Produkty

Ultraform^® 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

Further Information

The PRO Service Package Contains

The intention not to change the formulation¹ in the long term (with the exception of alterations required in the event of legal or regulatory changes)	►Allows long-term planning for the customer
The promise to give customers at least 3 years notice, if there have to be changes to the formulation*	►Allows long-term planning for the customer
BASF suppliers are obliged to guarantee the purity of the substances supplied to BASF	►Reduces testing efforts
Worldwide support with approvals for medical and pharmaceutical applications and for food contact	►Simplifies and shortens registration procedure for the client
Testing of compatibility of plastic with specific chemicals	►Reduces testing efforts ►Simplifies decisions
Technical support for applications (processing, design, calculation)	►Reduces and simplifies the development phase
¹ Formulation as defined in the Drug Master File (DMF)

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.

Ultraform® PRO for Medical Applications

Ultraform® PRO – Polyoxymethylene Plastics (POM)