Uses of Heat Sealing on Medical Devices

Between space and medicine, you’d be hard-pressed to find a more regulated industry. This makes sense as these industries contain many of the same dangers. In space, vacuum tight seals are important for survival.

In medical devices, having precisely measured seals can also mean life and death, so regulations are just as stringent. The many different applications of heat seals in the industry (such as ports & plates) require the highest standard of equipment manufacturing to deliver consistent, validated results.

Wearable Medical Devices

When it comes to monitoring patient health or delivering essential medicine automatically through a wearable medical device, comfort is a primary factor. The heat sealing on a wearable devices shouldn’t have any sharp or hard edges, which was a big limitation with technologies of the past.

Using heat sealing for the manufacture of adhesive patches, pouches or pumps, both internal and external applications become possible. Not only does it improve the patient’s experience, but you can also reduce the time to manufacture the devices.

Medium and Sample Separation

Laboratories must perform analysis under strict controls that ensure sampling remains uncontaminated. This may require sealing the containment vessels for transport or storage, without impeding the collection of samples.

Thermal Press machines and heat sealing technologies provide measurement and recording options and mechanisms that are used for demonstrable compliance. With different tool sets to accommodate different laboratory standards, a thermal press heat seal will usually not be far away.

Port Sealing & Welding

A critical component of wearable medical devices are the medical ports, plates &/or boat fitments sealed on the medical bags &/or pouches themselves. These ports require hermetic sealing under rigorously controlled conditions. Coming in standard shapes and sizes means the heat seals require specific dies or blades designed to work with the specific ports, tubes, fitments and plates.

Medical Device Compliance Requirements

Measuring device seal compliance is critical in the medical field. Any system that manufactures the bags and pouches, port seals and filter media, needs to provide validated production reports. The laws governing their manufacture come from the FDA, USDA, and USP regulatory bodies.

The regulations and standards determine the types of plastics used in the devices as well as the seal strength required for each application. Record keeping, device calibration, and certification are all required when using hot sealing to manufacture medical grade equipment.

Thermal Press Heat Sealers Provide Validated Joints for the Medical Industry

Thermal Press provides machines and optional devices that are adaptable to many different solutions and automation cells. Our thermal sealing and welding systems are suitable for any type of quick, consistent heat sealing requirement. For stringent regulatory environments, our machines have precise and field calibratable digital controls for velocity, temperature, pressure and force.

Thermal Press has many additional machine options and upgrades; including Servos and other precision assembly devices to ensure the assembly process has the highest level of control to produce reliable, repeatable and validated results.

If you need a partner to help build a manufacturing process that requires medical grade heat sealing technology, contact Thermal Press today to discuss your requirements.