Medical & Pharmaceutical

RESINEX is a trustful partner for the medical and pharmaceutical industry, as a broad portfolio of unique polymers is available to meet the requirements of this strongly regulated market. For this reason special trusted brands are available, with the commitment to a long-term partnership and to serve the medical and pharmaceutical industry in the best possible way.

RESINEX is a preferred partner of polymer converters, producers and brand owners due to the fact that RESINEX is able to supply polymers throughout Europe as RESINEX sales offices are located in all European countries.

To meet the requirements of this growing market, a marketing and technical service team is especially dedicated to this segment, to be able to have a better understanding of the needs of this special industry and to give better service to our customers. This includes close cooperation during every step of product development, from material selection, suggestions for tool design, MoldFlow analysis, provide information about chemical resistance, advice for sterilisation suitability, production guidelines and by providing the required certificates for the several approval processes required for medical and pharmaceutical applications.

Examples of typical applications:

  • Medical device and drug delivery systems
  • Drug packaging and closures
  • Pumps and inhalers
  • Infusion components
  • Components for haemodialysis
  • Housing and covers for medical device
  • Catheters and wound care
  • Disposables

Additionally to medical and pharmaceutical applications, these polymers step in applications like diagnostics, laboratory and health care as for such applications, the advantages of the polymers especially developed for sensitive application, bring advantages to the finished product. Such advantages are: clean parts, long term availability, easy processing and benefits from available biocompatibility or food contact certifications as well as durability of the products.

Key features of polymers for medical and pharmaceutical:

  • Clean materials*
  • Easy processing*
  • Long term availability*
  • Available certifications*: Food approval (FDA, EU 10/2011), Drug Master File (DMF), European Pharmacopoeia (EU EP) biocompatibility US Class VI, or biocompatibility ISO 10993
  • Productions according to GMP* and/or clean room*

* Certificates are available on request only, not all certificates are available for all products. Please contact your local RESINEX dealer to receive more information.

Risk evaluation

The primary intention of RESINEX is to present a safe and reliable service to our customers and stakeholders. The intention is to keep the risk low for all involved parties, like the polymer producer, distribution, part manufacturer, OEM or brand owner and overall the end user or patient. Before selecting a material for your application, please contact your local RESINEX sales office to receive more information. RESINEX does not sell any polymers for implants.

The following polymers are available for production of Medical & Health Care applications (the product availability may differ in each country based on local Resinex distribution rights):

Properties summary for selected polymers:

ALTUGLAS® Medical Resins Polymethlymethacrylate (PMMA)

Altuglas International has produced polymers with outstanding properties and durability for 30 years. Especially developed for disposables, the resins dispose of excellent properties like brilliant optical properties, chemical resistance and are sterilisable. Furthermore these resins are easy to process and due to the outstanding melting properties the product is available for a wide range of applications and processing methods.

Available grades:

  • ALTUGLAS® CR50 — Increased chemical- and lipid resistance
  • ALTUGLAS® CR30 — Increased chemical resistance
  • ALTUGLAS® SG 7 — High flow
  • ALTUGLAS® SG 10 — Good flow, good impact resistance
  • ALTUGLAS® VS UVT — High UV transmission

Arkema special performance polymers Pebax®, Rilsan®, and Rilsan® Clear.

PEBAX® is a thermoplastic elastomer (TPE-A) made up of block copolymers consisting of a sequence of polyamide and polyether segments. The advantage of the material is the low density, a wide range of flexibility, excellent mechanical properties as well as good chemical resistance. The PEBAX® SA series is especially developed for use in medical applications like catheters, connectors, tubes, medical devices and disposables. PEBAX® SA complies with the biocompatibility test according to USP Class VI. It is possible to use PEBAX® alone or as a blend to improve the properties of other polymers. PEBAX® SA can be sterilised with the main used sterilisation methods.

Arkema offers Polyamide 11 and Polyamide 12 based product suitable for certain medical applications.

Special grades from Rilsan® PA 11 which are compliant with several biocompatibility tests are suitable for medical device components.

Rilsan® Clear is a polyamide based performance polymer, tested according to USP Class VI. Rilsan® Clear is a rigid and transparent polyamide with good chemical resistance. It can be used for medical devices or disposables, where a high clarity and temperature resistance are required.

