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Cleanroom manufacturing

ISO Class 8 cleanroom thermoforming developed for sterile barrier packaging and medical manufacturing requirements

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Medical packaging cleanroom manufacturing
Aric in cleanroom
Controlled manufacturing for medical packaging

Dordan manufactures thermoformed medical packaging within a 3,200 sq. ft. hardwall ISO Class 8 cleanroom designed for contamination-sensitive medical device packaging.

  • 3,200 sq. ft. hardwall ISO Class 8 cleanroom
  • Dedicated Kiefel cleanroom thermoforming equipment
  • Medical-grade material conversion
  • Controlled manufacturing and handling procedures
  • Cleanroom production for sterile barrier packaging
  • Medical device trays, blisters, clamshells, and kit packaging

Medical packaging applications

ISO Class 8 cleanroom thermoforming for medical packaging

Thermoformed medical packaging manufactured in an ISO Class 8 cleanroom to support validated production and contamination-sensitive applications.

Medical device tray packaging

Medical Device Trays & Blister Packaging

Thermoformed trays and blister packaging for sterile barrier systems, device protection, and validated manufacturing

Medical clamshell packaging

Medical Clamshells

Cleanroom-manufactured clamshells designed for product retention, visibility, and contamination-sensitive medical devices

Procedural kit packaging

Surgical & Procedural Kit Packaging

Packaging systems for organized presentation, component protection, and clinical workflows

Medical handling tray

Component Handling Trays

Thermoformed handling trays for component organization, transport, staging, and cleanroom manufacturing workflows

Quality systems built for regulated medical packaging

Dordan supports regulated medical packaging through documented quality systems, process validation, inspection, and production traceability to help maintain packaging consistency and regulatory compliance throughout manufacturing.

  • ISO 13485:2016 and ISO 9001:2015 certified quality systems
  • First Article Inspection (FAI) and First Article Validation (FAV)
  • IQ, OQ, PQ, and PPAP validation support
  • Automated optical inspection and dimensional verification
  • Process monitoring and documented manufacturing controls
  • Packaging traceability and production documentation
Dordan's cleanroom for manufacturing medical packaging

Medical packaging manufactured in a controlled environment

Dordan manufactures thermoformed medical packaging in an ISO Class 8 cleanroom backed by validated quality systems, documented processes, and in-house engineering