Frequently Asked Questions: Medical Thermoforming

Medical thermoforming is the process of heating a thermoplastic sheet until it becomes formable, shaping it over or into a mold using vacuum, air pressure or mechanical force, and holding it in place as the material cools into the desired shape.

For medical applications, that forming process is combined with the controlled manufacturing environment, material selection, quality systems and documentation required for the specific device or packaging application.

Janco performs medical thermoforming in ISO 14644-1 Class 8 certified cleanrooms and supports projects from design and tooling through production and packaging.

The basic forming process is similar, but medical thermoforming introduces additional requirements around the manufacturing environment, material selection, quality management, documentation and traceability.

Janco’s medical manufacturing division operates under an ISO 13485 quality management system and is FDA registered. Medical thermoforming is performed in certified Class 8 cleanrooms, while Janco’s medical packaging operations include Class 7 cleanroom environments.

Janco also provides validation testing according to ASTM, ISO or customer-specific requirements depending on the application, along with traceability from individual product identification back to raw material lot numbers.

Learn more about Janco’s quality, regulatory and cleanroom certifications.

Thermoforming offers several advantages for medical device and packaging projects. Janco commonly highlights relatively low tooling costs, short lead times, quick prototype development, extensive material choices and significant design flexibility.

Because thermoformed parts are produced from plastic sheet, manufacturers can also evaluate different materials, gauges, finishes and design configurations around the needs of the device or packaging system.

The process is especially useful for custom medical trays and packaging where product retention, organization, protection and device geometry need to be incorporated directly into the design.

A typical project begins by defining the application, design requirements, materials, budget and timeline. From there, Janco can support design development, prototyping and tooling before the project moves into production.

Janco also manufactures thermoforming molds in-house using 3- and 4-axis CNC machining centers. Keeping tooling and production capabilities under one roof can help streamline communication as a project progresses from design into manufacturing.

Depending on the project, additional steps may include trimming or fabrication, cleanroom assembly and medical device packaging.

Learn more about Janco’s in-house mold making capabilities.

Janco commonly uses medical thermoforming to manufacture products and packaging such as medical device trays, blister packaging, clamshells and protective cases.

Custom thermoformed products can support medical markets including orthopedics, vascular, respiratory, endoscopy, laboratory, cardiology, ophthalmic, spinal and biologics, dental, pharmaceutical, veterinary and drug-delivery applications.

The appropriate process, material and design depend on the specific medical device or packaging requirements. Explore Janco’s broader medical contract manufacturing capabilities for additional applications.

Yes. Medical trays are one of Janco’s most common thermoforming applications.

Custom thermoformed trays can be designed around the size, shape and organization requirements of a medical device or procedural kit. Depending on the application, trays may incorporate multiple compartments, lids, peel-top configurations or other features designed around device retention, protection, handling and presentation.

Janco manufactures custom trays for applications ranging from single-use procedure packaging to specialized medical-device systems, including extended-length trays for applications requiring unusually long instruments.

Learn more about Janco’s medical device packaging trays and its guide to medical tray types and applications.

Janco works with a broad selection of plastics for thermoforming and medical packaging projects, including:

• PET, PETG and PETE
• HIPS
• Acrylic
• PVC
• Kydex®
• ABS
• Polycarbonate (PC)
• Polypropylene (PP)
• Polystyrene (PS)
• HDPE
• Thermoplastic polyurethane (TPU)
• Other materials based on the application

Janco also thermoforms several foam materials. Material selection should be based on the requirements of the individual product rather than choosing a plastic solely because it can be thermoformed.

See Janco’s overview of medical packaging materials for additional information.

There is no single best plastic for every medical thermoforming project. The appropriate material depends on the device or packaging application, required rigidity or flexibility, clarity, geometry, intended use, manufacturing process and sterilization requirements.

For that reason, a material list alone is rarely enough to make a good selection. A transparent tray, a flexible component and a rigid protective package may require very different material properties even though all three can potentially be thermoformed.

Janco works with customers during design and material selection to evaluate plastics and foams around the requirements of the specific project. If material has not yet been specified, include the intended application and performance requirements when you contact Janco about your project.

Sterilization requirements should be considered during material selection rather than after a thermoformed product or package has already been finalized.

Janco works with medical-grade materials selected around application requirements and sterilization methods that can include EO, Gamma, E-Beam, peroxide, dry heat and autoclave. The appropriate material depends on the specific product and sterilization process.

Not every thermoformable material should be assumed to be compatible with every sterilization method. Material, device, packaging and validation requirements should be evaluated together before production specifications are finalized.

The distinction primarily refers to the thickness of the sheet being formed and the type of product being manufactured.

