Medical Products Supplies Companies

Gamla Ornasgatan 15, 66222 Amal
Sweden
Telephone +46 532 607500
Fax +46 532 607599
mediprene@hexpoltpe.com
http://www.hexpoltpe.com

Product Categories

Product categories

08 Raw materials, materials, adhesives
08.01 Plastics
Plastics

Our products

Product category: Plastics
Mediprene 500M
Mediprene 500M standard series

The Mediprene 500M range encompasses our original medical TPE grades. They are available in hardnesses from 0 Shore A to 62 Shore D. With translucent and transparent grades, they are also easy to colour.

Mediprene grades are sterilizable with gamma, EtO and steam and representative grades have passed cytotoxicity tests according to ISO 10993-5 and biocompatibility tests according to ISO 10993-4 (Hemolysis), ISO 10993-10 (Intracutaneous Reactivity), ISO 10993-11 (Acute Systemic Toxicity) and USP Class VI. Mediprene TPEs have proven to be a strong alternative as replacement to PVC; they are completely synthetic and latex free thereby minimizing allergy risks.

The right TPE formulation is the key to a safe and successful medical product. When a standard formulation does not meet the needs of a unique application, we will formulate a custom solution.

Special Features

Flexibility and elasticity
0 Shore A to 62 Shore D
Translucent grades
Soft-touch appeal
Excellent resistance to many fluids used in the healthcare environment
PVC, silicone & latex free
Adhesion to PP or PE in 2K applications
Easy to process with short cycle times
Sterilizable with autoclave, EtO and Gamma irradiation
ISO 10993-5 and USP Class VI compliant
Production site accredited to ISO 9001, 14001 and 13485

Applications

Soft-touch grips
Resealable membranes
Airway management
Face masks
Connectors
Medical packaging
Wound care

Product category: Plastics
Mediprene 500M for Syringe Plunger Seals
Mediprene TPE for Syringe Plunger Seals

We have developed a range of Mediprene thermoplastic elastomers (TPE) for plunger seals in single-use syringes. The TPE seal, which is mounted on the end of the plunger, needs to provide a leakproof seal with the syringe barrel. As ease of use for the medical practitioner and patient comfort are also key requirements, the seal helps to optimize plunger movement for accurate dosage control and ease of injection.

Originating from medical raw materials with high biocompatibility status and compounded under clean conditions, Mediprene TPEs are the material of choice for medical customers who want to maximize the probability that their devices will pass relevant medical tests.

All Mediprene TPE Syringe Plunger Series compounds fulfil a strict raw material selection policy. The raw materials are food contact compliant (FDA 21CFR and Commission Regulation (EU) No 10/2011) and have a proven level of biocompatibility:

The styrenic block copolymer has passed USP Class VI
The paraffinic oil is a medicinal white oil complying with the EP for liquid paraffin and USP 24 for mineral oils
The PP has passed the USP Class VI tests and meets the requirements in the EP Monograph 3.1.3 Polyolefins
The components of the black masterbatch have passed USP Class VI or corresponding parts of ISO 10993

Product category: Plastics
Mediprene 500M Transparent TPEs
Transparent TPE Compounds for Medical Applications

The Mediprene 500M range of TPEs for medical applications includes several transparent grades. These compounds were developed in response to an increasing interest in transparent compounds from the medical market.

Mediprene TPE materials are PVC, silicone and latex free, making them allergen free and a viable alternative to PVC based compounds. They offer hardnesses from 30 to 90 Shore A, allowing a wide degree of design freedom.

Special Features

Good transparency
PVC, silicone and latex free
Soft-touch appeal
30 to 90 Shore A
Coloured, transparent grades
Production site accredited to ISO 13485
Sterilizable with gamma, ethylene oxide (EtO) and steam
Flexibility over broad temperature range
Excellent sealing and adhesion
Applications
The ability to clearly see through a product to monitor the patient is an important feature for many medical devices such as face masks. Transparent TPEs can also be used in tubing and dental applications.

Coloured & transparent
In medical devices and pharmaceutical packaging colour is also often used functionally for product identification, to differentiate products with different uses or sizes.

The vibrant colours achievable with coloured Mediprene TPE compounds allow brand owners to add value to their products and create visual appeal. A blue or green colour is often used in medical transparent or translucent products to disguise the yellowing phenomena that can be caused by for example gamma sterilization.

The coloured transparent compounds are made from medical grade raw materials only. The colour masterbatch supplier has been selected with care, ensuring that not only the colorants and carriers are compliant with USP Class VI or corresponding parts of ISO 10993 but also that the masterbatches are manufactured under rigorous controls with regard to traceability, consistency and change control, thereby fitting the Mediprene concept at our ISO 13485 accredited facilities.

Colour consistency
A fully colour compounded TPE gives a perfectly dispersed, consistent colour with a correct and reproducible addition level. Mediprene coloured transparent compounds ensure colour reproducibility and deliver a compound ready for use, with no additional steps for the moulder or extrusion company.

Product category: Plastics
Mediprene OF
Mediprene OF – Oil Free TPE Compounds for Medical Applications

The Mediprene Oil Free range was developed to address demands for transparent medical TPEs with a minimum of potential extractables and leachables.

