Reprinted from PHARMACEUTICAL ENGINEERING industry interview The Official Technical Magazine of ISPE January/February 2013, Vol 33, No 1 ©Copyright ISPE 2013 www.PharmaceuticalEngineering.org Pharmaceutical Engineering Interviews George Gsell, President, MECO, Inc. G eorge V. Gsell is President of Mechanical Equipment Company (MECO), a leading manufacturer of engineered equipment for water purification. The firm has an 80-year history and a broad base of products for desalination and water purification. Gsell has more than 25 years of experience designing and constructing a variety of technologies for desalination and water purification, including vapor compression plants, multiple effect, waste heat and flash distillers, reverse osmosis plants, and enhanced membrane systems using micro- and ultrafiltration membranes. His experience includes applications throughout the world in the offshore oil and gas industry, onshore refining, biopharmaceutical applications, municipal water treatment, and state of the art military applications. He holds an MS in desalination technology from Glasgow University in Scotland and a degree in mechanical engineering from Tulane University. He is the author of several patents and papers in the industry related to desalination and water purification. MECO is focused on water and water is a critical utility in the pharmaceutical industry. Can you tell us about the firm and its role in the industry? MECO invented and patented the vapor compression process for the desalination of seawater in the early 1940s. Through the years, we have been developing technologies and systems for various industries such that these industries can meet their needs for fresh water. The vapor compression process is the most energy efficient method of distilling water and so the pharmaceutical industry began adopting the process for the production of water for injection in the early 1960s. In the 1970s, membrane processes such as reverse osmosis began to see widespread use. Today we manufacture a broad range of products that can deal with any water source for any industry. Our focus is primarily on customers who require a very high quality of product with the need for excellence in the execution of their project or delivery of their product. Describe your professional development, your relationship with ISPE, and your role at MECO. I have been designing and building various water purification technolo- gies for close to 30 years. I have had the very good fortune to work with some of the pioneers in the business and today remain surrounded by a very talented team of people. I have had the opportunity to travel the world and get involved in a lot of water related problems and issues. As President of MECO, my role today is more focused on the long-term development of the business, process control, and administration. I engage our customer base directly on a routine basis and work on building a foundation for the learning and growth of our employees. My relationship with ISPE began about 20 years ago both as an educator and one who was being educated. I gave a few talks on water and in the process, learned more and PHARMACEUTICAL ENGINEERING January/February 2013 1 industry interview more each day about the pharmaceutical and biotech industries. Today we have a number of people engaged with ISPE and the document team for the ISPE Guide on Biopharmaceutical Process Development and Manufacturing. You will find us participating in various conferences, contributing to the ISPE Baseline® Guide on Water and Steam Systems Guide, and authoring technical papers. Through the years, we have patented several processes for the production of water to USP purified and water injection standards. Was the ISPE Baseline® Guide on Water and Steam Systems or any other ISPE Guide used in any of these projects? The ISPE Baseline® Guide on Water and Steam Systems has been a tremendous resource for us and the industry as a whole. Some of our people have been participants in the development of the Guide over many years. The Guide serves all of us (designers, contractors, vendors, regulatory officials) as a reference tool. We use the Guide continuously as a resource in designing and constructing systems, as well as educating the industry. Water has captured everyone’s attention today. Can you tell us why? Give us your perspective. Freshwater is a limited resource. Severe weather patterns have impacted the hydrological cycle such that existing supplies are stressed. The world population is growing and with that growth comes not only the increased demand on freshwater sources, but also the contamination of existing supplies through industrialization. Right here in our home state of Texas, we built a multimillion gallon per day reverse osmosis plant to treat groundwater that had been contaminated by farm runoff posing a health hazard. Water is a resource we often take for 2 January/February 2013 granted, but if you look a little deeper, you will come to realize that industry consumes and wastes vast amounts of freshwater to deliver the goods and services we routinely use. The pharmaceutical industry is no exception. MECO is building a new manufacturing facility here in the US that will serve the biopharmaceutical industry. Why here, why now, and what is special about this new facility? Our principal manufacturing facility was located in New Orleans, LA and destroyed by Hurricane Katrina seven years ago. Eighty percent of our employees lost their homes and the communities they lived in were utterly devastated. We quickly opened two new facilities in the aftermath to meet the needs of our customers and provide our employees with continued employment. Both of these facilities are now at capacity. The new facility will significantly increase our manufacturing capacity. It will be a state of the art facility for the machining, fabrication, and assembly of pharmaceutical water projects. Louisiana is a great place to work. The workforce is highly skilled and there are meaningful incentives to do projects there. Our new facility will be in Covington, LA, a New Orleans suburb located to the north of Lake Pontchartrain. Building in Louisiana is a way for us to help rebuild the community. How does the pharmaceutical industry compare to others in considering their need to purify water? The pharmaceutical and biotech industries are very different relative to others when it comes to many things including water. Regulations require us to start with source water that meets drinking water standards. Most other industries start with much more difficult