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 oral drugs, topical medications, and unit-dose formulations—ensuring product safety, integrity, and ease of use.
With over 62 years of experience, Dordan offers in-house design, tooling, thermoforming, and cleanroom manufacturing, delivering high-precision blister packaging trusted by medical device OEM's, pharmaceutical companies, and their supply chain partners.
Medical blisters are low-profile, thermoformed plastic cavities sealed with lidstock (e.g., foil, Tyvek®, or paperboard) 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 controlled dosing and contamination prevention
Enhance product visibility, organization, and convenience
Engineered for precision, Dordan’s medical blister trays and packaging offer consistent performance from fulfillment to end use:
Tight Tolerances for Repeatability: Formed cavity-to-cavity and form-to-cut specifications 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 with Siemens NX Solid Modeling
In-House CNC Tooling for prototypes and production molds
Thermoforming in standard facility for less-critical medical packaging
ISO Class 8 Cleanroom thermoforming for critical medical devices
By keeping design, tooling, and manufacturing in-house, Dordan eliminates translation errors and ensures tight control over quality, timing, and cost.
Dordan’s thermoformed pharmaceutical blister packaging supports a variety of healthcare and life science markets that demand precision, cleanliness, and regulatory compliance. Our custom blisters are designed to maintain product integrity from fulfillment through end use, whether for clinical, retail, or diagnostic applications.
Pharmaceutical Manufacturers: We supply blister packaging for oral solid doses, topical treatments, and unit-dose medications—providing tamper resistance, dosage accuracy, and compliance with FDA labeling and packaging standards.
Diagnostic & Laboratory Testing Companies: Dordan’s blisters are used in diagnostic kit components, sample handling trays, and reagent packaging. Our ISO Class 8 cleanroom production ensures controlled environments for sensitive biological materials.
Medical Device & Drug Delivery OEMs: For combination products and prefilled delivery systems, our blisters offer secure housing and compatibility with barrier films and lidding, maintaining sterility and performance throughout the supply chain.
Clinical Trial & Specialty Pharma Suppliers: We support small-batch and specialty packaging programs with fast turnaround thermoformed blisters tailored to trial, promotional, and short-run commercial applications.
Dordan Manufacturing operates a state-of-the-art ISO Class 8 cleanroom, purpose-built for the production of medical blister packaging. This controlled environment ensures the highest levels of cleanliness and sterility, critical for pharmaceutical applications.
Key Cleanroom Features:
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 14644 standards.
Sterilization Protocols: We employ terminal cleaning protocols and use FDA-certified cleaning agents to maintain a contaminant-free environment.
Material Handling: Dedicated gowning and material staging areas with controlled air pressure zones prevent cross-contamination during the manufacturing process.
Our cleanroom capabilities enable us to produce pharmaceutical and medical blisters that meet stringent regulatory requirements, ensuring product safety and integrity from production to end-use.
Our Quality Management System is certified to both ISO 9001:2015 and ISO 13485:2016 standards, reflecting our commitment to excellence in pharmaceutical packaging.
Our Quality Assurance Process Includes:
Risk-Based Management: We conduct thorough risk assessments during the design and manufacturing phases to identify and mitigate potential issues, ensuring product reliability and compliance.
Validation: FAI, FAV, Full Process Capability Studies, PPAP, other
In-Process Monitoring: Utilizing real-time CPK (Process Capability Index) analysis, we monitor production processes to maintain consistent quality and adherence to specifications.
Comprehensive Inspections: Our quality control procedures encompass incoming material inspections, first article inspections, and equipment readiness checks to uphold the highest standards.
Documentation and Traceability: We maintain detailed records for every product batch, facilitating traceability and accountability throughout the production lifecycle.
When your pharmaceutical packaging demands precision, sterility, and regulatory compliance, Dordan delivers with unmatched expertise and dedication.
What Sets Us Apart:
ISO Certified Quality
Cleanroom Production
Full-Service Manufacturing in USA
Risk-Based Quality Assurance
Personalized, Responsive Support
4th-Generation Family-Owned Since 1962
Looking for a reliable partner for custom medical blister packaging? Contact Us or Request a Quote today to begin your project with Dordan.