The world over, the pharma industry which earlier had the dubious distinction of being a major polluter of water, land and air, is fast inducting technologies in containing pollution. With the stringent regulations now in force, the pharmaceutical manufactures all over India are fast adopting advanced water treatment technologies such as zero liquid discharge (ZLD) equipment that plays a key role in controlling water pollution in the country. Major industrial states like Maharashtra, Gujarat, Andhra Pradesh, Karnataka and Tamilnadu are not far behind in inducting these systems.
For many years’ pharma and bulk drug industries in the country had not bothered to streamline systems or to install advanced water treatment equipment. Due to this, the harmful chemicals that are let into the drainage and local streams had polluted freshwater bodies in various parts of the country.
With the beginning of the globalization and economic liberalization during the 1990s onwards, in Andhra Pradesh alone the bulk drug industries had contaminated waters in the lakes of Pathancheru, Durgamcheru, Hussainsagar, and other small and medium lakes in just 5-6 years, prompting the Supreme Court ordering ban on expansions until 2013.
Due to the irresponsible attitude towards the society, the pharma industry lost huge opportunities of growth and expansion which could have yielded them huge profits if only they had installed the zero liquid discharge equipment for treating polluted water emanating from the plants.
Though late but grown wiser by experience, the bulk drug and pharmaceutical industries in Andhra Pradesh have now realized the importance of treatment of waste water before releasing it into the drains. Many have installed most sophisticated zero liquid discharge equipment that are most critical in recycling the polluted water and reusing it for the industrial purposes.
“Almost all the major bulk drug and pharmaceutical industries like Dr. Reddy’s, Hetero, Aurobindo, Matrix (Mylan), Divis, Natco etc have installed zero discharge equipment and following all the standards set by not only the government of Andhra Pradesh but also is abiding by the stringent USFDA regulations. As Andhra Pradesh is a major bulk drug exporter, no industry wants to take a chance and everyone is taking care for reducing effluents by either installing advanced water treatment plants or by diverting them to common effluents plants,” said Capt V.V.S.K. Sastry, Assistant Secretary General, BDMA Hyderabad.
Zero Liquid Discharge plants are considered as one of the best systems to employ the most advanced waste-water treatment technologies to purify and recycle virtually all of the waste-water produced. ZLD systems are beneficial to industrial and municipal organizations as well as the environment because of the money saved and no effluent or discharge is left over.
Companies like Siemens, Transparent energy systems, Aquashakti water solutions, Ultra Wa-Tech systems etc are providing equipment for industrial and municipal plants to effectively re-use their waste-water effluent in order to achieve zero liquid discharge.
ZLD systems provide many economic and environmental advantages for plant managers. With the effective performance of ZLDs, water is recycled and reused which will save on the cost and treatment of raw water. Since all water is reclaimed, no effluent is discharged from the plant, avoiding the cost of environmental impact.
The ZLD technology is particularly appropriate in water-short areas and has applications in varied areas like biological treatment systems, physical/chemical treatment systems, conventional filtration systems, membrane filtration and separation systems, chemical feed and disinfection systems etc.
Today the Andhra Pradesh bulk drug industry which manufactures the active pharmaceutical ingredients (APIs) stands as a backbone with over Rs 45,000-crore of pharmaceutical production from the state. All the major formulations companies like Dr Reddy's Laboratories, Aurobindo Pharma and Mylan have their API facilities. Companies like Divi's Laboratories, Granules India and Hetero Drugs heavily make APIs in addition to formulations.
According to Bulk Drug Manufacturers Association (BDMA), a significant portion of AP’s pharma business comes from bulk drug operations, which stands at Rs 19,258 crore, while the formulations comes on top with Rs 25,998 crore.
Since the past few years, many bulk drug units in Andhra Pradesh have adopted new and advanced water treatment technologies which have been reflected in the statistical analysis of the experts. Industry representatives have claimed that chemical concentration data compiled at common effluent treatment plants showed a lot of progress compared to what it was in the last decade in addition to the individual efforts made by big companies.
“Because of the efforts of the industries in reducing pollutants by installing advanced treatment facilities, the state government has also agreed to lift the ban on product expansions. This is really an encouraging move by the state government. Today, major pharmaceutical companies based in Hyderabad have installed systems like strippers and multi-effective evaporators and some had set up the partial ZLDs with only waste water generated from non-chemical use being sent to common effluent treatment plants,” added Sastry.
