ISO Class 8 Cleanroom Thermoforming

Dordan Manufacturing is a fourth-generation, family-owned custom thermoformer with 63 years of experience. We excel at developing medical packaging. Our ISO Class 8 cleanroom is designed specifically for medical packaging applications, ensuring device safety, efficacy, and compliance with industry standards. Dordan’s cleanroom thermoforming services are backed by in-house design and tooling—giving you a single-source solution for validated, medical-grade packaging.

Dordan's cleanroom

What Is Cleanroom Thermoforming?

Cleanroom thermoforming is a manufacturing process in which plastic packaging is formed, cut, and handled in a controlled environment with low levels of airborne particulates. This process is essential for packaging medical devices, diagnostics, and other contamination-sensitive products that require sterile or ultra-clean conditions.

At Dordan, cleanroom thermoforming takes place in our ISO Class 8 certified facility, designed to meet the cleanliness standards outlined in ISO 14644. With filtered air, controlled temperature and humidity, and strict gowning procedures, our cleanroom ensures packaging is formed and handled in a particulate-controlled space from start to finish.

Why Cleanroom Thermoforming Matters

Supports Sterile Barrier Systems: Packaging is manufactured in an environment that minimizes contamination risk prior to sterilization.
Reduces Particulate Exposure: Especially critical for open-cavity trays, implantable devices, and diagnostic components.
Complies with Regulatory Standards: Cleanroom production helps meet ISO 13485, ISO 11607, and FDA packaging guidelines.

Applications of Cleanroom Thermoforming

Cleanroom thermoforming is essential for packaging applications where product integrity, sterility, and particulate control are critical. Dordan’s ISO Class 8 cleanroom supports the production of thermoformed packaging used in highly regulated industries that demand cleanliness, precision, and compliance.

Common Applications Include:

Medical Device Packaging: Custom trays for implants, surgical instruments, wound care products, and single-use devices—designed for sterile barrier systems and validated to ISO 11607.
Procedural Kits: Trays, lids, and inserts that protect and orient multiple products and components in one kit for optimized surgical workflow.
Pharmaceutical & Biotech Packaging: Blisters, inserts, and handling trays used in drug development, clinical trials, and pharma device distribution.
Electronics & Sensor Components: Packaging for sensitive microelectronics, sensors, and optical components requiring low particulate exposure.

Cleanroom Tooling

Precision tooling is the foundation of consistent, high-quality cleanroom thermoformed packaging. Our tooling supports not only complex part geometries but also process stability, material integrity, and particulate control—critical for sterile and contamination-sensitive applications.

Tooling Features & Capabilities:

Syntactic Foam Plug Assists: Used to control material distribution and minimize web thinning in deep-draw applications, these assist tools reduce the likelihood of sharp edges, stress points, or inconsistent wall thickness—essential for sterile barrier systems.
Heated Cutting Dies: Heated dies allow for cleaner cuts and reduce sharp edges.
Automated Strippers and Stackers: Efficiently strip packaging from the plastic web and stack for inspection.
Tolerancing for Cleanroom Production: All tooling is built to support repeatability within a CPK of 1.33 or higher, ensuring process capability, sealing surface integrity, and consistent material distribution.

Quality Control in Our ISO Class 8 Cleanroom

Our ISO 13485:2016 and ISO 9001:2015 certified Quality Management System ensures that each medical packaging product meets stringent regulatory standards and customer specifications.

Pre-Production Quality Measures

Material Verification: Incoming materials undergo thorough inspections to confirm quality and traceability.
First Article Inspection and Validation: Initial samples are evaluated to validate that they meet all specifications and functional requirements.
Equipment Calibration: All thermoforming equipment is calibrated and verified for readiness before production commences.
Quality Control Drawings (QC DWGs): Detailed drawings highlighting critical-to-quality dimensions are prepared to guide the manufacturing process.

In-Process Quality Control

Statistical Process Control (SPC): We employ SPC techniques to monitor and control the thermoforming process, ensuring consistent product quality.
Process Capability Analysis (CPK): Our tooling is designed to achieve a CPK of 1.33 or higher, indicating a high level of process capability and product consistency .
Automated Optical Inspection: Real-time defect detection is conducted using advanced optical systems to identify and address issues promptly.
Documentation and Traceability: All inspections and measurements are meticulously documented, providing full traceability and supporting continuous improvement initiatives.

Post-Production Quality Assurance

Final Inspection: Finished products are inspected, counted, and packaged according to client specifications.
Statistical Reporting: Performance data is analyzed and reviewed by our engineering and quality teams to identify areas for improvement.
Environmental Monitoring: Regular monitoring of particulate levels and environmental conditions within the cleanroom ensures compliance with ISO Class 8 standards.

Cleanroom-Specific Protocols

Controlled Environment: Our 3,200 sq. ft. ISO Class 8 cleanroom features hardwall construction and cascading filtered airflow to minimize contamination.
Gowning Procedures: Strict gowning protocols are enforced to prevent particulate contamination.
Sanitization Practices: The cleanroom undergoes regular deep cleaning and sanitization, including terminal sterilization processes.
Environmental Risk Assessments: Quarterly assessments are conducted to identify and mitigate potential contamination risks.

What Sets Us Apart

63 Years of Thermoforming Experience

ISO 9001:2015 & 13485:2016 Certified

Fully Integrated US Supplier

Risk-Based Engineering

4th-Generation Family-Owned and Made in USA Since 1962

Interested in Cleanroom Packaging?

Medical packaging