Rilsan®, Rilsan® Clear and Pebax® can be used perfectly for 2K parts, as all products are polyamide based making intrinsic bonding of 2K applications possible.

Chevron Phillips K-Resin® Styrene-butadiene copolymer (SBC)

K-Resin® SBC is a styrene-butadiene copolymer (SBC) which can be used alone or blended with other polymers like polystyrene. K-Resin®SBC obtains improved shatter resistance combined with a sparkling clear appearance. The use of K-Resin® SCB is more economic, compared to other more expensive polymers. A further advantage of K-Resin®SBC is the low density.

It is possible to blend K-Resin® SBC with other polymers like HIPS, ABS, SAN or SMMA, to improve impact resistance and gloss. K-Resin® SBC can easily be processed in injection moulding, extrusion, blow moulding or thermoforming by using standard processing equipment.

In the medical industry, where economic aspects shatter resistance and safety is crucial, K-Resin® SBC is an especially interesting solution. Other applications require a good transparency to control the dosage and filling level of drugs or solutions and at the same time high breakage resistance. Drug packages made of K-Resin® SBC are break resistant, sparkling clear, easy to produce, economic and easy to recycle.

K-Resin® SBC has been tested for biological performance and meets the U.S. Pharmacopoeia (USP) XXIII Class VI requirements, is compatible with blood, demonstrates no cytotoxic, mutagenic or irritant potential, is not a sensitised, and is sterilisable by gamma irradiation, ethylene oxide gas or electron beam irradiation.

DOW (Health+™) Low-Density Polyethylene (LDPE)

DOW offers two LD-PE grades, which have been designed first of all for BFS (Blow-fill-seal) bottles, but can also be used in injection moulding and blow moulding applications

  • DOW™ LDPE 91003 (MFI 0.3; density 926) — suitable for heat sterilisation up to 110°C.
  • DOW™ LDPE 91020 (MFI 2.0; density 923) — more easy flowing and also suitable for injection moulding applications.

These products are available at RESINEX as HEALTH+™.

ExxonMobil™ Polypropylene (PP)

ExxonMobil™ is an experienced producer of polypropylene suitable for injection moulded parts for use in medical devices and drug packaging.

This includes the homopolymer grades, ExxonMobil™ PP1013H1 and PP1014H1, which are specifically designed for the pharmaceutical market and are typically used for medical goods such as syringes, inhalators and pumps, packaging applications such as boxes, closures and dispensers. Additional application focus areas include the laboratory sector and diagnostics. In accordance with industry specific high hygiene requirements, these grades can be sterilised using steam or ethylene oxide.

ExxonMobil™ PP9074MED polypropylene is a random copolymer that exhibits good flow properties and high clarity, making it suitable for diagnostic applications, syringes and similar medical products. This grade is also designed to withstand high energy radiation, such as gamma rays, often used to sterilise moulded parts.

All grades are optimised for injection moulding.

Styron CALIBRE™ Polycarbonate (PC)

Styron produces special clean CALIBRE™ polycarbonate at the Stade (D) production unit. In the past years the quality in terms of transparency, yellowness and constant viscosity has been improved by consistent optimisation of the production. The production occurs in clean room conditions and following GMP.

The following series are available:

  • CALIBRE™ 2060-SERIES — suitable for steam and ethylene oxide sterilisation
  • CALIBRE™ MEGARAD™ 2080-SERIE — suitable for gamma or electron beam sterilisation
  • CALIBRE™ 5000-SERIES — glass fibre filled, fire resistant, ISO 10993

Additionally CALIBRE™ MEGARAD™ Polycarbonate grades with increased lipid resistance are available.

Disclaimer

The above mentioned information is compiled according to our best knowledge and the knowledge available at the time of publication. Irrespective of this RESINEX does not guarantee the completeness or accuracy of the information and assumes no responsibility regarding use and possible error. The information contained does not constitute any specification, parameters or guarantee of the properties of the products. This document is not a guarantee for the suitability of a particular purpose and fulfilment of specific requirements. It is the responsibility of the processor to consider the product’s suitability for the specific purpose.