Cover Story

Medical Polymers In India: Technological Developments And Growth Pattern

Safer, High Quality Alternative

The specific product areas where polymers being supplied by the company have substituted conventional materials for medical applications.

Thermoplastic Polyurethane: A Safer, High-Quality Alternative to Polyvinyl Chloride for Medical Device and Wound Care Product Manufacturing.

• For decades, polyvinyl chloride (PVC) has been a commonly embraced material for use in medical device manufacturing due to its affordability and the functionality it provides once softened. Progressively, however, PVC has been abandoned around the world as a compelling medical device material for a number of reasons, primarily due to concerns about chemicals exuded from PVC-based medical devices during regular use and disposal.

• Reproductive system development issues, liver damage, cancer and disposal are just some of the catalysts for change that make TPU a strong substitute for PVC in a market place increasingly averse to PVC-based medical products.

Medical-Grade TPU as an alternative to Silicone: Lubrizol Life Sciences medicalgrade thermoplastic polyurethanes (TPUs) are ideal for many medical applications. Lubrizol TPUs are an alternative to silicone in very selective applications. Key benefits of TPU technology that improve patient comfort include :

• Superior strength

• Clog resistance

• Excellent flow rate

• Cost-competitive

• Abrasion and cut resistance

• Grades as soft as 62A that feel like silicone

• Longstanding history in medical applications

• Material softens in the body resulting in increased patient comfort.

• Patient comfort is increased due to the combination of Lubrizol’s TPUs’ superior strength, durability and softening characteristic, which allows for equal flow rates at a smaller catheter profile.

Effect of Improving Regulations on the global medical device industry. The regulations and compliance criteria met by Polymers Supplied by The Company.

Our pharmaceutical grade polymers are manufactured according to cGMP standards in ISO 9001 certified facilities. Lubrizol works with all relevant regulatory bodies including USP/NF, Ph. Eur. and JPEto maintain global pharmacopeia status. Medical device sector polymers are produced in ISO 9001 certified facilities. These medical grade polymers are evaluated for biocompatibility and biostability using a variety of globally recognized standards which include USP Class VI and ISO 10993.

• Assistance with regulatory and product compliance requirements.
  - Lubrizol will assist your efforts to pursue new business opportunities and support your existing business by providing information required by compliance authorities.
  - Lubrizol will also provide information on polymers necessary to support drug and device filings with the US FDA and other national/regional regulatory bodies.

• Medical-grade products manufactured in ISO 9001:2008"certified facilities.

• Plant audits available upon approval and audit packet availability.

• Opportunities to assess and address risk identified.

• Strict adherence to policies and procedures.

New developments in the polymers supplied by the company.

Some of the new developments from the past 2-3 years include:

• Vesta– Lubrizol Corporation has announced the acquisition of Vesta, a leading contract manufacturer for the global medical device industry.

• The acquisition broadens Lubrizol’s life science manufacturing capabilities, applications, and material portfolio with access to silicone and a variety of other thermoplastics utilized in medical devices.

• Tecothane™ Soft TPU– This new technology features good mechanical properties, excellent resilience and recoverability, while also providing a range of material hardnesses. The new Tecothane Soft TPU products also feature low specific gravity and better alcohol and chemical resistance compared with standard polyurethanes.

• Aromatic Carbothane™ TPU- Greater material strength, improved chemical resistance and increased resistance to creep make these TPUs a strong option for both long-term implants and permanent implants used in spinal and orthopedic applications.

• Flame Retardant Technology– The first medical grade TPU to provide excellent flame-retardancy, low smoke and low toxicity, this technology is ideal for electrical devices used in operating rooms or for patient care.

• Pathway™ Excipients– Pathway™ TPU is a versatile polymer that can be tailored to suit a wide range of applications and be processed in many ways. For drug delivery, it can be hot-melt extruded or solvent cast into shapes such as rods, tubes, films and a variety of matrix - type designs. Multiple methods can be used to sterilize TPU, including ethylene oxide, hydrogen peroxide, E-beam radiation and gamma radiation.

• Advanced Wound Care– Our wound care applications exhibit biocompatibility, absorbency, barrier and balanced moisture vapor transmission rate (MVTR) properties, which ensure the necessary amount of protection from contaminants and microbes for healing tissues while also maintaining one-way transmission of moisture for breathability. Our TPU products can be tailored for a variety of wound care applications. For instance, Tecophilic™ and Pellethane® TPUs are used in films, tapes and backings. Tecophilic TPU and Carbopol® polymers are ideal for hydrogel applications.

• Multilayer Constructions– Such is the case for medical products based on polymer technology-both in high-density polymeric applications, like medical devices, or lower-density applications, such as wound care films and dissolvable sutures.

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