Dordan Manufacturing is an ISO 13485:2016 and ISO 9001:2015 certified manufacturer of custom medical blister packaging for pharmaceutical and healthcare applications. We specialize in thermoformed medical blisters that provide sterile barrier protection for product safety, integrity, and ease of use. With 63 years of experience, Dordan offers in-house design, tooling, thermoforming, and cleanroom manufacturing, delivering high-precision blister packaging trusted by medical device OEM's and their supply chain partners.
Medical blisters are low-profile, thermoformed plastic cavities sealed with lidstock (e.g., foil, Tyvek®) to create unit-dose packaging for pharmaceuticals and medical devices. These blisters:
Create a sterile barrier system for product safety and efficacy
Offer tamper evidence and extended shelf life
Enable contamination prevention
Enhance product visibility, organization, and convenience
Tight Tolerances for Repeatability: Standard and customer-dictated critical dimensions and tolerances are continuously measured, monitored, and recorded during production to ensure consistent quality.
Clean Cut Edges with Heated Steel Dies: Heated stainless-steel cutting dies, paired with automated stripping and stacking modules, eliminate sharp edges and streamline downstream handling.
Optimized Tag Placement: Strategic tag design minimizes edge roughness and improves user safety during product opening.
Efficient, Low-Profile Designs: Locator features in the tooling ensure accurate die alignment for high-speed, high-volume blister production.
Dordan is a fully integrated manufacturer of thermoformed pharmaceutical blister packaging, offering:
Custom Blister Design: Dordan uses Siemens NX for the development of its medical plastic blister designs. We employ a risk-based approach to engineering with design for manufacturing principle integration. This results in the production of high performing medical blister packaging.
In-House CNC Tooling: NX CAD/CAM for prototypes and production tooling. All tooling is CNC machined from a single block of aluminum. The same team of engineers who developed the designs also program the tool paths, reducing translation errors for more intelligent quality control. Once the prototypes are approved, the geometry is replicated over the face of the production tooling via step and repeat, eliminating any inconsistencies between cavities.
Thermoforming in standard facility for less-critical medical blister packaging
ISO Class 8 Cleanroom thermoforming for pharmaceutical blister packaging
ISO 9001:2015 and ISO 13485:2016 certification requires that our standards for on time delivery of defect free products be met. Dordan's quality management system is the backbone of its design, tooling, and manufacturing operations, which ensures full transparency, traceability, and documentation.
Dordan's ISO Class 8 cleanroom is purpose built for the production of medical blister packaging. This controlled environment monitors particulate and bio burden agents, ensuring blister quality and cleanliness. Our cleanroom features include:
Advanced Equipment: Our cleanroom houses Keifel Speedformers equipped with automated forming, cutting, stripping, and stacking capabilities, ensuring precision and efficiency.
Environmental Controls: The facility maintains strict particulate and bioburden control, with regular monitoring to comply with ISO Class 8 standards.
Sterilization Protocols: We employ terminal cleaning protocols and use FDA-certified cleaning agents to maintain cleanliness and compliance.
Material Handling: Dedicated gowning and material staging areas with controlled air pressure zones prevent cross-contamination during the manufacturing process.
ISO13485:2016 Certified Quality
Full-Service Manufacturing in USA
ISO Class 8 Cleanroom
63 Years of Thermoforming Experience
Family Owned Since 1962