TAGS: Medical
KRAIBURG TPE offers high-quality custom-engineered THERMOLAST® M TPE series compounds for medical device applications including for direct contact with blood and body fluid management products.
Drawing the Material Benefits of TPE
The THERMOLAST® M series offers the advantages of resealing, low surface friction and high elasticity; and has a hardness range from 60VLRH (Super Soft) to 50Sh D (Semi Rigid) that are suited for applications for blood collector cap sealing; infusion caps, which are widely used in sealing for pump dosage systems; injection fuel plugs, seal head of syringes, urinary catheter caps, menstrual cups, and hoses.
Evidence of Safety
The THERMOLAST®M compounds are free of animal-based ingredients; and free of latex, PVC, and phthalates. The compounds are produced without the use of heavy metals; and are sterilizable under autoclave 134°C, gamma radiation 2x35 kGy, and EtO-gas.
The TPE series meets the requirements of the VDI 2017 guideline for medical grade plastics (MGPs) issued by the Association of German Engineers (VDI), as well as the Reach and RoHS standards. The compounds are tested according to DIN ISO 10993-5 Cytotoxicity; DIN ISO 10993-4 Haemolysis, indirect blood contact; DIN ISO 10993-10 Intracutaneous irritation; DIN ISO 10993-11 Acute system toxicity; and USP Class VI Extraction.
KRAIBURG TPE strives to maintain the standards of its products by providing a unique service package that focuses on our customer needs in constantly recording manufacturing process in the drug Masterfile (DMF); and by guaranteeing 24-month supply security and purity of our raw materials through the commitment of our suppliers and a dedicated production unit for THERMOLAST® M to ensure the quality, safety and reliability of our TPEs.
Source: KRAIBURG TPE