordan uses this as the foundation of its approach to package design, while also integrating design for manufacturing principles, allowing for the production of high quality medical tray packaging. 

• In-House Tooling – NX CAD/CAM for CNC programming and machining of prototype and production tooling. All tooling is programmed by the same team of packaging engineers that developed the design, reducing translation errors. Dordan's tool shop houses 3 CNC machines that run 24/7, seven days a week, and are capable of producing molds up to 30" x 36" x 6". 

• Thermoforming – 14 thin-gauge in-line plastic thermoforming machines are capable of converting millions of pounds of plastic a year. 

• ISO Class 8 Cleanroom Manufacturing – Dordan's cleanroom offers a controlled environment for manufacturing medical packaging intended for sterile or non sterile applications. A fully enclosed and complete hardwall constructed space, the cleanroom is equipped with two machines and is monitored per the ISO Class 8 standards and ISO 13485:2016 requirements for medical packaging. 

• ISO 9001:2015 & ISO 13485:2016 Certified – Dordan's quality management system is the foundation of our design, tooling, and manufacturing operations. It offers quantifiable data on where we excel and where we can improve. Our commitment to our quality management system allows us to offer direction to our clients as they navigate the regulatory landscape.