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Cleanroom thermoforming

ISO Class 8 cleanroom thermoforming for medical device trays, sterile barrier packaging, and contamination-sensitive manufacturing applications

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

Dordan manufactures custom thermoformed medical packaging in a 3,200-square-foot, hard-wall ISO Class 8 cleanroom. Our controlled manufacturing environment integrates dedicated thermoforming equipment, environmental monitoring, and documented procedures to support consistent production of contamination-sensitive medical packaging.

  • Dedicated Kiefel cleanroom thermoforming equipment
  • Controlled temperature, humidity, and airborne particulate levels
  • Cascading filtered airflow design
  • Separate gowning and material entry rooms
  • Personnel gowning protocols and documented operating procedures
  • Medical-grade PETG and application-specific materials
  • Dry fogging and contamination-control procedures
  • Pre, intermediate, and post-production cleaning protocols
  • Manufacturing of medical device trays, blisters, kits, and other sterile barrier packaging formats

Medical packaging applications

Cleanroom-manufactured packaging for medical device applications

Dordan manufactures thermoformed packaging for medical devices, surgical kits, and contamination-sensitive components, supporting product protection, organized handling, and medical manufacturing requirements.

Medical Device Tray

Medical Device Trays

Custom thermoformed trays designed for medical device protection, secure retention, aseptic presentation, and sterile barrier packaging applications.

medical blister packaging

Medical Blisters

Custom thermoformed blisters designed for individual medical device containment, compatibility with lidding materials, and sterile barrier packaging applications.

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.

Medical packaging quality control and process validation

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 9001:201 certified quality systems
  • Meets ISO 14644 Air Cleanliness Standards
  • First Article Inspection (FAI) and First Article Validation (FAV)
  • IQ, OQ, PQ, and PPAP validation support
  • Automated optical inspection and dimensional verification
  • Process capability studies (Cpk) and documented manufacturing controls
  • Packaging traceability and production documentation
Dordan's cleanroom for manufacturing medical packaging

Let's talk about your cleanroom packaging requirements

Tell us about your medical device and packaging requirements. Our team will review your inquiry and follow up within one business day, even if your specifications aren't finalized.

Contact Us Call (815) 334-0087