Mediprene® 502584M

Category: TPE , Thermoplastic Elastomer
Manufacturer: ELASTO
Trademark: Mediprene®
Fillers: -
Ports: Qinzhou, Shekou, Shanghai, Ningbo
Delivery Terms FOB, CIF, DAP, DAT, DDP
PDF: gGMM0N_Mediprene-502584M.pdf
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ELASTO 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.

Regulatory compliance
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.

The raw materials in these compounds comply with food contact norms like FDA 21CFR and 2011/10 EC. All polymers used have passed tests according to USP class VI and the paraffinic oil has passed the USP Mineral Oil NSF H1, reg 125038 and also the European Pharmacopeia, liquid paraffin.

Mediprene TPEs are latex free, which reduces the risk of allergic reactions. Representative grades have passed cytotoxicity tests according to ISO 10993-5 and biocompatibility tests according to USP Class VI.
General Information
Features
  • Biocompatible
  • Food Contact Acceptable
Uses
  • Medical/Healthcare Applications
Agency Ratings
  • EU 2011/10/EC
  • FDA Unspecified Rating
  • ISO 10993 Part 5
  • USP Class VI
Appearance
  • Black
  • Colors Available
Processing Method
  • Extrusion
  • Injection Molding
PhysicalNominal ValueUnitTest Method
Specific Gravity 0.880g/cm³ASTM D792
Melt Mass-Flow Rate (MFR) (190°C/2.16 kg)3.0g/10 minASTM D1238
HardnessNominal ValueUnitTest Method
Durometer Hardness (Shore A, 4.00 mm)58ASTM D2240
MechanicalNominal ValueUnitTest Method
Tensile Strength ASTM D638
    -- 10.5MPa
    100% Strain 1.60MPa
    300% Strain 2.50MPa
Tensile Elongation (Break)800%ASTM D638
ElastomersNominal ValueUnitTest Method
Tear Strength 22.5kN/mASTM D624
InjectionNominal ValueUnit
Rear Temperature 180 to 220°C
Middle Temperature 180 to 220°C
Front Temperature 180 to 220°C
Mold Temperature 20.0 to 50.0°C
ExtrusionNominal ValueUnit
Cylinder Zone 1 Temp. 150 to 210°C
Cylinder Zone 2 Temp. 150 to 210°C
Cylinder Zone 3 Temp. 150 to 210°C
Cylinder Zone 4 Temp. 150 to 210°C
Cylinder Zone 5 Temp. 150 to 210°C
Resin Grade Manufacturer Category Trademark
RTP 4005.3 FR A HS RTP Company PPA RTP
Sylvin 5132-75UV Red 6281 Sylvin Technologies Incorporated PVC, Unspecified Sylvin
AZDEL™ C300B04N Azdel, Inc. PP Alloy AZDEL™
Hipolyene 4955 T Zylog Plastalloys TPO (POE) Hipolyene
Sylvin 5150-65 Grey 9499 Sylvin Technologies Incorporated PVC, Unspecified Sylvin