Lubrizol enables Make in India Through High-Quality Components and Raw Material

The Lubrizol Corporation, a Berkshire Hathaway company, provides unmatched chemistry that unlocks immense possibilities at the molecular level. Their solutions are found in products used by people everyday, driving sustainable and measurable results to help the world Move Cleaner, Create Smarter and Live Better.

A key focus segment globally is Medical Device Solutions. They started as a raw material supplier now evolved to a contract design and manufacturing organization over the last decade. For the India region, the medical solutions segment focuses on three aspects: medical grade thermoplastic polyurethanes (TPU) where Lubrizol is an industry leader, followed by precision extrusion for TPU components at the India extrusion facility & the contract design and manufacturing unit which delivers components & finished devices per customer requirements.

Medical Grade Thermoplastic Polyurethane (TPU):

Lubrizol’s approach to polymer synthesis & custom manufacturing sets them apart from any other player in the market. With a strong change control & notification policy, quality audit policy, and biocompatibility evaluation, Lubrizol has been able to lead the market for several decades with a safe product offering. Brand names like Carbothane™, Tecothane™, Tecoflex™, Pellethane®, Isoplast® are benchmarks in the industry and used across various medical applications. The key properties include strength, flexibility, chemical & abrasion resistance, kink recovery and sterilizability. The polymers are available in clear, opaque, radio-opaque, colored options and suitable for in-body applications.

Some of the application areas where our products are used include vascular, cardio, urinary, dental, wound care, and infusion therapies. Besides manufacturing at ISO 9001 facilities, here are a few factors that makes Lubrizol a leader in several markets -

• Strict change control & notification policy
• Stringent Quality audit policy
• Medical device regulatory assistance is available for medical grades and involving any regulatory support that customers need
• Biocompatibility data is a key consideration when choosing these polymers

India Extrusion for TPU Tubing Components

While deciding to embark on the “Make In India” initiative, Lubrizol conducted thorough market research on needs to address in the device development area. The Lubrizol Corporation found - Brand owner's desire better access to the latest raw materials, highquality components, design development support, support with free sampling, reduced lot size, quick turnaround time and ease of doing business like transaction in rupees vs foreign currency, local stocks & lower working capital.

This formed the foundation on which the company set up a local medical tubing facility in India in 2018 and a dedicated ISO 13485 TPU extrusion facility for medical devices was set up in India.

Lubrizol brought their global expertise to India to meet the growing need of precision extrusion for Indian OEMs. The extrusion facility is a state-of-the-art facility as per our global standards for cleanliness and best manufacturing practices.

The facility extrudes custom tubing based on the customer’s selection of raw materials and dimensions. The facility has been operating for over 4 years now. The facility has supplied over 150 different specifications to customers in India and abroad, with the capability to manufacture different sizes and configurations for various end-use applications like IV sets, IV Cannula, Hemodialysis and CVC Catheters, J stents, PICC, Gastric and Nasal Feeding Tubes, Extension Tubes, Pressure Monitoring, ET Tubes and many more.

Contract Manufacturing for Thermoplastic Elastomers and Silicones

Lubrizol also has a wide portfolio to support OEM through their contract design and manufacturing business across seven facilities over three continents. With capabilities like Device Design, Precision Extrusion, Molding, Dip Casting, Sheeting, and Assembly, secondary Ops for TPU and Silicone being the focus.

With Serving >750 customers in 40+ countries and supplying 4,000+ different SKUs to more than 25 of the top 30 Medical OEMs, the Contract manufacturing capability provides more than 85,000,000 medical device components/assemblies/devices per year.

The Device Design is focused on Interventional Vascular therapies, and other similar minimally invasive technologies. Electrostimulation, long term implants, aesthetic, bariatric, neurology surgery, ophthalmology applications are areas where the components are extensively used.

With these three capabilities, Lubrizol is looking at continuing to participate in the “Make In India” initiative and support the medical device OEM with best in class products from raw material, components to finished devices. Contact our regional team for further details and sample enquiries –
Rajnish.Singh@Lubrizol.com

Lubrizol is focused on the healthcare market and not only participates in the medical devices segment with the polymers, design and manufacturing capabilities but has a strong presence in the pharmaceutical, nutraceuticals market & oral care markets through their extensive product offering which enable differentiated end formulations for customers globally with an aim at improving patient outcomes!.