A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
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Medical Elastomers And Latex


Guidelines for Selection of Thermoplastic Elastomers for Medical Products

Mr. Manan Shah, Rubber Technologist

It is important to select several TPE materials that meet the engineering requirements as well as Medical requirements of the product.

TPE materials should be selected considering the severity of the medical application, which can range from single-use medical disposables to long-term implantable products such as artificial organs.

For long-term implant applications, it is highly desirable that long-term implant data exist on the TPE materials.

The TPE selected for demanding applications usually must undergo extensive animal and clinical testing prior to approval by the Food and Drug Administration for product release to the medical marketplace.

Important engineering requirements for TPE selection:

1. Percent Recovery
2. Hardness
3. Percent extension
4. Flex-life
5. Temperature Range
6. Creep
7. Solvent resistance
8. Cost
9. Processibility Characteristics

Major categories of TPEs have both strong and weak points that must be considered for TPE selection process.

Important Medical Requirements for TPE selection:

The following factors must be considered from both the sterilization as well as the end-use property requirements of the product:

1 Solvent Resistance 10 Drug compatibility
2 Radiation resistance during sterilization 11 Tissue compatibility
3 Steam autoclavability 12 Blood compatibility
4 Elutables 13 Permeability
5 Interference with diagnostic tests 14 Creep
6 Interference with blood tests 15 Abrasion Resistance
7 Aging and embrittlement 16 Biodegradation/hydrolytic stability
8 Long-term implant results 17 Lipid and protein absorption
9 Flex-life in cyclic loading    

Features of TPEs suitability for Medical Disposables:

  1. Excellent recovery from steam autoclaving of TPEs

  2. Cleanliness of TPEs

  3. Ease of Processing

  4. Overall cost economics

  5. Non toxicity.

  6. Elimination of washing steps

Special Requirements in TPEs for Life-support and Implantable Products:

  1. Blood compatibility

  2. Tissue compatibility

  3. Compliance

  4. Protein deposition

  5. Hemolysis

  6. Long-term implant properties

  7. Hydrolytic stability.

Mr Manan Shah, 30, Rubber Technologist ( B.E.), has about 10 Years’ of experience in manufacturing, developing, testing and educating challenging Industrial Rubber Products. He has significantly contributed by providing custom solutions to clients as well as detailed understanding of various processing techniques and formulation requirements.

He also holds a PG Diploma in Import – Export Management and International Finance. Mr Manan Shah is a Lecturer in Rubber technology at L.D.College of Engineering, Ahmedabad, India.

Mr Shah will share his vast experience with readers through a regular column covering essential aspects regarding medical elastomers and latex materials and products.
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