Thermoformed medical device packaging

Custom thermoformed packaging for medical device companies and their supply chain partners, with in-house design, tooling, thermoforming, and ISO Class 8 cleanroom manufacturing

Request a Quote

Cleanroom thermoforming of medical packaging

thermoformed medical packaging

Custom thermoformed packaging for medical devices

Medical device manufacturers use custom thermoformed packaging to protect, organize, and present medical devices throughout manufacturing, handling, sterilization, distribution, and clinical use. Dordan manufactures a range of packaging solutions, including medical device trays, surgical and procedural kits, medical handling trays, medical blisters, and medical clamshells.

Medical packaging requirements vary according to device dimensions, intended use, and whether a sterile barrier system is needed. Package design and material selection must account for device protection, compatibility with sterilization methods such as ethylene oxide (EtO), gamma irradiation, and electron beam (e-beam), manufacturability, and aseptic presentation where applicable.

Quality requirements, including dimensional inspection, traceability, and process validation, are established based on the application and customer specifications.

Dordan supports these requirements through integrated package design, in-house tooling, ISO Class 8 cleanroom thermoforming, and ISO 13485:2016-certified quality management systems.

Medical Device Trays

Custom thermoformed trays designed to protect, retain, and present medical devices while supporting sterilization, distribution, and point-of-use access.

Surgical & Procedural Kits

Thermoformed trays and lids that organize medical devices and components for assembly, sterilization, and efficient clinical use.

Medical Handling Trays

Thermoformed trays for cleanroom handling, assembly, inspection, and internal product movement.

Medical Blisters

Custom thermoformed blisters for smaller, lightweight medical devices and components, designed for protection, visibility, and efficient presentation.

our process

Packaging development process

Dordan's medical packaging development process begins with understanding the application. Customers work with an experienced Dordan sales engineer to define device, packaging, sterilization, manufacturing, and performance requirements.

Before formal design begins, each project undergoes an engineering review followed by a cross-functional review with Quality and Production to identify potential manufacturing risks, design considerations, and quality requirements.

Dordan then prepares an engineering report outlining the proposed design approach, outstanding questions, and information needed to proceed. Following customer review, engineering drawings are developed for approval before prototyping, production tooling, and thermoforming.

Design & Engineering

Custom medical packaging is designed in Siemens NX around device dimensions, package performance, manufacturing requirements, and the thermoforming process. Engineering drawings and project-specific engineering reports document critical dimensions, design requirements, manufacturability, and forming considerations before tooling development.

Tooling & Prototyping

Prototype and production tooling is CNC-machined in-house from aluminum using NX CAM. Prototype tooling supports sample development and customer review before production tooling is finalized, helping verify package dimensions, fit, function, and manufacturability early in development.

Cleanroom Manufacturing

Medical packaging is thermoformed in Dordan’s ISO Class 8 cleanroom on dedicated equipment for medical packaging production. In-house cleanroom manufacturing supports controlled, repeatable production using approved tooling and documented manufacturing processes.

Quality & Validation

Medical packaging production is supported by Dordan’s ISO 13485:2016 and ISO 9001:2015-certified quality management systems. Quality controls include first article inspection, first article validation, with process validation and Cpk capability studies available upon request.

Cleanroom & quality

ISO Class 8 cleanroom manufacturing & quality control

Dordan manufactures custom medical device packaging in a 3,200-square-foot, hard-wall ISO Class 8 cleanroom. Temperature, humidity, and airborne particulate levels are controlled and monitored to maintain specified manufacturing conditions.

Documented standard operating procedures support contamination control, including measures to manage and mitigate risks associated with bioburden and microbial contamination throughout cleanroom production.

Manufacturing operates under Dordan's ISO 13485:2016-certified quality management system. First article inspection (FAI) and first article validation (FAV) verify critical dimensions and packaging requirements, with process capability (Cpk) studies incorporated as applicable.

For medical packaging programs requiring full process validation, Dordan supports installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) based on customer and project requirements.