Janco’s core thermoforming equipment accommodates material gauges from .007″ to .060″ with a 29″ × 32″ bed. Its heavy-gauge pressure-thermoforming capabilities extend up to .500″ gauge with a 48″ × 72″ bed and a depth of draw up to 24″.

Which process is appropriate depends on the geometry, size, structural requirements and intended application of the part. Janco’s engineering team can help determine which capability is better suited to a specific project.

Pressure thermoforming uses controlled air pressure to help force a heated plastic sheet against the mold surface as the part is formed.

Janco offers heavy-gauge pressure thermoforming for projects requiring larger dimensions or thicker material than its core thin-gauge thermoforming capabilities accommodate.

Janco’s heavy-gauge equipment supports a 48″ × 72″ bed, material gauges from .006″ to .500″ and a depth of draw up to 24″. In-house design assistance, prototype tooling and production tooling are also available.

View Janco’s complete medical thermoforming capabilities.

Yes. Janco performs its medical thermoforming in ISO 14644-1 Class 8 certified cleanrooms.

Cleanroom manufacturing provides a controlled environment designed to manage airborne particulate levels during production. For medical applications, the appropriate manufacturing environment depends on the product, process, packaging requirements and applicable project specifications.

Janco’s high- and low-volume thermoforming operations are Class 8 certified. Other medical processes, including packaging, assembly and foam manufacturing, are performed within Class 7 or Class 8 environments depending on the operation.

Learn more about Janco’s cleanroom medical manufacturing capabilities.

Janco uses different cleanroom classifications for different stages of medical manufacturing.

Both high- and low-volume thermoforming are performed in ISO 14644-1 Class 8 certified cleanrooms. Medical device assembly, foam die cutting and assembly, and foam molding also have Class 8 certified environments.

Janco’s medical packaging operations include an ISO 14644-1 Class 7 certified cleanroom. This allows products to move through manufacturing and packaging environments appropriate to the requirements of each operation.

Current certifications are available on Janco’s Quality & Regulatory page.

Thermoforming and injection molding are different plastic-manufacturing processes. Thermoforming starts with plastic sheet that is heated and formed over or into a mold. Injection molding forms parts by introducing molten plastic into a mold cavity.

Janco identifies short lead times, relatively low tooling costs, quick prototype development and design flexibility among the benefits of thermoforming. However, process selection should depend on the actual part geometry, material requirements, production volume, tooling requirements and performance expectations.

One process should not be considered universally better than the other. For a medical-device project, the more useful question is whether the design and production requirements are a good fit for thermoforming.

Janco’s engineering team can review your design and help determine whether its thermoforming capabilities fit the application.

The mold defines the shape the heated material will take during thermoforming, making tooling a critical part of the manufacturing process.

Janco manufactures molds in-house using 3- and 4-axis CNC machining centers. Keeping mold making within Janco’s own operation allows the design, prototyping, tooling and production teams to work more closely as the project develops.

Common projects using Janco’s mold-making capabilities include surgical trays, clamshells and blister packaging.

Explore Janco’s mold making capabilities for more information.

The appropriate certifications and quality requirements depend on the product being manufactured, but medical-device companies should evaluate whether a potential manufacturing partner has a quality system and controlled manufacturing environment appropriate to the project.

Janco Medical’s relevant credentials include:

• ISO 13485 certification
• FDA registered facility
• ISO 14644-1 Class 8 certification for high-volume thermoforming
• ISO 14644-1 Class 8 certification for low-volume thermoforming
• ISO 14644-1 Class 7 certification for medical packaging
• Additional Class 8 certifications for medical device assembly, foam die cutting/assembly and foam molding

Janco’s medical processes are also assessed through internal, independent, FDA and customer audits, and its inspection staff performs validation testing according to ASTM, ISO or customer-specific standards depending on the application.

Review Janco’s current certifications and quality information.

Janco supports both core thin-gauge thermoforming and heavy-gauge pressure thermoforming for medical applications.

Janco’s medical manufacturing division is also ISO 13485 certified and FDA registered.

See the full medical thermoforming service page for current equipment and capability information.

The more Janco understands about the application at the beginning of a project, the more effectively its engineering and manufacturing teams can evaluate the design, materials, tooling and production requirements.

Helpful information can include:

• The intended medical device, component or packaging application
• Part or tray dimensions and available drawings
• Material requirements, if already specified
• Expected production quantities
• Cleanroom or packaging requirements
• Sterilization method, when relevant to material selection
• Design or prototype status
• Project timeline and other manufacturing requirements

Janco’s project inquiry form also allows customers to upload a drawing or PDF for review.

Contact Janco Medical to discuss your project or submit drawings for evaluation.