Thin Gauge Thermoforming for Medical Device Packaging

Thin Gauge Thermoforming for Medical Device Packaging

As a thermoforming manufacturer based in southern California, Tru-Form Plastics provides specialized, professional thin and heavy gauge thermoforming services to customers seeking high-quality custom solutions. To learn specifics about different thermoforming types, visit our blog Heavy Gauge vs. Thin Gauge Thermoforming: Which Process is Right for Your Project? 

Thin gauge thermoforming refers to a plastic forming technique for creating parts from thermoplastic sheet materials with a starting gauge thickness of .012 – .040 inches. The process involves heating a plastic sheet to increase its pliability, shaping it around a male or female mold using vacuum and pressure, then trimming the excess for a finished product.  


Creating High-Performance, Medical Grade Thermoformed Packaging 

Various industries widely use thin gauge thermoforming for disposable or recyclable packaging materials. The medical industry, specifically, uses thin gauge thermoforming as a packaging solution for medical devices. The most common types of materials used for medical device packaging are PETG, High Impact Polystyrene, and Polycarbonate.  

Tru-Form utilizes our in-house engineering resources and tool shop to construct our own molds and trimming fixtures, allowing us to closely manage customer projects. Through our thermoforming applications, the Tru-Form team of experts serves the medical industry by producing medical device packaging such as: 

  • Trays for devices like catheters, implants, and orthopedic products 
  • Diagnostics test kits 
  • Transfer trays for manufacturing and automation 
  • Custom packaging trays up to 96 inches in length  
  • Special-purpose inserts for multi-purpose/configuration packaging  


Benefits of Thin Gauge Medical Device Packaging

Thin gauge thermoforming is best suited for medical device packaging for several reasons: 

  1. Design flexibility and customization. Due to strong material compatibility and various customization options for shape, size, and other features, thin gauge thermoforming allows us to closely uphold the integrity of customer product designs. 
  2. Regulation compliance. Thin gauge medical packaging can be designed to conform to industry standards and to meet specific regulatory requirements. The packaging can incorporate and benefit from FDA-approved materials and protocols for sterility.   
  3. Sterility. Our trays provide flexibility and cleanliness through the protective materials and sealing methods that help prevent contamination. Once packaged, the products are isolated for storage and shipping.  
  4. Environmental impact. While it is unsafe to recycle content from medical packaging, the plastics industry continues to set alternative goals to achieve sustainability in production. The overall aim is to reduce waste by using thermoforming to create lightweight solutions that require less materials without compromising on safety, sterility, or ease of transportation and storage.  


Driving Improvement Through Innovative Thermoforming Technology

Improvement and innovation go hand-in-hand. Given the existing advantages of thin gauge thermoforming, there is already a strong foundation from which the industry can improve efficiency, sustainability, and versatility. Tru-Form’s most recent innovative additions include our match-metal tooling capabilities with in-line trim press, which ensures a precise finish for customer products.  


Tru-Form’s Commitment to Customers 

Customer Satisfaction

Tru-Form’s creed is ensuring customer satisfaction since 1959. Our teams maintain a consistent and clear line of communication with customers to encourage the free exchange of ideas, whether it be via telecommunications or on-site visits. Our team closely collaborates with customers in the development process to first understand their needs and then develop solutions to deliver upon their needs.  


Quality Assurance

As an AS91000/ISO registered facility, Tru-Form operates and maintains a quality system to implement safeguards throughout the development process. All new projects cycle through our quality system, which begins with process and tooling verifications before moving to in-process inspections and SPC/SQC administration, then concluding with validation.  


Creative, Resourceful Solutions

Not only do we oversee customer projects from start to finish, but we go the extra mile to provide design solutions when others can’t. A customer of Tru-Form needed one million thermoformed insert trays to hold diagnostic test components. This tray required the implementation of a special post-forming trim operation for an internal part feature. No other thermoforming companies could duplicate this product design. Tru-Form, however, sourced the specialized match-metal tooling from an allied discipline in the sheet metal industry to fulfill the job. Ultimately, the resourcefulness and dedication of the Tru-Form team allowed us to meet all customer needs and implement a high-speed canopy trim press to create their desired product. Above all else, Tru-Form Plastics prioritizes being an asset to customers by filling the market gap for quality plastic packaging solutions.