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Medical Polymers

Plastics and elastomers for medical products, devices, and supplies

This data module is an extended version of the PolymerUniverse data module providing additional properties and information that help you to design medical or food contact products, devices, and supplies.

A meniscal knee replacement - the "meniscus" is UHMWPE

The problem

Plastic materials have widespread uses in medical devices and instruments. If you specify materials for such applications, you may face the following challenges:

How do you ensure an audit trail for your material selection in medical product design?
How do you conduct an exhaustive search for the most suitable materials for the design?
How do you make that search reproducible?
How do you navigate the wide choice of commercially available plastic and elastomer grades?
- ~70,000 generic plastic / elastomer grades in total
- ~6,000 food contact grades (FDA, EU, NSF, or BfR)
- ~600 medical grades (USP Class VI or ISO 1093)

The Granta solution

The Medical Polymers data module is now available to answer these questions.

It is an expanded version of Granta's PolymerUniverse data module and it contains all types of polymer material – both medical and non-medical:

Thermoplastics
Thermosets
Elastomers - both rubbers and TPEs
Advanced composites

Key challenges that have been met in developing the Medical Polymers data module have been:

to assemble sterilizability data - materials can be selected based on their durability to ethylene oxide, radiation, or steam autoclave processes
to identify all materials that are available in medical or food contact approved grades
to ensure comprehensive coverage of two very important sub-classes of material used in medical device, transparent plastics and elastomers - both have been elaborated in the latest release

Medical Polymers can be accessed within GRANTA MI or combined with the CES Selector software to create the CES Medical Polymer Selector.

You can read a short case study of the use of the medical plastics data within CES Medical Polymer Selector.

Design requirement	How the Medical Plastics data module helps	Design significance
Materials selection	Covers nearly all types of plastic and thermoplastic elastomer used in medical devices today AND those not currently used.	Rapid evaluation of almost all possible materials options – early in design to avoid requalification costs.
What materials are available in medical grades?	Identifies materials available in ISO 10993 or USP Class VI grades, plus their tradenames.	Enables faster and more certain regulatory approval of a device (FDA 501(k)) or a drug (NDA)
What materials are available in food contact grades?	Identifies materials available in FDA 22 CFR 177, EEC/EU, NSF 51/61 or BfR food contact grades.	Indicates the possibility of passing medical biocompatibility testing.
Sterilizability	Sterilizability rankings for: Ethylene oxide (EtO); Steam autoclave; Radiation: gamma or electron-beam. References and notes on the effect of degradation due to sterilization.	This is an essential constraint for most medical devices. Disposables must withstand one or two cycles; other equipment repeated sterilization.
Transparent materials	Broad coverage of transparent and translucent plastics.	The healthcare industry attaches a premium to product transparency. It is essential for drug delivery devices, medical packaging, tubing, and fluid containers.
Durability to chemicals and UV light	Chemical resistance ratings of materials to 190 chemicals; Environmental stress cracking (ESC) resistance index for thermoplastics; UV resistance ratings.	Reduce recalls, redesign, re-approval. Avoid going down a material route where ESC (a common failure mode in plastic components) or degradation due to fluid environments or sunlight become problems.
Low temperatures	Impact strength @ -30C; Minimum service temperature.	Some medical devices are stored at deep freeze, dry ice, or even liquid nitrogen temperature. Screen out materials that embrittle at low storage temperatures.
Barrier properties or permeability	Permeability to: Oxygen, water vapor, carbon dioxide (CO2), nitrogen (N2)	Protect efficacy of packaged drugs and medical supplies in blister packs, bottles, containers, bags, etc.
Environmental impact	Estimates for embodied and processing energy, CO2 footprint, recycling.	Company environmental policies. Assist compliance with environmental regulation.
Mechanical, thermal, and electrical	The full range of mechanical, thermal, and electrical design properties.	Nearly all products have mechanical, thermal, or electrical design constraints.
Cost	Relative cost of raw materials and forming processes.	Cost reduction is an objective of nearly all product design. Cost avoidance early in product design is the most effective means to drive out cost.