Cover Story

Medical Polymers In India: Technological Developments And Growth Pattern

Bio - Compatible, Light Weight, Low - Cost, Compatible With Human Organsib

 

.. Mr. R. C. Gupta Sr. General Manager K L J Polymers & Chemicals Ltd. - Unit-II

Mr. R. C. Gupta has completed his M.Sc. (Hons.) school from Punjab University & AMIIE Chem., Calcutta. He worked with Shriram Polytech at Kota (A division of DCM Shriram Consolidated Limited) for over 34 years. Presently since the last 12 years,  he is working with KLJ Polymers & Chemicals Ltd., (KLJ Group) at Silvassa. He has more than 46 years of experience in PVC Compounding Industry. At KLJ in addition to PVC, they have other Polymer Compounding like TPR, TPE, PP, EVA, XLPE etc..

The growth of consumption for medical polymers in India.

Polymers commonly known as Plastics offer a wide variety of materials ranging from soft to hard and tough as well as biostable and biodegradable materials. Plastics are an ideal class of materials which cover large application areas in health and healthcare due to their lightweight, bio-compatibility, non-corrosive nature, chemical inertness, low cost and comparable densities with that of human organs. In some cases, they may contain additives or reinforcing agents to modify and/or enhance properties. Plastics used in medical applications must adhere to very rigid National and International Standards, and must be non toxic, non-carcinogenic, biocompatible and in no way injurious to the biological environment.

Globally polymers consumption in healthcare sector is around 1% of total polymers consumption. Indian healthcare sector is estimated to be around US$ 60- 65 billion. In the next 15 years, it is expected to grow by 15% CAGR.

India has already emerged as preferred Medical Tourism Destination. The modern healthcare demands for more polymer based products right from Syringes to Implants.

Main applications of polymers in healthcare:

.PVC: Blood bags, IV Set Tubing, Surgical Gloves, Suction Pipe, Nose Mask, Drip Chambers, Blister Packaging, Syringe Gasket, Catheters, Urine Bags, And others.

LDPE: Packaging Film, Wound Covering Films, Urine Bags,

LLDPE: Catheter Tracheal Prostheses

HDPE/MDPE: Blood Filters, Reconstruction Ff Joints, Splints, Fluid Bottles, Syringes.

UHMWPE: Joint Replacements Rostheses

PP: Membrane Support Suture, Packaging Foils, Syringes.

Polyamides: Surgical Instruments, Suture Material, Artificial Skin.

TPE: Gaskets For Syringes

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

To serve healthcare industry, we at KLJ has two divisions i.e., KLJ Plasticizers & KLJ Polymer & Chemicals Ltd., Unit-II.

KLJ Plasticizers has three specific plasticizers for PVC compounds for medical applications, plasticizers are added to rigid PVC to turn it from being hard and brittle to soft and flexible.

• Di Octyl Phthalate (DOP) Supper, DOP is the most common plasticizer used in PVC for medical applications since long. KLJ DOP Supper is specially cleaned/ modified to be suitable for medical applications.

• Phthalate free K-8080 since the last few years, in some countries, DOP is restricted & they want phthalate free plasticizers to be used in PVC for medical grade applications. KLJ has developed & is regularly supplying K-8080 for this application.

• DINCH To replace phthalate plasticizer, BASF has developed Hexamol DINCH a safe plasticizer for intensive human contact.

KLJ is strategic partner of BASF for DINCH in India.

KLJ Polymers & Chemicals manufacture many PVC compound grades for medical applications based on DOP Supper, K-8080 & DINCH.

KLJ compounds are used to manufacture:

Blood Bags Gloves  IV SETS Tubings Cannula

Syringe Gaskets Dialysis Catheters

Nose Mask Drip Chambers External Feeding

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

1. KLJ PVC compounds are manufactured under ISO 9001 & ISO-14001 certified facilities.

2. KLJ ensures that all additives used in compounds conform to BIS 10151, suitable for use in food and other human contact applications.

3. KLJ compounds adhere to various national & international standards. IS- 10151, ISO-3826, ISO-10993

4. KLJ compounds pass in Cell Structure Cytotoxicity, Hemolysis, Acute Systemic Toxicity, Skin Sensitization, Intracuteneous Irritation tests and others.

5. Hexamol DINCH complies with a wide range of regulatory requirements, like:

• Food Contact

  •  Listed in Commission Regulation(EU) No. 10/2011

  • German BIR-Plastic recommendation for food contact

  • Switzerland(list II, Annexure1 of Verordnung des EDI

  • Uber Bedar fsgegenstande* (SR817.023.021)

  • Japan Hygenic PVC Association (JHPA)

  • Chinese Standard GB 9685-2008

  • Australia NICNAS

  • Korea

• TOYS - EN 71-3, EN 71-5, EN 71-9

• MEDICAL DEVICES

  • CEN EN ISO 10993-17(2002) Safety Evaluation

  • Directive 2007/47/EC

KLJ has well equipped R & D centre to develop tailor made compounds for Health care applications.

It is necessary for all of us to educate public, authorities, hospitals & other medical staff to use good quality/ approved materials only in health care.

We at KLJ ensure to give only approved quality raw materials for end product moldings/applications. We have very stringent quality testing/ norms for approval of product before dispatch. Now, it becomes the responsibility of the end user to select the appropriate raw material, process it properly in neat & clean atmosphere and ensures that it performs well in the finished device.

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