Water grading
S.B.M.P. Halakatti Corporate QA & RA Head, Granules India |
The pharma industry demands different grades of water to be used depending upon the type of operation. “Quality standards differ by application use. For many APIs that are used in oral dosages, the requirement is for potable water conforming to WHO standards. However, API that is used in parenteral applications require a more stringent specification of purified water. Products such as nasal preparations, tablet coating and granulation also require purified water. Injectables and vaccines have their own specifications which falls under “Water For Injection quality (WFI).” Quality-conscious customers and regulatory agencies are spending larger portions of their audits inspecting water purification systems since it’s an important component of the manufacturing process,” informs SBMP Halakatti, Corporate Quality Assurance (QA) and Regulatory Affairs (RA) Head, Granules India.
Amit Doshi Director – High Purity Water & International Operation, Doshion Veolia Water Solutions (DVWS) |
Amit Doshi, Director, High Purity Water and International Operation, Doshion Veolia Water Solutions (DVWS) says, “Water and air are the two most critical utilities for the pharma industry, and water is often seen as the biggest raw material as well. Thus all pharma industries are highly concerned about water quality across all applications in their consumptions.” He adds, “Globally; there are few pharmacopoeia like US pharmacopoeia, European pharmacopoeia; Japanese pharmacopoeia, Indian pharmacopoeia etc. which are followed for manufacturing of vaccines; syrup and tablets. Yes, some norms vary depending on the products and the country it is to be exported. As per the latest United States Pharmacopeia (USP)32, the parameters for purified water are 1. Conductivity: <1.3 ms/cm @ 25° C 2. Total Organic Carbon (TOC): <500 ppb. 3. Microbial: <100 cfu/ml, whereas for WFI, the specifications are more stringent.”
DVWS is a joint venture between India’s leading water management group Doshion and Veolia Water Solutions & Technologies. DVWS provides complete water management services for pharma industries.
Different grades of water quality are required depending on the route of administration of the pharma products. According to S Sankara Rao, General Manager, Quality Management, Indian Immunological Limited (IIL), companies wishing to supply multiple markets should set specifications that meet the strictest requirements from each of the relevant pharmacopoeias.
Rao says, “Control of the quality of water throughout the production, storage and distribution processes, including microbiological and chemical quality, is a major concern. Water is used on demand and hence not subjected to testing and batch or lot release before use, therefore has to meet specification “on demand” when used. Micro test results require incubation periods.
Other usages of water
Kishor Datar Chief Technical Officer, Technolutions Projects |
Though water has major applications in manufacturing there are many other areas where its use proves critical. According to Kishor Datar, Chief Technical Officer, Technolutions Projects, water is predominantly used in cleaning. “Today, clean in place (CIP) are the norms used and water is extensively used for this,” informs Datar. Doshi adds few more usages of water in the pharma industry, “Besides manufacturing, water is used as utility (boiler and cooling tower make-up, heat exchanger), reactor’s cleaning, drinking, horticulture, gardening, and other general purposes.” According to Halakatti, water has a use in quality control while analysing raw materials and finished goods.
Processing technology
An usage of water varies depending on its application and different processes are implemented in the pharma industry to treat it. Treating water is an extensive process and involves several stages. Every pharma company will have a dedicated water treatment plant. Halakatti describes in detail the steps involved in water treatment, “First, there is a pretreatment phase where water is filtered and processed through carbon treatment. After that, water is de-mineralised to remove hard minerals in the water. Next water goes through reverse-osmosis, which is a way to desalinate the water. Afterwards, water goes through UV treatment to remove microorganisms. Finally, water goes through electrodeionisation (EDI) which removes ion.” According to Halakatti, while there are several complex steps, the takeaway is that water treatment is an exhaustive process. Water treatment is a critical step in the manufacturing process and if it is not done properly, it can lead to multiple quality issues.
Doshi informs, “All validation protocols starting from design qualification, installation qualification, operational qualification and finally performance qualification are being followed before purified water is qualified for use in manufacturing process.”
Datar explains, “Many steps are followed to process water. They mainly depend on input water quality and out-put quality expected. Various treatment schemes like CLO2/Cl2 dosing, de-ionisation/ carbon bed/ multi grade filtration/ softener/ UF/ RO/ EDI/ multi column distillation/vapour compression distillation etc. are used.”
Effluent recycling
Chemicals are widely used in the pharma industry. They are also an important constituent of the effluents. These effluents are hazardous to the environment. There are provisions to treat this water to minimise or to avoid the damage to the external environment. If effluents can be recycled and reused, it will save water and money as well as make the company more environment friendly.
“There are several ways to treat water including aeration technique, trickling filtration, evaporation and chemical treatment. Many companies do basic treatment and send effluents to a common treatment plant for safe disposal,” says Halakatti. He highlights that effluent treatment is critical, and many customers, particularly in the regulated markets, demand to know that their suppliers are treating waste water and safely disposing it.
He adds, “Water usage efficiency will become more critical in the future which is why Granules’ API R&D team is working on next-generation manufacturing processes which will improve yields and reduce effluents.”
Doshi says, “Effluent treatment is varying from customer to customer but looking at the water scarcity and reliable unique technology available now in India most of the pharma companies are now going with recycling.” DVWS offers various anaerobic and aerobic technologies specially for the treatment of high organic (Biological Oxygen Demand (BOD), Chemical Oxygen Demand (COD), Total Organic Carbon (TOC)) pharma waste water. These technologies are well proven and widely used in majority of leading pharma companies across the globe.
“When it comes to recycling, yes it (water) can certainly be recycled with the proper tertiary treatments and used for the various utility applications like gardening, flushing and cooling tower make up. In fact we have very unique installations in India, already in operation, offering total water management concept up to zero liquid discharge, thereby enabling less water consumption and also effluent discharge/ environmental hazards,” informs, Doshi.
According to Rao, waste water is treated using Effluent Treatment Plants (ETP). Industries/ regulations are now moving ahead with new generation ETP’s with zero discharge of effluents. Vaccine manufacturing plants use kill tanks (to decontaminate live bacteria, recombinant bacteria and virus cultures {post inactivation}) before ETP. Also sewerage water treatments (STP’s) are in place in the industry.
Pharma industry is a place where innovation is the norm. In the coming future, various new products will be discovered/ introduced globally and in India. While medicines are undergoing evolution, water processing technology will also complement the wave of change.