TPE FOR MEDICAL APPLICATIONS

TPE Medical Applications
Chemiton Med

Thermoplastic elastomers for pharmaceutical and paramedical applications

Chemiton Med® is a family of compounds designed for medical, paramedical, and pharmaceutical applications. Chemiton MED® products are phthalate-free, making them lighter than PVC and any vulcanized rubber. They are also USP Class VI certified ensuring biocompatibility, and comply with all food contact regulations. These thermoplastic elastomers for the medical sector are ultra-soft and can be sterilized via autoclave, EtO, Beta, and Gamma rays, making them ideal for ensuring the highest quality and efficiency standards.

USP Class VI and ISO 10993-4-5-10-11

DMF Registration No. 027175

A valid alternative to vulcanized rubber, silicone, and PVC

TPE - paramedical applications
TPE Pharmaceutical Applications
TPE - Pharmaceutical

Translucent TPE

The translucent Chemiton Med® compound is the ideal TPE for paramedical and pharmaceutical applications. It can be used to create a variety of soft-touch components for medical use, such as injection sites, twist-off closures, connectors, peristaltic pump tubing, stoppers, seals, valves and membranes, providing an excellent alternative to silicone.

The material passes tests for hemolysis, cytotoxicity, intracutaneous reactivity, and acute systemic toxicity. It is also suitable for producing intramuscular implant devices and it is registered with the FDA under DMF.

  • Based on hydrogenated styrenic block copolymers (HSBC)
  • Translucent
  • Matte, good surface finish
  • Processable by injection molding, extrusion, or film blowing
  • Good adhesion to polyolefins
  • Low compression set
  • Wide operating temperature range
  • Resistant to aging, UV rays, and ozone
  • Hardness: from 30 Shore A to 95 Shore A
  • Density: 0.89 g/cm³
  • Free from PVC, phthalates, and latex
  • Compliant with USP Cl VI, ISO 10993-4, ISO 10993-5, ISO 10993-10, and ISO 10993-11
  • Compliant with 10/2011/EC (excluding fatty and/or oily foods), FDA, 1907/2006/EC REACH Annex XIV and XVII, ROHS, RAEE, WEEE, ELV, EN71/3

Gray Perforable TPE

Thermoplastic elastomers from the gray perforable range are primarily used for single-use perforable pharmaceutical closures. With excellent resealing properties, these features make this thermoplastic material ideal for producing pharmaceutical and paramedical packaging, such as penicillin vial caps, injectable antibiotic stoppers, perforable membranes, seals and gaskets.

The material passes tests for hemolysis, cytotoxicity, intracutaneous reactivity, and acute systemic toxicity, and is also suitable for producing intramuscular implant devices.

  • Based on hydrogenated styrenic block copolymers (HSBC)
  • Gray color
  • Excellent surface finish
  • Processable by injection molding
  • Good adhesion to polyolefins
  • Excellent resealing
  • Wide operating temperature range
  • Resistant to aging, UV rays, and ozone
  • Developed with a hardness value of 55 Shore A for this specific application
  • Density: 0.89 g/cm³
  • Free from PVC, phthalates, and latex
  • Compliant with USP Cl VI, ISO 10993-4, ISO 10993-5, ISO 10993-10, and ISO 10993-11
  • Compliant with 10/2011/EC (excluding fatty and/or oily foods), FDA, 1907/2006/EC REACH Annex XIV and XVII, ROHS, RAEE, WEEE, ELV, EN71/3

TPE for Cosmetic Use

Chemiton Med® compounds developed for cosmetic use exhibit extremely low migration levels when in contact with simulant D2 (olive oil), ensuring excellent chemical resistance to oily substances in the cosmetic and pharmaceutical sectors. Their transparency, easy colorability and flexibility make them an excellent choice for producing items intended for the healthcare and beautycare industries. These compounds are entirely safe for skin contact, meet food contact regulations and are free from PVC and plasticizers.

The material passes tests for hemolysis, cytotoxicity, intracutaneous reactivity, and acute systemic toxicity, and is also suitable for producing intramuscular implant devices.

  • Based on hydrogenated styrenic block copolymers (HSBC)
  • Crystal-clear transparency
  • Excellent surface finish
  • Processable by extrusion
  • Good adhesion to polyolefins
  • Extremely low migration levels when in contact with oily substances
  • High resistance to alcohols
  • Wide operating temperature range
  • Resistant to aging, UV rays, and ozone
  • Hardness: from 50 Shore A to 45 Shore D
  • Density: 0.89 g/cm³
  • Free from plasticizers, PVC, phthalates, and latex
  • Compliant with USP Cl VI, ISO 10993-4, ISO 10993-5, ISO 10993-10, and ISO 10993-11
  • Compliant with 10/2011/EC, FDA, 1907/2006/EC REACH Annex XIV and XVII, ROHS, RAEE, WEEE, ELV, EN71/3

Low Permeability TPE

Thermoplastic elastomers characterized by low gas permeability are a valid alternative to halobutyl vulcanized rubbers like bromobutyl and chlorobutyl. Their excellent oxygen permeability makes these materials ideal for applications requiring a low OTR (Oxygen Transmission Rate), such as certain pharmaceutical and food closures or vacuum seals. The material passes tests for hemolysis, cytotoxicity, intracutaneous reactivity, and acute systemic toxicity.

  • Based on hydrogenated styrenic block copolymers (HSBC)
  • Natural color, easy to color
  • Excellent surface finish
  • Processable by injection molding and extrusion
  • Good adhesion to polyolefins
  • Extremely low gas permeability, especially oxygen (low OTR)
  • Low water vapor permeability (low WVTR)
  • Resistant to aging, UV rays, and ozone
  • Hardness: from 55 Shore A to 90 Shore A
  • Density: from 1.25 g/cm³ to 1.29 g/cm³
  • Free from PVC, phthalates, and latex
  • Compliant with USP Cl VI, ISO 10993-4, ISO 10993-5, ISO 10993-10, and ISO 10993-11

TPE for Film Blowing

These SEBS-based TPE compounds are ideal for bubble filming of thin elastic films. The material has an opaline/translucent or transparent appearance and can be mixed with anti-slip and anti-lock release agents. Its colorability and processability are similar to those of polyethylene film.

This thermoplastic material is suitable for the production of single-layer elastic film for surgical drapes. It is also used to enhance the properties of polyolefin-based adhesive films in personal care and hygiene applications, such as for baby and elderly diapers. The material passes tests for hemolysis, cytotoxicity, intracutaneous reactivity, and acute systemic toxicity.

  • Based on hydrogenated styrenic block copolymers (HSBC)
  • Opaline/translucent or transparent
  • Excellent surface finish
  • Easy processing by film blowing, coextrusion with all the polyolefins of the field
  • Colorability and workability similar to that of PE film (processing temperatures between 150°C and 200°C)
  • With anti-blocking sliding/release additives
  • Resistant to aging, UV rays, and ozone
  • Hardness: from 40 Shore A to 75 Shore A
  • Density: from 0.87 g/cm³ to 0.95 g/cm³
  • Free from PVC, phthalates, and latex
  • Compliant with USP Cl VI, ISO 10993-4, ISO 10993-5, ISO 10993-10, and ISO 10993-11

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