The pharmaceutical sector is a major water consumer and relies on treatment processes to ensure a safe and secure supply of purified water that meets and exceeds stringent quality and quantity demands. Furthermore, the industry is highly regulated by supervisory bodies such as the United States (US) and European Pharmacopoeia, and every manufacturing facility has a User Requirement Specification (URS) defining the feed-water quality, volume of water and necessary purification steps. Purified water is used in a variety of applications, from production to cleaning reactor vessels, and facilities require a continuous, reliable supply that mitigates the risk of microbial growth and the deterioration of water quality.
The US and European Pharmacopoeia highlight three key measurable variables in water treatment: conductivity, Total Organic Carbon (TOC) and bacteria levels. Water purification for pharmaceutical manufacturing is a multistage process, with reverse osmosis (RO) and continuous electrodeionisation (CEDI) forming the two core processes to reduce conductivity and TOC. Invariably, pretreatment is required for most raw water to protect the RO and CEDI units. This usually includes softening and some form of free chlorine removal. Some customers may choose to install an additional post-treatment process, such as ultrafiltration (UF) steps to remove endotoxins from the water or an ultraviolet disinfection unit as an extra precaution to kill any prevailing bacteria that may have passed through the system.
Further pretreatment purifications steps may also be necessary, depending on the hardness of the raw water supply. For example, water from Suffolk and Norfolk in the UK has a very high conductivity — around 1000 µS compared with 80–120 µS in Scotland. The US Pharmacopoeia calls for water conductivity to be less than 1.3 µS at 25 °C, requiring significant pretreatment of the raw water supply prior to RO and CEDI. Finally, preventing dead legs and ensuring that water is kept moving, as well as using hot sanitisable equipment, are key steps to ensuring that the quality of water is maintained and bacterial growth is minimised. Once a plant has been installed, the FDA, EMA or region-specific equivalent agency audits the facility to see that drug production complies with regulations, and that companies are meeting the day-to-day monitoring and sanitisation procedures.
It is essential that a facility can rely on the quality of water from its purification system, as a single product batch voided by impure water can represent a loss in revenue in the region of a million Euros. The potential disruption and financial impact caused by out-of-specification water quality means that planned equipment maintenance is extremely important. The arrival on the market of rentable, skid-mounted mobile water systems can offset this disruption and provide a source of pharmaceutical-grade water during planned maintenance or a facility upgrade to support continued production.
Plant for hire
During the last decade, an increasing number of companies have created a demand for long-term equipment rental, particularly in cases when the return on capital investment will not be met during the lifetime of the project, and especially if it is a period of less than 5 years. A multi-year “pay-as-you-go” scheme may be the most suitable option, providing a more cost-effective approach to water purification, and enabling the water system to be covered by the operations budget, leaving the capital available for core investments.
In cases when capital investment is the most sensible route, a mobile system can still meet the additional requirements in the interim period between increased demand and a permanent solution being installed. A complete turnkey project can take up to 10 months from initial installation to completion, followed by validation, including performance qualification steps that can take up to 6 months depending on the size of the system. Mobile water systems are already fully validated and can be introduced into the main water purification supply in a 2–3 week timeframe. A final benefit afforded by the rental market is the opportunity for companies to conduct production trials as they monitor the effect of water quality on their manufacturing processes. Temporary treatment plants provide a cost-effective means of finding out whether making a substantial capital investment is worthwhile.
Veolia Water Technologies (Veolia) has embraced the rental market with its ORION-4000S technology — a skid-mounted, mobile unit suitable for water purification in the pharmaceutical industry — in direct response to customer demand. In one instance, a client needed to increase production in response to market demand, and its existing water infrastructure could not meet the water requirements and necessary validation. In another example, a supplier of pharmaceutical-grade plastic foam needed to improve water quality and validation in response to the demands of a multinational client. Flexible hire periods and a pay-as-you-go system, combined with full service and maintenance support, provided an ideal solution in both situations.
New thinking
The rental model may be new to the water technology market, but there is a solid business case for many pharma companies to opt in, whether to cover planned maintenance, deal with an increase in production or simply as a more cost-effective solution during shorter-term projects. Increased options and flexibility in the water technology market can only help to provide the reassurance pharmaceutical companies need that their supply of pharma-grade water is safe, secure and can reliably support continuous production.