ISO Class 8 Cleanroom Thermoforming | Custom Medical Packaging Manufacturer


Dordan Manufacturing is a fourth-generation, family-owned custom thermoformer specializing in medical packaging, blisters, clamshells, insert trays, and dunnage trays. Since 1962, we’ve delivered high-quality custom thermoformed packaging with short lead times, competitive pricing, and full-service support—from design through cleanroom manufacturing.

Dordan's cleanroom

Our in-house, ISO Class 8 certified cleanroom is purpose-built for the production of thermoformed medical packaging that meets the most stringent industry standards for sterility, consistency, and regulatory compliance.

Cleanroom Medical Thermoforming Capabilities


Located within our 50,000 sq. ft. facility in Woodstock, IL, Dordan’s fully enclosed, hardwall ISO Class 8 cleanroom is engineered to mitigate particulate and bio-burden contamination during the thermoforming process. The cleanroom is outfitted with Keifel thermoforming machines featuring advanced forming, cutting, stripping, and stacking stations—delivering precision-formed, high-quality medical packaging with every cycle.

Key Capabilities:

  • In-house cleanroom tooling design and assembly

  • Custom-built strippers and stackers for robotic automation

  • Heated cutting dies with tag-reduction placement for improved flange quality 

ISO-Certified Medical Packaging Manufacturer


Dordan is certified to:

  • ISO 9001:2015 – Quality Management Systems

  • ISO 13485:2016 – Medical Device Packaging Compliance

Our certified systems govern all cleanroom operating procedures, documentation, validation protocols, and traceability. As an end-to-end medical packaging supplier, we manage everything from thermoform design to tooling, cleanroom production, and quality control—all under one roof.

DOWNLOAD CLEANROOM/QC FACT SHEET

Cleanroom Manufacturing Quality Control


Dordan’s cleanroom manufacturing protocols are designed around continuous improvement, precision, and process control.

Our Process Includes:

  • Gowning procedures with complete gear changes for every entry

  • Positive air pressure differential between cleanroom and gowning/material staging rooms

  • FDA-approved cleaning protocols for all materials and tooling before entry

  • Particulate count testing per schedule, with environmental monitoring audits

  • Terminal cleaning and sterilization of cleanroom spaces

  • Automated optical inspection for rapid CPK capability analysis

  • Process validations, including First Article Validations and Full Process Validations 

Upon inspection approval, our engineering team generates a final production drawing that includes package specifications, tolerances, and part geometry for real-time monitoring and documentation.

DOWNLOAD DORDAN MEDICAL PROFILE

danny julian cleanroom mdm compressed

Why Choose Dordan for Medical Cleanroom Thermoforming?