The Mediprene OF range helps to prevent the possibility of oil migrating or leaching out of the material, a key requirement for medical and healthcare-related devices. They are ideal for sensitive medical applications where transparency is also required.

Special features:

Minimum of potential extractables & leachables
PVC, silicone & latex free
Soft-touch appeal
40 Shore to 40 Shore D
Transparent & Crystal Clear Grades
Anti-kinking
Sterilizable with gamma, ethylene oxide (EtO) and steam
Excellent sealing & adhesion
The Mediprene OF grades are also highly suitable for medical tubing. They have a high level of transparency, allowing for clear visibility of the passage of liquids and anti-kinking properties to ensure the free flow of liquids and gasses through the tubing.

We also offer grades which display good damping properties, thereby slowly recovering after deformation like PVC, an important element in catheter tubing design. For catheter applications, the tubing is often coated in order to achieve a low-friction surface, Mediprene TPE compounds have been successfully modified for better wettability and adhesion of such coatings.

Hot melt adhesives (for example for connections) adhere well to the Mediprene OF range. These compounds show excellent performance with double-coated tapes for ‘stick to skin’ applications such as patches for fixation of tubing or other medical components.

Product category: Plastics
Mediprene A
Mediprene A – TPE for medical two component applications

Overmoulding is a powerful technique that allows the production of finished parts in soft and hard material combinations without trimming or assembly.

It offers many design and product advantages, allowing designers to differentiate products while meeting important user and patient demands, including soft-touch and cushioning for greater comfort and non-slip surfaces with improved grip for safety.

The 500M Mediprene range bonds very well to polyolefins like polyethylene (PE) and polypropylene PP). However, in several medical applications transparent engineering plastics like ABS, PC, PETG and SMMA (and their blends) are utilised. The Mediprene A2 series has been developed to address demands for medical grade TPEs that bond well to these substrates.

Special features

Unfilled
PVC, silicone & latex free
35 to 65 Shore A
Flexibility over broad temperature range
Resistant to many fluids used in the healthcare environment
Sterilizable with gamma, EtO and steam
Production site accredited to ISO 13485
Potential applications for the Mediprene A range include: seals, membranes, closures, friction grips, soft-touch handles. Mediprene TPEs provide enhanced sealing capabilities in fluid environments.

Product category: Plastics
Mediprene BM
Mediprene BM – TPE for Blow Moulding Applications

Introduction
Mediprene BM is a range of thermoplastic elastomers (TPE) optimised for medical blow moulding applications.

What is blow moulding?
Blow moulding is a manufacturing process that is used to produce hollow parts such as bottles, balloons and bags. The process begins with melting the TPE and forming it into a tube, called a parison. The parison is clamped into a divided mould, the tube is pinched at one end, welding it together and then air is blown into it. The air pressure inflates the TPE out to match the mould cavity. Once the TPE has cooled and hardened the mould opens and the part is ejected.

Mediprene BM TPE
We have designed the Mediprene BM TPE compounds to have high melt strength, giving time to close the mould around the extruded parison while allowing sufficient stretchability during inflation. They also offer good welding in the pinchoff area of the blow mould. They can easily be coloured and give a smooth surface to the finished part.

Applications
The TPE can be blow moulded into products with thin walls requiring a soft-touch feel with high levels of flexibility and durability.

Special features

PVC, silicone and latex free
High melt strength
Excellent flexibility and stretchability
Soft-touch appeal
Different Shore A hardnesses available
Production site accredited to ISO 13485
Sterilizable with gamma, ethylene oxide (EtO) and steam
Smooth surface finish
Easy to colour

Product category: Plastics
Mediprene – Coloured TPE Compounds
Coloured Mediprene Compounds

Our coloured Mediprene compounds are made from medical grade raw materials only, thereby representing a natural expansion of our Medical TPE product range.

The colour masterbatch supplier has been selected with care, ensuring that not only the pigments and carriers are compliant with USP Class VI or corresponding parts of ISO 10993 but also that the masterbatches are manufactured under rigorous controls with regard to traceability, consistency and change control thereby fitting the Mediprene concept at our ISO 13485 accredited facilities.

In medical devices and pharmaceutical packaging colour is often used functionally to differentiate products and provide an easy method of identification. The vibrant colours achievable with coloured Mediprene compounds also give brand owners a means of adding value to their products and creating visual appeal.

A fully colour compounded TPE gives a perfectly dispersed, consistent colour with a correct and reproducible addition level. Mediprene colour compounds ensure colour reproducibility and deliver a compound ready for use, with no additional steps for the moulder or extrusion company.

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About Us

Company details
About Us

WHO WE ARE
HEXPOL TPE is a global polymer compounding group specialising in Thermoplastic Elastomers (TPE). We are proud to be part of the HEXPOL family.

WHAT WE DO
Our products add value, functional performance and soft-touch aesthetics to a growing number of applications in the consumer, medical, packaging, electronics and construction markets.

HOW WE DO IT
We have a core belief in being the easiest company to do business with. This is what drives us and it’s why we invest in our operations, teams and technologies to ensure we give our customers the most reliable, relevant and cost-effective TPE compounds, backed by highly responsive support, technical know-how and application expertise.

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