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Feature Articles : Apr 1, 2009 ( )
Ongoing Pursuit of Sustainable Operations
Industry Has Embraced All Things Green and Is Operating Ahead of Government Mandates!--h2>
Environmentalism has come a long way since the first Earth Day nearly 40 years ago. After nearly two decades of operating on the fringes, green has entered mainstream public policy and infiltrated nearly every commercial enterprise.
Pharmaceutical and biotechnology operations were slow to catch on. In some respects the former remains dirtier than most industries as measured by waste generated per unit weight of product produced. But the situation is improving rapidly. Every pharmaceutical and biotech company has implemented rigorous, organization-wide directives to conserve, recycle, and minimize waste in every theater of operation, including corporate, R&D, manufacturing, and distribution. And without exception they are uncovering substantial financial savings in the bargain.
This article examines the rationales and strategies for going green at the level of facility, laboratory, and in production.
California Leading the Way
California’s recently enacted green chemistry initiative is expected to set the national standard for green business practices. As Peter Hsiao, a partner at Morrison & Foerster and a specialist in environmental-industry law, notes, “It’s difficult to sell one product in California and another in the rest of the country.” The California initiative focuses mainly on consumer products, and paradoxically exempts pharmaceutical companies. Nevertheless, drug firms have overtaken many industries in their dedication to sustainability and appear to be operating several steps ahead of government mandates.
One component of California’s proposed regulation, which is still in the comment and rule-making stage, is the so-called cradle-to-cradle life cycle management, which promotes the design of inherently green products. “It arises from the idea of moving sustainability up the supply chain, not just at the end of a product’s life cycle, where toxic components remain that may trigger a clean-up obligation,” says Hsaio. The initiative instead provides incentives for companies to design environmental friendliness into the products, a type of green-by-design.
Lean Equals Green
Lean operational strategies, by nature, lower an organization’s environmental impact by minimizing waste and reducing inefficiencies that consume human and natural resources. Streamlining operations, says Mark Butler, GM and principal at engineering firm IPS, is where pharmaceutical and biotech firms should seek environmentally friendly processes that are also profitable.
The next opportunity zone is a facility’s energy utilization. Here, companies need to adopt risk-based approaches to energy that ascertain services can safely be altered or reduced without affecting product quality or worker safety.
Some easy changes involve the installation of premium-efficiency motors that drive numerous plant services such as moving chilled water through the facility or delivering USP water and water for injection (WFI) into upstream unit operation. “There are hundreds of large motors in a typical biotech plant,” says Butler. Premium-efficiency motors cost more, but their payback in reduced energy consumption is generally on the order of one to two years.
When specifying materials for construction or renovation, Butler sources materials and supplies from within a 500-mile radius of the site to reduce transportation-related energy costs. He also seeks out low-VOC glues, adhesives, and paints, and uses materials with a recyclable component whenever possible.
IPS is enthusiastic about disposable process equipment and facilities designed for their use. Disposables provide much-needed flexibility while reducing time and consumption of water, electricity, and human resources associated with cleaning and cleaning validation. It may seem paradoxical that disposable equipment could be considered sustainable, but that is the conclusion most biotech firms reach after comparing the downside of single-use equipment with the energy, effort, and capital expenses associated with hard-piped stainless steel equipment.
In planning retrofit and renovation projects for companies interested in green certification, IPS utilizes a scorecard that follows the U.S. Green Building Council’s Leadership in Energy and Environmental Design (LEED) Green Building Rating System. LEED certification confers prestige, but more importantly signifies that the owner will enjoy significant energy savings over the facility’s life span.
Another green building design strategy involves minimizing the square footage of classified space through the use of isolators. Legacy biotech plants have probably overused classified space to be on the safe side. A risk-based approach might limit classified areas to the most critical operations.
Facilities and General Operations
Although environmentally friendly practices in the past have been heavily shaped by legislation and regulation—normally viewed as economic burdens—green operations almost always reduce costs if executed properly, and may become a profit center. Andy Wells, Ph.D., senior principal scientist at AstraZeneca’s Charmwood, U.K. facility notes, “Greener is often less expensive because it requires less input and generates less waste.”
Like most large drug makers, AstraZeneca’s sustainability programs encompass all areas of operation, from offices and physical plants to laboratories and manufacturing. Each of the company’s U.S. sites has a team that focuses on waste reduction and sustainability and shares best practices with other locations.
One goal is to reduce all types of waste, including hazardous and nonregulated waste (e.g., trash). Reductions in hazardous waste last year equaled 21%, and nonhazardous waste 17%, compared with 2007 levels. AstraZeneca recycles, reuses, or employs as an energy source about 68% of the trash, recyclables, waste pharmaceuticals, and nonregulated chemicals it generates. Eighty-eight percent of the rubble generated from its Waltham, MA, expansion was recycled rather than landfilled.
Several years ago AstraZeneca’s Westborough, MA, manufacturing site used competitive bidding to identify a vendor that could purchase and recycle the company’s plastic waste. Last year, this arrangement earned AstraZeneca more than $600,000 and saved the company almost an equivalent amount in disposal costs.