source waters. Having said PHARMACEUTICAL ENGINEERING that, producing water to the Pharmacopoeia standards can be every bit as challenging and expensive. The water quality standards are high and the monitoring is more intensive as is the documentation. Regulations do not allow us to add substances, so where a simple chemical treatment step might otherwise be used, the pharmaceutical industry requires us to add additional unit operations. The manufacturing standards are significantly higher than that of general industry. “ In the short term, I think all of us can review our unit operations to look for opportunities to increase water recovery rates. In so doing, it is likely we will find reductions in energy usage as well. What other industries do you serve, how do they use your products, and are there any lessons or opportunities these industries can offer the pharmaceutical industry? Although we serve a variety of other industries, I think the pharmaceutical industry can and will benefit from our work with the armed services. We have a long history of contracting to the US government and armed services because water is one of the largest logistical burdens on the battlefield. Right now we are under contract with the US Army, the Navy, and the industry interview Defense Advanced Research Projects Agency (DARPA). Several years ago, the Army commissioned us to design and develop a highly capable and mobile water purification unit. Today, these machines are produced in our Texas facility and hundreds have been deployed to Iraq, Afghanistan, and elsewhere in the world. DARPA’s mission is to ensure that our soldiers are never behind the technological curve, so they have commissioned us to develop the next generation of highly capable water purification units. Navy ships today operate closer to shore and in littoral waters that are troublesome for conventional desalination plants. Given this, the Navy has engaged us to design and develop an advanced shipboard desalination plant to meet their very special needs. The technologies funded, developed, and proven under these programs are done so to resolve fundamental issues that are in some cases common to other industries. The pharmaceutical industry wants lean processes and the technology being deployed and developed will result in improved water recovery, lower energy consumption, higher reliability, lower maintenance, and zero operator involvement. Where do you see opportunities for advancement with respect to water within the pharmaceutical industry and what role can industry play in considering the larger water issue? Water is the most prevalent ingredient in the drug manufacturing process and the pharmaceutical industry wastes an exceptional amount of water. Typically more than 25% of the feed water is rejected to waste immediately in the purification process given a variety of unit operations. Further down the line, often, only a fraction of the ultrapure water is used in the final product. In some cases, more than 90% of the freshwater (drinking water quality) supplied to a pharmaceutical water system goes down the drain. Although the technology to recycle and reuse the water is available, regulations and aversions to risk prevent us from doing so. In the short term, I think all of us can review our unit operations to look for opportunities to increase water recovery rates. In so doing, it is likely we will find reductions in energy usage as well. Longer term, I think we need to tackle the issue of recycling and educate one another on the opportunities to do so. ISPE has been a tremendous resource for sharing of best practices such that the process of change does not necessarily have to be accompanied by the unknown. The ISPE Baseline® Guide on Water and Steam Systems is another excellent resource for information. It is incumbent upon us to be good stewards of our natural resources and be leaders setting an example. In considering the production of water, what technology advancements are out today that could be of benefit to the industry? Micro- and ultrafiltration refers to a method of particulate removal. The generic process is not new and many of us are familiar with the single use cartridges used throughout the industry. The use of advanced microfiltration and ultrafiltration membranes with respect to water purification has seen exponential growth over the past 10 to 12 years, but we have not seen them widely adopted in pharmaceutical plant water systems. These membranes have the ability to be backwashed regularly, are chlorine tolerant, and offer very high recovery rates. In some cases, applying this technology can eliminate other processes or reduce the sizing of downstream processes while improving overall water quality within a system. Given the fundamental issues surrounding water around the globe, what solutions are on the horizon? We have been “stuck” on the use of reverse osmosis membranes for the removal of dissolved ions from water for 40 years. The principals of operation dictate certain minimum thresholds for energy consumption we just cannot get around. There are other issues around fouling of membranes and rejection rates that are undesirable and expensive. There is a tremendous amount of research underway through governmental programs, universities, and private industry. Much of it is devoted to alternative, far reaching techniques to lower the cost of water production such that it can be more economical to produce for those in need. Selective ion removal through the use of carbon nanotubes is one area that is garnering a lot of attention and money. If the theory in this area can be transformed into reality, it could have a tremendous impact on how we purify various fluids. MECO recently launched a “Sustainability Initiative.” Can you tell us a little about that and how you are implementing the initiative? It started with the building of our new plant and our intent to be environmentally responsible with respect to our own use of water, the land around us, and the way we operate. As it turns out, we are really just committing to policy what we are doing for industry every day. We are always trying to find a solution that makes sense given the challenges. Purifying water is expensive and the operational costs over the life of a plant are many times the plant’s first cost. So, in considering what we do for industry, we are always trying to improve energy consumption and reduce the water footprint. When we are successful, both the percentage and absolute value of the impact is significant. PHARMACEUTICAL ENGINEERING January/February 2013 3