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    Performance Polymers Ultraform® PRO/Ultradur® PRO for Medical Applications

    Ultraform® PRO and Ultradur® PRO for Medical Applications

      We offer engineering plastics that have been optimized not only for medical applications (PRO = Profile covered Raw materials Only) but also with a comprehensive service package that guarantees formulation consistency and safety – from the raw material through to the patient.

       

      Ultraform® PRO – Polyoxymethylene Plastics (POM)

    Properties

      • For high mechanical and tribological strength
      • High crystallinity
      • Ideal combination of strength, stiffness and hardness
      • Low friction and good abrasion resistance
      • Low material fatigue under mechanical load
      • Excellent chemical and hydrolysis resistance
      • Suitable for sterilization with superheated steam, plasma and ethylene oxide
      • Good resilience
      • Good processability

    Potential Applications

      • Functional and mechanical components for medical devices such as insulin pens, inhalers and atomizing devices
      • Components such as spring and snap-elements, gearwheels, valves
      • Sliding friction systems such as cylinders, screws, slide regulators
      • Clamps, hooks, closure elements
      • Handles for surgical applications

      Ultradur® PRO – Polybutylene Terephthalate Plastics (PBT)

    Properties

      • High accuracy of detail and dimensional stability
      • Wide chemical resistance
      • Low water absorption
      • Ideal sliding friction
      • Outstanding heat ageing behavior
      • Suitable for sterilization with ionizing radiation and Ethylene oxide
      • Good printability
      • Good processability with rapid cycle times

    Potential Applications

      • Functional and mechanical components for medical devices such as insulin pens, inhalers and atomizing devices
      • Components such as nozzles, screws, valves, caps, pistons
      • Supports and casings
      • Filter systems
      • Containers
      • Closures

      The PRO Service Package Contains

      Approvals

    Pharmaceutical and Medical Applications

      • EU Pharmacopeia (EP 8th Edition, Chapter 3.2.2
        “Plastic Containers and Closures for Pharmaceutical Use”) basic requirements
      • Japanese Pharmacopeia (16th Edition, General Information, “G7 Plastic Containers for Pharmaceutical Products”) basic requirements
      • US Pharmacopeia ( USP Biological Reactivity Test Class VI )
      • Biocompatibility (Cytotoxicity according to ISO 10993-5)
      • Drug Master File (DMF )

    Food Contact Applications

      • Commission Regulation (EU) No. 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food as amended
      • Commission Regulation (EU) No. 2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food
      • 21 CFR Food Additive Regulations (FDA Compliance)
      • FDA Regulation 21 CFR § 177.2470 “Polyoxymethylene copolymer”
      • FDA Regulation 21 CFR § 177.1660 “Poly (tetramethylene terephthalate)”

    Other Applications

      • Heavy Metals (CONEG (Coalition of North Eastern Governors) for the January 1, 1994, EU Directive 94/62/EEC on heavy metals, EU Directive 2000/53/EC on end-of life vehicles as amended
      • BSE / TSE Transmittance (no risk materials are used in the production, monomers / ingredients are of petro-chemical origin, additives from animal origin are in accordance with note for guidance EMEA /410 /01 Rev. 03 adopted by the CPMP (Committee for Proprietary Medicinal Products) and CVMP (Committee for Veterinary Medicinal Products). In addition the treatment exceeds the requirements of the directive 2000 /6 / EG Annex II

      Disclaimer

      BASF has not designed or tested its plastics with respect to all of the special requirements related to their use in medical devices and pharmaceutical applications. Therefore, BASF makes no warranties concerning the suitability of any BASF plastics for use in any medical device and pharmaceutical applications. Subject to an evaluation and a release in each individual case and, if necessary, acceptance of a disclaimer by the customer, BASF is in general prepared to supply plastics for medical applications. However, BASF does not supply its plastics for the manufacture of implants in any risk class. In all cases the BASF customer has to establish from their own experience and from tests on BASF plastics, that these plastics are suitable for the manufacture of products for medical applications or pharmaceutical applications and the customers have to ensure that the medical device or pharmaceutical application manufactured using BASF plastics is safe, lawful and technically suitable for the intended use.

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