Performance Polymers

Safety for Patients, Reliability for Processors

BASF offers an extensive portfolio of engineering plastics for medical technology needs and fulfills the increasing customer demands for medical applications by offering high-performance profiles and long-term formulation consistency.

High-Performance Engineering Plastics for Maximum Patient Safety

Ultraform^® PRO (POM) and Ultradur^® PRO (PBT) are high-performance engineering plastics designed to deliver exceptional formulation consistency and reliability for the strict requirements of the healthcare and medical device industry. The designation PRO (Profile Covered Raw Materials Only) ensures that only carefully controlled raw materials are used throughout the enhanced manufacturing process. Combined with rigorous testing procedures, this guarantees consistent material quality and enhanced product safety. In addition, the comprehensive PRO service package supports reliable change control and helps ensure compliance with pharmaceutical and medical regulatory standards.This enables manufacturers to achieve efficient, safe, and worry-free production of medical devices.

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Focus Topic: Drug Delivery

Main Applications

Insulin Pen/ Auto Injector
Inhaler

Materials

✓ Ultraform^®PRO (POM) and/or Ultraform^® PRO TR (POM, Tribo)

✓ Ultradur^®PRO (PBT) and/or Ultradur^® PRO TR (PBT, Tribo)

With its medical PRO grade portfolio, BASF Engineering Plastics delivers reliable, high-performance and sustainable solutions for medical applications. In this session, discover how our Verbund system ensures secure supply and efficient production, and how our PRO Service Package enables compliant, worry-free manufacturing.

PRO Service Package - Safety for Patients, Reliability for Processors

Commitment

High quality and product purity
Consistent formulation acc. to Drug Master File (DMF)
Long-term supply assurance
Advanced change notification process (36 months)
Change management procedures

Handling

Production conditions according to GMP principles*
Dedicated production line concept and enhanced quality control procedures for raw material and final product
Back up production line concept (security of supply)
Sample retention and documentation
Effective risk management procedures

*Commission regulation (EC) No 2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food

Regulation

Support of global regulatory approvals for pharmaceutical and medical applications
Material compliance to FDA and EU requirements
Certified Biocompatibility (USP Class VI / ISO 10993)
Drug Master File (DMF) Listing
Latex free, ROHS, Phthalate free (REACH compliant)

Support

Increased technical support (color trend, design assistance, analytical testing, calculation (FEM), simulation / filling studies (mold flow), individual part testing, processing guidance, troubleshooting etc.)
Extensive research and development capabilities
Testing the compatibility of the plastic to specific chemicals
Plant audits
Access to over 50 years of application innovation in different industry areas

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More Information

All information in one place: From technical articles, case studies and brochures, to data sheets and certificates.

Information & Certificates

Explore Our Medical Applications Range With Our Interactive PDF!

Preview PDF (26.23 MB)

Our Medical Application Range

Our Product Range for Medical Applications

We offer a comprehensive range of products with a broad variety of property profiles. Find the right product for you!

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Self-service solutions: Downloads Finders

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FAQ

Q: Does BASF produce plastics for medical technology needs?
Yes, BASF offers an extensive portfolio of engineering plastics for medical needs
with the highest formulation consistency.

Q: Which plastic materials ensure medical safety?
Ultraform^® PRO and Ultradur^® PRO use controlled, raw materials to ensure safety.

Q: Are engineering plastics safe to use in medical applications?
Yes, engineering plastics are safe to use in medical applications. With the PRO
Service Package, quality and support are ensured while EU requirements are met.

Q: Which products are included in the product range for medical applications?
BASF’s product range for medical applications includes Elastollan^® for sensitive
applications, Ultraform^® PRO (POM) and Ultradur^® (PBT) for medical applications, and
Ultrason^® for temperature resistance.