Frequently Asked Questions: Medical Thermoforming

Quality, precision, and innovation are essential components of the medical thermoforming process.

From design and tooling through to production, thermoforming is all about choosing the right details to bring your project to the life – the most effective design, the ideal material selection, and a quality cleanroom to conduct the process. At Janco, we work with you to ensure that you’re adding value to your product through every stage of the process.

Below, we’re breaking down the most common questions around thermoforming, from the very basics, to how we operate in our facilities.

What is the thermoforming process?

​​Thermoforming is an essential medical manufacturing capability, used across a range of important projects for several medical sectors. It entails the process of heating a thermoplastic sheet until it is malleable, stretching that sheet either into or over a single-sided mold, and then holding that position as it cools and solidifies into the desired shape.

Once this is done, the sheet is clamped into a custom holding device and heated by an oven using either convection or radiant heat until softened.

Next, the sheet is held over a mold and pressed into or stretched over the mold using vacuum pressure, air pressure, or mechanical force. The sheet, once softened, conforms to the shape of the mold and is held in place until it cools, and any excess material is removed.

What are the benefits of thermoforming?

Several key benefits make thermoforming an ideal means of manufacturing so many products. Two of the primary benefits are the low tooling costs and short lead times, meaning clients can get quality products at an ideal price and with a quick turnaround.

That fast production time includes quick prototype development, allowing for any necessary tweaks to be made quickly before a product goes into production.

Other useful benefits include:

• A large selection of colored plastics
• Extensive finish options, including several patterns and textures
• The ability for clients to have extensive design input

What are the stages of thermoforming?

Our team has a thorough process for every manufacturing capability utilized in our facilities, including thermoforming. Typically, we start by getting a general idea of your needs, including a budget, timeline, materials, and design ideas.

Once a budget and timeline are agreed upon, we begin the design phase. In some cases, clients come to us with specific design needs, whereas others will rely on our team of engineers for help coming up with the right design for their unique needs.

Once the design is settled, we begin prototyping and tooling, building the components and machinery used for production, including custom molds. After prototyping and tooling are complete, your product will go into production. The final step is shipping the product out to you once it’s ready to be used.

Is thermoforming used for medical trays?

Yes, medical trays are one of our most common medical thermoforming projects. In addition, we also commonly manufacture blister packaging, clamshells, protective cases, and more.

Is thermoforming done in a cleanroom?

Our team thermoforms all medical products in our ISO 14644-1 Class 8 certified cleanrooms. To ensure safety and precision on every single job, our medical processes are audited regularly via independent, internal, and FDA inspections. In addition, our cleanrooms are regularly tested to ensure that they are always operating correctly and efficiently.

Our certifications include:

• High Volume Thermoforming ISO 14644-1 Cleanroom Certification-Class 8
• Low Volume Thermoforming ISO 14644-1 Cleanroom Certification-Class 8

What material is used for thermoforming?

• PET, PETG, PETE (polyethylene terephthalate)
• HIPS (high impact polystyrene)
• Acrylic
• PVC (polyvinyl chloride)
• Kydex®, a trademarked acrylic/PVC alloy
• ABS (acrylonitrile butadiene styrene)
• PC (polycarbonate)
• PP (polypropylene)
• PS (polystyrene)
• HDPE (high-density polyethylene)
• TPU (thermoplastic polyurethanes)
• TPO Foams (thermoplastic olefins)
• And others, depending on your application

What are your thermoforming capabilities?

Janco’s Core Thermoforming Capabilities

• Bed size: 29″x 32″ gauge range of .007″ to .060″
• Thermoforming and Fabrication Cleanrooms certified to ISO 14644-1 Class 8
• Fully-automated inline thermoforming machines

Heavy Gauge Pressure-Thermoforming

• Bed size 48″ x 72″, Gauge range of .006″ to .500″ with 24″ depth of draw
• In-house design assistance, prototype, REN, and production tooling
• ISO 13485 Certification, FDA Registered
• Thermoforming and Fabrication Cleanrooms certified to ISO 14644-1 Class 8

Medical Thermoforming with Janco

Thermoforming is an essential component of medical manufacturing, and you need a team you can trust to help you add value to your projects.

For six decades, Janco has been that team. We help bring clients’ visions to life using innovative technology, trusted processes, and high-quality materials at an unbeatable cost.

We work with you through every step of the process, from design through to shipping, guaranteeing that you have a trusted guide to help complete your projects with the care that they deserve. Whether you have a clear vision or need some guidance, we’re here to help.

Have a project in mind or want to learn more about our medical thermoforming process? Our team is happy to talk.