These Five Trends Suggest They Are.
Background
#Waterquality requirements for pharmaceutical processing have not changed significantly as treatment technologies have improved. Coupled with a perception that systems must be designed and operated in accordance with regulatory expectations, the #pharmaceuticalwater industry has historically been slow to adopt new practices or novel processes. Instead, the focus has been on refining existing materials and devices, and the industry has been dominated by the use of stainless steels and hot water sanitizable components and materials.
In the #microelectronics industry, where higher water quality is required to prevent contamination during device processing, there is an ever increasing demand for cleaner water. To meet the more stringent requirements at points-of-use, microelectronic water systems require polishing techniques to deliver water for use to avoid quality degradation. They employ hygienic plastic piping materials of construction and rely on real-time process analytics to ensure quality.
Recently, an increase in non-traditional approaches to the design and operation of pharmaceutical water systems mirror those utilized in microelectronics water processing.
Trends in Pharmaceutical Water Process Design
1. Polishing techniques in storage and distribution systems
Polishing is a generalized term used to describe supplemental techniques used to further purify water after a primary deionization process. Typical polishing techniques may include deionization, UV light, or submicron filtration. Pharmaceutical water systems would generally store and distribute without polishing due to the less stringent quality requirements and perception that the process would draw regulatory scrutiny. Recently, the use of polishing has become more commonplace especially in #USPPurifiedWater Systems.
2. Ozone sanitization
Ozone has been successfully employed for sanitization of USP Purified Water Storage and Distribution Systems for some time. The emergence of automated continuous ozone for #WFI systems is only recent due to new regulations in the European Monograph concerning WFI production. Many companies have adopted the use of continuous ozone as an alternative to heat disinfection to save sanitization downtime, and capital and operating costs.
3. Plastic piping systems
Plastic piping systems are becoming more common for pharmaceutical water applications especially for USP Purified Water Systems. Driving factors include the rise in stainless steel prices, increased availability of fittings and valves, and acceptance of automated hygienic pipe welding machines. The increase of polishing components in the distribution loop has led to more chemically sanitized plastic piping systems because of the ability to extend time intervals between sanitization.
4. On-line and inter-component monitoring
There has been an increased focus in the industry to improve the monitoring throughout the entire pharmaceutical water treatment train and not just relying on end-point testing to ensure quality. Many companies have implemented inter-component monitoring programs and regularly sample or analyze after each unit operation in a system. This can be done my grab samples or on-line instrumentation for key process parameters. This practice can be critical to predicting upsets or changing conditions before the end product is affected.
5. Use of ultrafiltration
The use of ultrafiltration in the pharmaceutical processing industry is not new, but more applications are now focused on pure water systems as well. Ultrafiltration (UF) can be used to treat feed water and aid in the reduction of suspended solids, organics, microbials, and endotoxin. It can also be employed as a polishing technique for bacterial and endotoxin removal. UF has recently become widely used as a terminal membrane barrier in non-distillation based systems for the production of WFI.
Reasons for Trends
Several factors are driving the changing paradigm for pharmaceutical water design and operation. There is less emphasis on meeting perceived regulatory expectations as companies adopt a science and risk based approach for these systems. This is helping to change or eliminate some longstanding traditions that have been in place for decades in the industry. Engineers are looking to the successful practices of other #highpuritywater industries such as microelectronics and finding that systems can generate and deliver ultrapure water quality with very low bacteria and endotoxin without excessive heat sanitizations.
Current trends are also being driven by the need to reduce system operating and capital costs. Successful designs include using sanitization techniques such as continuous ozone that use less energy, and by reducing the frequency of sanitizations by incorporating additional polishing techniques for microbial control into the design.
The Future of Pharmaceutical Water Systems
While some of these trends may continue in the future, we predict the following items could disrupt the pharmaceutical water industry in the future:
More disposable technology (less cleaning and sanitization)
Less customization of unit operations. Systems conservatively designed to operate on a wide range of feed water supplies
More membrane based systems including the use of low pressure RO or nanofiltration
Increase use of process analytical technology including on-line monitoring to make real time adjustments to process variables. This will ultimately include on-line bacteria and endotoxin testing.
Point-of-use filtration. With the current uptick in the use of submicron filtration in the distribution loop piping, the next logical step would be to allow for terminal filtration at the points-of-use.
Regardless of what the next impression or development is in the industry, hopefully focusing less on meeting regulatory expectations. This will lead to new, commercially successful, cost effective technologies and solutions enjoyed by other high purity water industries.
