Purified water is a vital component for the core cleanroom technologies. And this is where the Bangalore-based Ion Exchange Services Ltd (IESL), an associate company of Ion Exchange (India) Ltd, comes to the picture in the clean room equipment industry. IESL , the largest organized service network in water treatment industry across Asia, is a leader in providing services for any make and type of water and waste water treatment plants in India and overseas across diversified sectors including pharmaceuticals and hospitals. The company which has done a lot of work for the pharma industry , sees a lot of opportunities for its services in this sector in the coming years, says Dinesh Sadasivan, Executive Director and CEO, ION Exchange Services Ltd in an email interaction with Nandita Vijay .Excerpts:
Can you elaborate on the uses of pure water in pharma cleanrooms?
There are different quality of water used for production, namely : WHO standard as per drinking water quality used for general purpose use. The other is as per USFDA- USP 34 norms for purified water for production and final rinse purpose. In addition to this we also have USFDA – USP 34 norms for water for injection for production and final rinse purpose.
Pharma companies demand maximum purity of water to meet high quality standards. How do you ensure quality standards for supply to pharma units?
The generation of purified water treatment is bifurcated into below three categories of purification to remove the physical, chemical and biological impurity.
Generation system
- Pre – treatment to remove physical, microbial and partial chemical removal /separation using various equipment like chlorination/filtration/ softening /ultra-filtration/primary reverse osmosis systems.
- Process treatment to remove chemical impurities using reverse osmosis/ carbon di oxide removal using mechanical type degasser or membrane degasser/continuous de ionizer system using electricity/demineralizer using chemical method.
- Post treatment – Polishing for chemical removal using post ultra filtration system/ ultra violet system
Storage & distribution system
After generating the purified water, it is important to store the water in a storage tank and distribute purified water to various process used in the production/quality/R & D /batch production etc. This is done by using highly polished surface using electro-polishing method in the storage tanks, piping, pumps and other components to avoid any bio film formation the circulation loop. The state- of- art design is highly specialized engineering design using various components & instruments to control & maintain the purified water which is a challenge.
What is the importance of water management in the pharma industry?
The pharma industry utilizes many grades of water. Purified water is the most extensively used grade and water for injection, which are used for compounding and cleaning. It is due to the potential for microbial growth which could come through de-ionization, ultra-filtration and reverse osmosis systems that water management services plays a crucial role to ensure all the water systems are properly maintained and to ensure water quality specifications are within the limits of design.
How would you describe the current scene for water purification and treatment in India?
The water treatment market in India is growing at a healthy pace with the higher investments in the municipal and infrastructure sector. In the industrial sector-pharma, F&B and power will be sectors that will contribute to this growth.
What are the challenges before companies to grow in this space?
The challenges to grow in the sector is to have the ability to service customers post sales. We will also need to adapt and provide solutions to water and waste water issues with new technologies. There is also need for considerable investments in research and development and process application development.
How has the small and medium scale sector of the pharma industry responded to the need for water treatment options?We have a diverse range of products to produce purified water which are fully automatic, user independent , prevalidated with validation pack and need minimum time for doing IQ and OQ .
The small and medium segment of the pharma industry which earlier used the manual conventional systems for water treatment have now started using Ion Exchange's SWIFT system which meets all the above requirements. Many of them have also upgraded to RO EDI technology which is fully hot water sanitisable, pre-validated & a chemical free system.
The effluents treatment plants have been posing a serious problem for many companies. What is the company’s expertise to solve the problem?
ETP in the pharma industry is a bigger challenge than any other industry because of a variety of complex drugs manufactured. Also, in a day a typical pharma factory may produce different drugs hence, the nature of the effluent changes on a daily basis .
In order to understand such complexities, we believe in first undertaking piloting and then arriving at the most optimum solution for the company. This can be an aerobic or anaerobic process etc.
What are the latest developments at Ion Exchange in terms of investments and new projects?For Ion Exchange, the pharma industry has always been a key focus area. Our speciality resin manufacturing facility which produces excipients (used in the final formulation) and drug actives have always been a major focus area . Both of these fall under the highly specialized category. We are currently investing in upgrading our factory at Ankleshwar which will help us to gain access to some of the most difficult international markets such as the US with respect to products for the pharma industry.
We have also invested heavily in our R&D facility at Patencheru to facilitate research on new applications for our product range and meet the stringent quality parameters set by our customers. Our factory at Hosur which produces engineering systems like ROEDIs , SWIFT System & their distribution systems in SS 316 L MoCs too has undergone a change. These systems produce purified water (as per the US Pharmacopeia standards) which goes as an ingredient in manufacturing formulations.
Hence, our focus as a water treatment company is not only restricted to water but also specialty applications in the pharma industry.
The domestic or international market which holds more promise for Ion Exchange? Both the domestic as well as the international markets are growing markets.
What is the size of the water treatment business in India and global markets which the company is targeting? While we are active across all sectors of the water space in India (home, industry and municipal), our focus continues to be the industrial water treatment and waste water treatment space. The overall market for industrial and municipal water and waste water treatment is estimated at around Rs 15,000 crores. The markets for industrial water and waste treatment systems is around Rs 5000 – Rs. 6000 crore and Ion Exchange continues to have a healthy share of the market. In global markets, we are focused on a certain selected breadth of products in certain focused geographies.
Has the economic slowdown affected the orders from the global markets?Our focus on global markets is on certain select products and in select geographies like South East Asia, the Middle East, South and East Africa and the North American continent. The slowdown has impacted businesses in certain areas which are more or less compensated by businesses from others. For example investments in the oil sector in the Middle East have not been affected much.
What are the benefits for global customers to opt for your service and what kind of economies- of-scale are they expected to achieve?
All our customers look for products that meet global standards of construction and design and performance which ensures that they remain competitive in a global market and backed by service support that they can count on. Economies -of -scale in that sense becomes important because speed of standardization and product delivery, a service network that is easy to reach are crucial in this industry.
What are the key technologies used to drive your business?
The key technologies are resin - based systems , membrane- based systems like ultra filtration , reverse osmosis , speciality chemicals for conditioning boilers & cooling water treatment , effluent treatment & recycling which is becoming important day by day …..and services to back them up are our major business drivers.
Has the company gone for transfer of technology pacts or is indigenized?Most technologies are either developed indigenously based on market feedback and customer needs at our centres of innovation. However, in specific cases where such products exist in other markets and which have merits, we prefer to work on a technology transfer arrangement or a joint venture.