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Surgical and procedural kit packaging

Custom thermoformed procedural trays engineered for sterile field presentation, organized component access, and efficient clinical workflows

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Procedural kit packaging
Surgical kit packaging

Thermoformed packaging for surgical and procedural kits

Surgical and procedural kit packaging organizes multiple medical devices and components within a single thermoformed tray. Custom cavities and formed features position, retain, and separate individual components while providing access in the order they are needed during a procedure.

Dordan designs tray layouts around the specific contents of the kit, with consideration for component protection, sterile barrier requirements, aseptic presentation, and point-of-use access. The package can incorporate a raised seal flange to provide clearance between the packaged components and lidding material while creating a consistent sealing surface.

Procedural kit design & manufacturing

One parter from design through manufacturing

Dordan brings packaging design, tooling, and cleanroom manufacturing together under one roof, helping medical device manufacturers streamline development and coordinate production requirements. Our integrated approach supports consistency from initial prototyping through full-scale manufacturing.

 

surgical procedural kit engineering

Packaging Design & Engineering

Procedural kits are designed in Siemens NX with consideration for component organization, sterile packaging requirements, retention features, and manufacturability

CNC machine for producing kit tooling

In-House Tooling

Prototype and production tooling is CNC-machined in-house to maintain cavity accuracy, retention detail, sealing surfaces, and repeatable forming performance

cleanroom thermoforming of medical kit packaging

Cleanroom Thermoforming

Surgical and procedural kit packaging is manufactured in Dordan’s ISO Class 8 cleanroom for applications requiring controlled production conditions

surgical kit thermoforming quality control

Quality & Validation

Medical packaging programs are supported by Dordan’s ISO 13485:2016-certified quality management system, with inspection and validation requirements established for each project

cleanroom-thermoforming-medical-packaging-2

Cleanroom manufacturing, quality & validation

Dordan manufactures surgical and procedural kit packaging in its 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 operating procedures support contamination control and help manage bioburden risks throughout production.

Manufacturing operates under Dordan's ISO 13485:2016-certified quality management system. First Article Inspection (FAI) verifies critical tray dimensions and packaging requirements, while First Article Validation (FAV) evaluates manufacturing consistency and process capability through Cpk studies.

For surgical and procedural kits containing multiple components, dimensional accuracy, component retention, and seal-flange geometry are especially important. Dordan supports these requirements through project-specific quality plans, with additional process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), available based on customer requirements.

Let's scope your procedural kit packaging project

Share your device dimensions and protection requirements — even if specs aren't finalized — and a specialist will review your project and follow up same-day. No automated quotes, no pressure.

Request a Quote Call (815) 334-0087