The Exolon Group presents to you a wide range of transparent solid sheets to be used in the medical field. We are a leader of extruded thermoplastic sheets that can be used in diverse and innovative applications.

Thermoplastic sheets for medical devices by Exolon Group

Our products are processed in high quality. And that offers the medical sector an ideal condition to use them. The materials we use are both transparent and temperature-resistant. They also have extreme impact strength. This helps us ensure universally safe solutions for manufacturers in both the medical and healthcare sectors.
Exolon Group’s products offer you quality, safety and traceability. Whether you need them for containers, dental aligners, protheses or rigid medical packaging.

Transparent sheets to produce rigid medical packaging

Not every material is suitable for the fabrication of products for the medical field . There are high standards for medical products, both legal and qualitative. The end product and its benefits are the deciding factors for approval. Every medical device is assessed and tested by regulatory authorities before it is considered safe for sales and marketing.

This is also where we come into the picture. At Exolon Group, we have many years of experience, competence and knowledge in the development of high-quality plastic sheets. And so, we manufacture products of the best quality.
For more information on the use of products by the Exolon Group, especially in medical technology, please refer to our medical reference manual.

Plastics in medical packaging

In medical packaging, plastics play an important role. For example, sheets made of polycarbonate or copolyester are all crucial to medical packaging, depending on their impact strength and transparency. Examples are transport boxes for prostheses or implants or trays for medical instruments. You can also read about our infection protective plastic sheets here. Apart from these, you can find more information on our Med sheets below.

Exolon Group´s medical plastic sheets meet biocompatibility requirements according to ISO 10993/ USP Class VI

Our transparent sheets are made of resins which meet the requirements of ISO 10993/ USP class VI. You need the ISO certificate as a quality indicator to prove the biocompatibility of materials for medical devices. For all materials of Exolon Group the biocompability can be proven and therefore the materials can be used without doubt in the medical field. We can document the traceability down to the original resin used.

What does the ISO 10993 standard state? 

The ISO 10993 certificate is required as a quality indicator to prove the biocompatibility of materials for medical devices. The standard describes biological risks much more precisely and comprehensively.

Benefits of Exolon Group‘s sheets in the medical field:

• Safety and efficacy: Our products are safe and effective. They help you comply with the new EU MDR (Medical Device Regulation)⁽¹⁾ in terms of reliability and traceability for rigid packaging and thus position the product on the market in less time.
• Traceability: Processors can trace our sheet material down to the raw material. This is an important basis for further documentation of future end products.
• Quality: All Med-Range products consist of 100% virgin material. This material meets the requirements of ISO 10993⁽²⁾ for the biological evaluation of medical devices.
• Versatility: Our products are suitable for producing rigid medical packaging, containers and/or dental aligners.
• Impact resistance: High resistance of the materials is granted thanks to the material´s impact strength. The transported product is securely protected from external factors
• Temperature resistance: Strong heating does not cause difficulties for the materials we use.
• Good Manufacturing Practice: The Good Manufacturing Practice (GMP) ensures that medical devices are manufactured in compliance with high quality standard.

(1) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
(2) What does the ISO 10993 standard state? The ISO 10993 certificate is required as a quality indicator to prove the biocompatibility of materials for medical devices. The standard describes biological risks much more precisely and comprehensively.

Exolon® Med

Exolon® Med are transparent polycarbonate solid sheets. The material is the ideal plastic for medical technology and has high impact strength. In addition, its heat resistance allows the material to be processed at up to 120 degrees.
 
The application of Exolon® Med extends to the following medical fields:

• Rigid medical packaging.
• Containers and trays for medical devices.
• Applications with skin contact (e.g. protheses).
• Transparent protective devices on medical devices.

Vivak® Med

Vivak® Med is manufactured from Eastman EastarTM 6763 and are transparent, thermoplastic copolyester sheets. They combine impact strength with excellent thermoforming properties and good transparency.
As a process, thermoforming consumes low energy, has short production cycles and extreme elongation levels. This also includes accurate reproduction of the mold surface without pre-drying. The sheets are easy to machine too.
 
The application of Vivak® Med extends to the following medical fields:

• Rigid medical packaging.
• Containers and trays for medical devices.
• Applications with skin contact (e.g. protheses).

Inspria® Med

Inspria® Med are made of Eastman TritanTM MP100 and are transparent, highly heat-resistant copolyester sheets. They combine good heat resistance up to 90° C with excellent thermoforming properties and good transparency. Thanks to the high impression reproducibility, this is an excellent material for dental aligners. However, they are also highly suitable for various sterilization methods, including gamma radiation and ethylene oxide.
 
The application of Inspria® Med extends to the following medical fields:

• Dental aligners
• Rigid medical packaging applications
• Medical device containers and trays