Medical and pharmaceutical applications; elasticity at high hardness; adhesion to PP

Processing Method:
Injection Molding
Color / RAL DESIGN:
transparent
 
 
Availability:
Globally
Manufacturing Site:
Germany

Typical applications

  • Squeeze bottles
  • Luer lock
  • Drip chamber
  • Closure caps

 

Material features

  • Adhesion to PP
  • Elasticity
  • Transparency
  • Stiffness
  • Sterilizable (autoclave 134°C, ß-/y-radiation 2x35 kGy, EtO)
  • Weldable (Ultrasonic)
  • Free from animal ingredients
  • US DMF listed
  • KRAIBURG TPE Medical Service Package
  • ISCC PLUS ready (mass balance approach)

 

Regulations / Approvals

  • Regulation (EU) No 10/2011
  • US FDA CFR 21 (raw material conformity)
  • VDI 2017
  • ISO 10993-4 (Hemolysis)
  • ISO 10993-5 (Cytotoxicity)
  • ISO 10993-10 (Intracutaneous injection)
  • ISO10993-11 (Acute systemic toxicity)
  • USP <88> (Biological Reactivity, Class VI)

 

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Value Unit Standard
Hardness 52 Shore D DIN ISO 48-4
Hardness 97 Shore A DIN ISO 48-4
Density 0.900 g/cm3 DIN EN ISO 1183-1
Tensile Strength1 18.0 MPa DIN 53504/ISO 37
Elongation at Break1 550 % DIN 53504/ISO 37
Tear Resistance 100.0 N/mm ISO 34-1 Method B (b) (Graves)
CS 72 h/23 °C 52 % DIN ISO 815-1 Method A
CS 24 h/70 °C 79 % DIN ISO 815-1 Method A
1Deviating from ISO 37 standard test piece S2 is tested with a traverse speed of 200 mm/min.
All values published in this data sheet are rounded average values.
The expected shelf life of the TPE granules is a minimum of 24 months from the date of delivery, provided that the storage instructions are followed and the product is kept in the unopened original KRAIBURG TPE packaging. Dry conditions at room temperature (below 40 °C/ 104 °F), away from heat sources and direct sunlight, must be maintained for proper storage. Contact with nitrogen oxides during storage should be avoided.
For further information and individual custom solutions please contact our customer service.

Processing Guideline Injection Molding
Cylinder Temperature 180 - 200 - 220 °C, max. 250 °C (360 - 390 - 430 °F, max. 480 °F)
Hotrunner Hot runner temperatures: 200 -250 °C (390 - 480 °F). The runner should be empty after a maximum of 2 - 3 shots.
Injection Pressure 200 - 1000 bar (2900 - 14504 psi) (depending on the size and weight of the part).
Injection Rate In general, the fill time should not be more than 1–2 seconds.
Hold Pressure We recommend to derive the optimum hold pressure from determining the solidification point, starting with 40 % - 60 % of the required injection pressure.
Back Pressure 20 - 100 bar; if color batches are used, higher back pressure is necessary.
Screw Retraction If an open nozzle is used processing with screw retraction is advisable.
Mold Temperature 25 - 40 °C (77 - 104 °F)
Predrying Pre drying of the material is not necessary; if surface moisture forms as a result of changes in temperature, the material should be dried for 2 - 4 hours at 60 - 80 °C (140 - 175 °F).
Needle Valve With materials < 50 Shore A the use of a needle valve is advisable.
Screw Geometry Standard 3-zone polyolefine screw.
Residence Time The residence time is to be set as short as possible with a maximum of 10 minutes.
Cleaning Recommendation For cleaning and purging of the machine it is appropriate to use polypropylene or polyethylene. Machine must be PVC-free.
The expected shelf life of the TPE granules is a minimum of 24 months from the date of delivery, provided that the storage instructions are followed and the product is kept in the unopened original KRAIBURG TPE packaging. Dry conditions at room temperature (below 40 °C/ 104 °F), away from heat sources and direct sunlight, must be maintained for proper storage. Contact with nitrogen oxides during storage should be avoided.