Dordan Manufacturing designs and manufactures custom procedural and surgical kits in its ISO Class 8 certified cleanroom, supporting medical OEMs and contract manufacturers with reliable, high-performance packaging solutions.
Since 1962, our family-owned company has provided thermoformed medical trays and lids that streamline surgical workflows, reduce contamination risk, and meet the highest standards for cleanliness, safety, and usability.
Medical procedural kits are packaging systems that contain all instruments and components needed for a surgical or clinical procedure. Each kit is engineered for ease of use, sterility, and intuitive access, improving operational efficiency for healthcare professionals. Dordan’s thermoformed trays and kits are:
Designed for intuitive product placement and orientation
Manufactured with snap-fit, press-fit, or friction-fit cavities
Optimized for finger access to support fast, safe device removal
Cleanroom produced for sterility and precision
We offer flexible kit formats tailored to your product and sterilization needs:
Tray + Snap-On or Press-Fit Lid
Ideal for non-sterile medical kits
Simple fulfillment process with no secondary sealing required
Rigid lid protects contents during storage and transport
Tray + Lid Inside Tyvek® Pouch
Suitable for sterilized kits without heat sealing equipment
Offers clean barrier protection
No heat seal tooling investment required
Tray + Heat-Sealed Tyvek® Lidstock
Provides peel-open sterile packaging
Easy opening for healthcare professionals
Supports ETO, gamma, or steam sterilization
All kits can be designed with custom-fit features to secure products during handling, shipping, and use. Every design prioritizes clean removal, intuitive layout, and low particulate generation.
Dordan provides end-to-end kit manufacturing, including:
NX CAD design of thermoformed trays and lids
CNC tooling built in-house using NX CAM
Standard plastics thermoforming for less-critical medical kit packaging
By handling the full development process internally, Dordan eliminates the risk of translation errors between design and tooling. This ensures consistency, fast turnaround, and optimal quality from prototype to production.
Dordan’s custom surgical and procedural tray packaging solutions are trusted by a wide range of medical industry professionals and suppliers. Designed for sterile or non-sterile presentation, secure transport, and intuitive use, our thermoformed kits support critical functions across several markets:
Medical Device Manufacturers: We partner with OEMs producing surgical instruments, implants, and diagnostic tools that require sterile (or non sterile), organized presentation and protective packaging for hospital and clinical use.
Hospitals & Surgical Centers: Our custom kits help streamline operating room efficiency by organizing instruments and disposables in the exact sequence required for specific procedures—reducing prep time and risk of contamination.
Contract Manufacturers & Assemblers: We supply thermoformed procedural trays that integrate with cleanroom assembly and sealing operations. Designed for automation compatibility, our trays improve workflow and protect components during packaging.
Pharmaceutical & Biotech Companies: For diagnostic kits, sample collection trays, and pre-filled device packaging, our thermoformed kits offer protection, usability, and compliance with healthcare regulations and sterilization requirements.
Whether you're launching a new procedural system or scaling existing operations, Dordan provides flexible, high-quality packaging solutions engineered for safety, performance, and speed to market.
Packaging for surgical and procedural kits demands the highest levels of cleanliness, precision, and process control. That’s why Dordan manufactures these thermoformed components in a purpose-built, ISO Class 8 cleanroom designed for medical-grade performance.
Highlights of Our Cleanroom Environment:
Fully enclosed and complete hard wall environmentally controlled environment minimizes airborne particulates and bio burden agents.
Dedicated Equipment & Tooling: Keifel thermoformers outfitted for cleanroom use and engineered with syntactic foam plug assists and heated cutting dies for optimal material control.
Validated Workflows: Comprehensive gowning procedures, airlocks, and material segregation support GMP protocols and reduce contamination risk.
Routine Monitoring: Regular particulate count testing and documented sanitation cycles ensure continuous compliance with ISO 14644 cleanroom standards.
Whether you're sourcing rigid trays for device kits or multi-cavity packaging for procedure sets, our cleanroom infrastructure ensures a hygienic, controlled process from start to finish.
In surgical environments, quality isn’t just a priority—it’s a prerequisite. Dordan’s certified quality management system ensure that every packaging component we produce aligns with your validation, compliance, and performance expectations.
What Sets Our Quality System Apart:
Regulatory Alignment: ISO 13485:2016 and ISO 9001:2015 certifications underscore our commitment to medical manufacturing best practices.
Robust Inspection Protocols: Every production run undergoes incoming, in-process, and final inspections—documented and supported by CPK analysis and visual inspection standards.
Process Validation Expertise: From IQ, OQ, PQ to PPAPs, our team works alongside yours to establish repeatable, defensible processes tailored to your product's requirements.
Traceability & Documentation: Each lot is supported by comprehensive documentation, from material certs and tooling specs to inspection reports and packaging validations.
By pairing cleanroom manufacturing with a rigorous quality control framework, Dordan delivers thermoformed surgical packaging solutions that meet clinical demands—without compromise.
When sourcing packaging for surgical and procedural kits, precision, cleanliness, and reliability are non-negotiable. Here’s why medical device manufacturers trust Dordan:
We specialize in thermoformed trays engineered for surgical instruments and procedure packs—produced in an ISO Class 8 cleanroom and supported by ISO 13485:2016 certification.
From design and tooling to thermoforming and validation, all processes are performed in-house, reducing risk, shortening lead times, and ensuring complete control over quality.
Our team collaborates with yours to design custom packaging that fits your device, sterilization method, and handling requirements—no one-size-fits-all solutions here.
Robust quality controls—including full IQ/OQ/PQ validations, AQL-based sampling, and detailed documentation—ensure your packaging meets regulatory and clinical demands.
As a fourth-generation, family-owned business, we bring a level of service, responsiveness, and commitment that large corporations often can’t match.
Start Your Custom Surgical Kit Project
Looking for a trusted partner for custom procedural kits or thermoformed surgical trays? Contact Us or Request a Quote today to start developing your solution with Dordan.