Medical devices with TPE's soft-touch advantage

KRAIBURG TPE provides the THERMOLAST® M TPE compounds for a soft-touch feel and surface in medical device applications. With accuracy and precision, medical devices, whether used in a home or in a healthcare setting, are expected to provide effective outcomes for a patient. The design of the instruments must, thus, be ergonomically driven to enable dexterity, control and comfort when handling the instruments.

A soft-touch surface promotes ease of use, and better control and grip, especially in hand-held or single-use medical devices. For self-administering in the home, a soft-touch surface can ensure proper and easy handling of medical devices for effective drug delivery and error-free performance.

Today, thermoplastic elastomers (TPEs) are widely used for a soft-touch surface and feel. Moreover, the varied mechanical properties of TPEs in medical device applications, such as ease of coloration, flexibility and purity, contribute to the aesthetic appearance and high usability of the products. For manufacturers, TPEs are the perfect choice of materials, owing to their easy processing, for example, via injection molding or extrusion process.

KRAIBURG TPE, a global TPE manufacturer of a wide range of thermoplastic elastomer products and custom solutions for multiple industries, offers high quality and custom-engineered THERMOLAST® M compounds that conform to the soft-touch requirements of medical device applications.  

Taking a safe approach

For soft-touch surfaces in medical device applications, KRAIBURG TPE offers the THERMOLAST® M MC/AD/PA series of compounds that are sterilizable by using methods such as EtO gas, γ-gamma ray treatment (2 x 35 kGy) and β-ray (electron beam) treatment (2 x 35 kGy). The THERMOLAST® M series is also free of latex, PVC and phthalates, allowing it to be used for medical devices.

The THERMOLAST® M has been specially formulated for applications requiring medical approvals and conforms to standards such as ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Intracutaneous irritation).

The MC/AD/PA compounds have excellent adhesion to various polyamides such as PA6 and PA12, allowing for use in applications requiring soft-touch grips, sealing, flexible connectors, switches, and mats in the medical devices industry. The compounds can also be applied in handles, buttons and closures that require soft-touch surfaces for medical devices. The compounds can be coloured in various options using Pantone and RAL as a colour reference, allowing for differentiation of end products.

Approved to exacting standards

KRAIBURG TPE’s THERMOLAST® M MC/tl series is certified to standards such as ISO 10993-10 (Intracutaneous irritation), ISO 10993-5 (Cytotoxicity), ISO 10993-4 (Hemolysis), ISO 10993-11 (Acute systemic toxicity) and VDI 2017.   

The MC/tl series has optimised compression set and has excellent abrasion resistance, for applications that require high contact and friction such as handles and grips on medical devices and sealings on respiratory masks.

KRAIBURG TPE strives to maintain the standards of its products by providing a service package that focuses on customer needs. It does this by constantly recording the manufacturing process in the drug Masterfile (DMF); and by guaranteeing 24-month supply security and purity of raw materials through the commitment of suppliers. It also has a dedicated production unit for the manufacture of THERMOLAST® M to ensure quality, safety and reliability of the compounds.