Alpesh Gandhi, Technical Director, Ami Polymer Pvt Ltd, shares the company’s profile and future plans in a conversation with IPF Magazine.

What are the various silicone products manufactured at Ami Polymer Pvt. Ltd. (APPL)?

The extensive range of products offered includes silicone transparent tubes (peroxide and platinum cured), platinum cured silicone transparent braided hoses, silicone autoclave gaskets, FBD inflatable gaskets for fluid bed dryer, tri clover gaskets (silicone, viton, EPDM), silicone and viton sheets, ‘O’-rings (silicone, viton, EPDM, nitrile and neoprene), silicone solid cords ( round and square type), silicone sponge cords and gaskets, extruded profile (silicone, viton, epdm), fep encapsulated O-rings, butterfly valve gaskets, isolator gaskets, lypholisation door gaskets, viton cords and tubes, silicone vacuum bellows, silicone diaphragms for novaseptic membrane valves and roplan (steriodose make “zero dead-leg” valve (sterivalve), silicone sleeve for corona treater application, validation gaskets and sensor tc “smart” gaskets, silicone antistatic gasket.

What are the applications that can be availed using the products?

Ans: At APPL, we understand that not all industries face the same issues in the areas of regulation, geography, customer base and business climate. We offer industry-specific expertise to help solve our clients’ unique business challenges. With a long history in pharmaceuticals industries, APPL has also defined and delivered custom solutions in other industries including food processing, medical and surgical, healthcare, automobile, OEM’s engineering, aerospace and many more. This industry experience has resulted in a proven delivery process which reduces uncertainty and delivers predictable outcomes for strategic, operational, and technical planning and initiative implementations.

Silicone rubber is a synthetic product. What advantages it has over natural rubber?

Silicone is most flexible among all the available types of rubber. Silicone Rubber has excellent Thermal resistance properties. It has a wide service temp range from -80 °C to + 250° C. Silicone Rubber has excellent weather resistance properties like oxidation resistance, ozone resistance, and UV light resistance. Silicone rubber has low coefficient of friction which is helpful to prevent adherence of fluid particle on its surface. Silicone is odorless, tasteless and most compatible polymer with body tissues. It is suitable for food, pharma, biopharma and medical applications.

How silicone is contributing in engineering industries and applications?

Silicone retains excellent flexibility in low temperature, which is helpful in freeze dry processing machines. Due to excellent compression set properties at high temperature, silicone profiles are widely used in sealing the gap in engineering application. Due to high dielectric strength, silicone is useful in electrical industries related applications like cover for corona treatment machine. Silicone is a versatile polymer which is useful in solar industry, home appliances, paints and coatings, personal care products, adhesive and textile industries.

Could you provides details on the tube and hose products alongwith their USP?

We have six registered brands in Tubings: Imapure - platinum cured silicone tubing for critical fluid transfer application (regulatory market), Imatech - platinum cured silicone tubing for critical fluid transfer (domestic and ROW market), Imaprene - thermoplastic elastomer tubing for peristaltic pump application/IPA transfer, Imaweld - heat sealable and weldable thermoplastic elastomer tubing for biotech applications, Imachemton - fluoro elastomer tubing for corrosive chemical transfer application and Imapex - peroxide cured silicone tubing for noncritical fluid transfer applications.

Five registered brands in hoses: Imafit - platinum cured silicone hose with polyester braiding reinforcement, Imavac - platinum cured silicone hose with SS 316L wire reinforcement for vacuum applications, Imavacfit - platinum cured silicone hose reinforced with SS 316 L wire and polyester braiding, Imawrap - platinum cured silicone hose reinforced with SS 316L wire and 2-3 layers of polyester fabric, Imaflexxie - smooth bore PTFE hose reinforced with SS 304 braiding and platinum silicone based outer most cover.

Silicone tube and hoses USP: We manufacture tubing and hoses in clean room of class 10000, which is audited by giant pharma companies like DRL, Shantha Biotech-A Sanofi company, Baxter, Pfizer- Hospira, Bharat Biotech, Lupin Ltd., Sentiss pharma, Microlab Ltd., Fresenius kabi oncology and Mylan Ltd.; our platinum cured silicone tubes/Hoses are registered in USFDA and having DMF#26201; our products have certifications in accordance with regulatory markets like FDA 21 CFR 177.2600, German Bfr XV, France Arrete Du 25, USP class VI, ISO 10993, ROHS COA, TSE/BSE free COA; we have signed quality agreement with TOXIKON corporation for E and L studies on platinum cured silicone tubing; and NSF-51 certification is initiated on platinum cured silicone products. (NSF is US based organisation and 84 per cent standards of USFDA are derived from it.)

Are these products indigenously manufactured or is there any imported component or technology?

We import raw materials from Germany and manufacture the product in our clean room of class 10000 under ISO standards. We have imported machines for extrusion, inspection, cutting and length measuring process. Implemention of online laser inspection based technology for monitor and control of the dimensions. Laser Etching technology is implemented for lot traceability

What is the Company’s history?

The Company Started in 1996, at that time there were not many companies in this segment which can provide the rubber applications solution to pharmaceuticals company. In short the demand was high and supply was low. Companies were preferring the import market for their solution as a result they were getting product after long duration of time. At this point, I found an opportunity to explore this segment of pharmaceuticals sector which can provide them required solution with necessary regulatory compliance.

Any breakthrough product launch that made a difference?

Ami Polymer Pvt Ltd is the only Indian company which has developed heat sealable/weldable tubing for cell culture processing in biopharma applications. Another product introduced is silicone antistatic tube and gasket, its antistatic property dissipates charges through rubber surface and volume. We have developed import substitute tubings and hoses which meets with critical requirement of regulatory markets like USFDA/ UK MHRA. We provide critical products with fastest delivery and at economical prices.

How is present business environment?

The Indian pharma industry, which is expected to grow over 15 per cent per annum between 2015 and 2020, will outperform the global pharma industry, which is set to grow at an annual rate of 5 per cent between the same period. The market is expected to grow to USD 55 billion by 2020, thereby emerging as the sixth largest pharmaceutical market globally by absolute size, as stated by Mr Arun Singh, Indian Ambassador to the US.

India has also maintained its lead over China in pharmaceutical exports with a year-on-year growth of 11.44 per cent to USD 12.91 billion in FY 2015-16, according to data from the Ministry of Commerce and Industry.

The Union Cabinet has given its nod for the amendment of the existing Foreign Direct Investment (FDI) policy in the pharmaceutical sector in order to allow FDI up to 100 per cent under the automatic route for manufacturing of medical devices subject to certain conditions.

The Government of India unveiled ‘Pharma Vision 2020’ aimed at making India a global leader in end-to-end drug manufacture. Approval time for new facilities has been reduced to boost investments.

What are the company’s future plans?

Over the next five years, we will be delivering an ambitious programme to support the industrial growth. Our 2016-2017 business plan is the result of thousands of conversations with our customers, detailed consultations with our vendor, suppliers and core management team. It will see us create jobs and training opportunities; help our most hard-pressed customers; protect and enhance our environment; support economic growth; and improve reliability. Company has applied for TOXICON and NFS 51 certification on platinum cured silicone compound, which will be applicable from 2017-2018. Also the company is expanding its manufacturing facilities and sales office in overseas for tapping the global market.