Currently 49 out of the 169 USFDA approved facilities in India are located only in Andhra Pradesh. This reflects the higher regulatory compliance by the companies. Realizing this, the state government had lifted the ban on expansion of existing bulk drug and its intermediate manufacturing units as they are all having zero liquid discharge facilities.
Water treatment crucial in pharma industry
As water is a critical ingredient in pharmaceutical and chemical manufacturing operations, treatment of water before utilizing it in various process of manufacture is of utmost importance.
Consistent and high-quality supplies are needed for a range of purposes including production, material processing and cooling. As disruptions in raw water supply represent a significant concern, more companies are turning to water efficiency initiatives to help mitigate water scarcity-related risks.
Especially in the pharmaceutical and chemical industry, a wide variety of products are made which requires large volumes of chemicals, materials, and substances that are used throughout process operations. Waste streams generated in these industries can be heavily laden with contaminants, toxins, nutrients, and organic content, presenting unique challenges in terms of treatment, especially as regulations become more stringent.
“More plants in the chemical manufacturing industry are finding ways to recycle water from waste streams for reuse in plant processes, says Dr. Ram Venkatadri, global marketing manager for industrial water in the Energy Group of Pall Corp.
According to Dr. Ram, limitations of raw water are posing a serious business risk as many facilities are located in arid regions that are prone to disruptions in water supply. Therefore water recycling is gaining prominence in this industry as it enables plants to mitigate water shortage risks and become less dependent on raw water supplies. Thus every industry dealing with manufacture of pharma products must and should have sophisticated water treatment plants to meet their requirements.
Types and standards of water
There are two basic types of pharmaceutical water; water for topical use or cleaning (sterile purified water, or PW), or water for injection (WFI) which includes sterile water for irrigation and most sterile water for inhalation.
For PW, USP guidelines require a conductivity limit of 0.6–4.7 µS/cm, a total organic carbon or total oxidizable carbon (TOC) limit of 500 ppb (µg/L), and a bacteria-count limit of 100 cfu/mL.
For WFI, the USP guidelines require a conductivity limit of 0.6–4.7 µS/cm, a TOC limit of 500 ppb (µg/L), an endotoxin limit of 0.25 endotoxin units/mL and a bacteria-count limit of 10 cfu/100 mL. The main difference between PW and WFI is the amount of bacterial contamination allowed, measured by colony count and by endotoxin level.
Methods of water treatment
There are various methods being adopted by industries in dealing with treatment of water at different stages depending up on their relevance. Every water treatment plant is unique, but may include a combination of these methods such as multimedia filtration, Activated Carbon (AC), Ion Exchange (IX), distillation, reverse osmosis, softening, cartridge filtration, UV radiation and electro de-ionization (EDI) etc.
Multimedia filtration: Multimedia filters are designed to remove the bulk of suspended contaminants whose size exceeds 10–30 µm.
Activated carbon (AC): AC beds, also known as activated carbon filters, most commonly are used to remove chlorine and chloramine compounds from feed water. This filtration process protects downstream equipment such as RO membranes and IX resin beads from the damaging oxidizing action of chlorine and chloramine compounds.
Ion Exchange (IX) units: IX technology exchanges undesirable feed water cations and anions with desirable cations and anions. Cations are positively charged atoms and molecules. Anions are negatively charged atoms and molecules. Cation IX units exchange undesirable feed water cations such as calcium, magnesium, lead, and copper with desirable hydrogen ions. Anion IX units exchange undesirable feed water anions such as chloride, sulphate, phosphate, and nitrate with desirable hydroxide ions. The resulting hydrogen and hydroxide ions then combine to form water.
Distillation: Distillation units heat the feed water to its boiling point. Most dissolved and suspended contaminants remain in the water phase. The steam that is produced is condensed and typically meets WFI and PW standards.
RO water treatment: Reverse Osmosis (RO) water treatment has become the standard at many pharmaceutical water treatment plants. RO technology can be a cost -effective replacement for dual cation and anion IX units.
RO systems reduce the need to use costly chemicals, especially those that are caustic, and they curtail the ever-increasing cost of regeneration waste disposal. The payback that results from using an RO system can be achieved in less than two years in some situations. An RO membrane system can remove as much as 98–99 per cent or more of all dissolved contaminants and can remove essentially all suspended (particulate) contaminants.