Bayer HealthCare Pharmaceuticals takes a fence-to-fence approach to environmental efforts that encompasses its offices, R&D labs, and API manufacturing. James Breitlow, who heads health, environment, and safety services at the facility, notes that the connection between green practices and profit at Bayer is strong.
Recycling was one of the first initiatives undertaken by Bayer. Today the company recycles 86% of all the nonhazardous waste it generates, a level Breitlow describes as “phenomenal in our industry.” Part of the program involves products and materials that are, by pharmaceutical industry standards, off-specification. These are either recycled or, in some cases, donated to nonprofit institutions such as schools.
Water consumption at Bayer Berkeley, another target area, was down 7.5% this past year. The site, which manufactures biologicals, uses a lot of WFI, says Breitlow. The company has made a concerted effort to reduce WFI usage, which saves not only water and wastewater generation, but the vast quantities of energy required to generate the ultrapure water.
Breitlow could not comment on the greening of specific unit operations in his site’s biomanufacturing plants, but he did cite implementation of KanBan, a Japanese operational excellence method for managing inventory. This program assures that raw materials will be available at the point of use when they are needed, thereby saving time and energy and preventing excess materials from going into expiry.
Bayer has plans to expand its environmental efforts, for example:
A Green Pedigree
Pharm/biotech companies are discovering that green strategies that work well for existing facilities can be even more successful for new buildings and campuses.
Bristol-Myers Squibb’s (BMS) new large-scale multiproduct bulk biologics plant in Devens, MA, is illustrative. The five-year, $750 million project (the largest in BMS history), was designed with U.S. Green Buildings LEED certification in mind. Since the Devens site is a former military installation, its sustainability mandate was more or less built-in, which fit easily into BMS’ sustainability program. Upon commissioning in 2010, the plant will fulfill production requirements for Orencia, the company’s rheumatoid arthritis treatment through six 20,000 L bioreactors.
The principal environmental challenge for this project, says Dan Noberini, associate director of environmental health and safety at the facility, was to familiarize the architectural and engineering companies with LEED certification. The firms BMS hired had some familiarity with LEED, but not for a project of this size. “The education campaign for our contractors and subcontractors was one of our biggest challenges,” Noberini says.
Access to sunlight was optimized through an open-office design that incorporates no hard-walled offices. Every employee in offices and laboratories enjoys access to some natural light. BMS Devens does not use solar technology, but the facility’s orientation exploits southern exposure to provide free light and heating. Indoors, the facility employs highly energy-efficient lighting, which is both employee-controllable and regulated by sensors.
Up and Down the Supply Chain
Biotechnology and pharmaceutical companies increasingly look to their vendors for environmentally conscious products and practices. Life Technologies has instituted a green strategy covering all of its facilities and entire supply chain. The strategy evaluates the environmental friendliness and operational efficiencies surrounding Life Technologies’ suppliers, R&D, manufacturing, and distribution.
Initiatives include a design for environment program that covers sustainable packaging, green chemistry, product life cycle related issues, and a new program, begun in 2009, that promotes sustainability at the innovation level.
Like every company interviewed for this article, Life Technologies follows a return-on-investment philosophy that delivers profitable sustainability. “We don’t advocate going green only for its own sake,” says Cristina Amorim, senior director, global environmental health and safety.
Life Technologies subscribes to the philosophy that conservation and waste reduction inevitably lead to a lower carbon footprint as defined by carbon dioxide emissions. All efficiencies, in any area of operation, will lead to greater sustainability.
“When we save water we save energy because moving water through a facility is energy-intensive,” Amorim notes. One project involves improving the efficiency of the production of pure water through reverse osmosis. The idea is straightforward: Make the process more productive, and/or reduce water use, and the carbon footprint shrinks. Last year, for example, Life Technologies used recovered water for all its irrigation and landscaping, saving 700,000 gallons of water per month. Another idea is to use recycled water in cooling towers “but not for our products,” Amorim assures.
Partnerships with local water and electric utilities are often overlooked strategies that can help conserve resources and save money.
Life Technologies’ electric company provided experts who conducted an energy audit and submitted a plan for reducing the company’s electricity usage.
The company’s first initiatives involved low-hanging fruit, and it plans to implement more ambitious energy-saving strategies that involve capital expenses later on—or sooner if a tangible return on investment can be demonstrated. “We have saved more than $10 million in energy costs over the last four years,” Amorim says, “but we can do even more.”
Balancing sustainability with safety is a problem facing every R&D or manufacturing company, and Life Technologies acknowledges that. Air exchange is an oft-cited resource hog, with laboratory fume hoods leading the way. While exchange rates can be tinkered with in some parts of a facility, Amorim believes this strategy is not advisable for hoods because of worker safety issues. Here the company is implementing behavioral programs to induce employees to work smarter by lowering the sashes on fume hoods when they are not working in them.
Pharmaceutical and biotech companies have achieved a great deal in the way of corporate and facility-based eco-friendliness. The fact that such strategies can also help their bottom line has accelerated implementation.
Going Green Incentives
Market forces may already outstrip regulations for inducing the greening of pharmaceuticals and biotechnology. While these incentives hold for any industry, the economic incentives for pharma and biotech run even deeper because of their stature within healthcare, and their high cost structures.
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