The concept of sustainability has evolved over the past few decades to describe conditions for harmonious coexistence of industry and nature while meeting socioeconomic requirements of present and future generations. For this environmentally focused report, I like the simple definition offered by Armstrong International, a provider of steam, air, and hot water systems that improve utility performance, lower energy consumption, and reduce environmental emissions. According to a brochure that in part describes its work with Pfizer, Armstrong defines this concept as “meeting the needs of current generations without compromising the needs of future generations.”
In theory, that may imply an “either–or” situation: That is, either a facility/process is sustainable, or it isn't. (And you could argue, then, that nothing truly is.) But in practice, moving from an unsustainable past toward a sustainable future in business is more of a continuum as companies take steps toward more environmental responsibility over time. Many are beginning to understand that considering the environment doesn't have to add cost; it can improve efficiencies as well as public perceptions by decreasing use of materials and reducing negative environmental impacts, ultimately increasing shareholder value over the long term. Relatively sustainable development can be accomplished by understanding the flow and costs (more than simply financial) of all process inputs and outputs, building systems that can adapt to changing needs, anticipating and managing variability and risk, all while earning a profit.
Biopharmaceutical manufacturing is no stranger to regulatory concerns. All facilities must at least go through the motions of basic environmental assessment to meet EPA and local requirements. But 21st-century business is placing increased emphasis on sustainability, due not only to public pressure, but also a world of decreasing resources. This special report considers how the bioprocessing industry is beginning to incorporate related ideas into its processes and facilities. What degree of sustainability is realistic to strive for? What hidden costs of not modernizing do companies tend to miss in their evaluations, and what are the real economic advantages of going green? How are companies comparing “apples to oranges” costs of, for example, water for injection (WFI) production and clean/steam-in-place operations with those incurred in securing an uninterrupted source of disposable materials? Where are the tradeoffs specific to various methods of disposal, and how are they to be evaluated? And what lessons can the US biotech industry learn from attention paid to this topic by many European companies and regulatory agencies?
FW Biokinetics (www.fwc.com) is an engineering and design firm providing construction and validation of biopharmaceutical and vaccine facilities worldwide. The company lists environmental sustainability as one of six major trends in the industry today — alongside outsourcing growth, financial pressures, regulatory pressures, mergers and acquisitions — so it offers guidance in this area as one of its services.
“Green is here to stay,” states the corporate website. “But so much of sustainable design is simple engineering attention to detail, things we already know: saving energy, utilities optimization, water temperature, air handling, process automation strategies.” FW reports that one of its major pharmaceutical clients wants to become a leader in sustainability over the next couple years and expects the effort to cost an additional 2–3%. But the long-term benefits will dwarf that investment.What Vendors are Doing
Early in the ongoing single-use revolution, companies offering disposable equipment and components were faced with the inevitable question: Isn't this simply going to increase the amount of plastic waste going to our landfills (1)? Many of us — myself included — who followed the industry's continuing foray into single-use technology raise environmental concerns the moment we hear the word disposable. Perhaps that's one reason the Bio Process Systems Alliance, BPSA, has made efforts to nudge us all away from the term. And perhaps it has something to do with the very public efforts makers and sellers of such products are putting into sustainability research and initiatives.
Going Solar: For example, NewAge Industries is a manufacturer and fabricator of polymer tubing. Its AdvantaPure brand is familiar to many people in the bioprocess industry. The company recently completed installation at its headquarters of a 1-MW rooftop solar panel system, the sixth largest in Pennsylvania. Since going online in June 2011, the system is supplying half the company's energy needs.
“To see what you've done here is quite phenomenal,” said US Representative Mike Fitzpatrick at the ribbon-cutting ceremony. “You're demonstrating an example a lot of other manufacturing organizations should take a look at.”
The solar project was financed in part by a US$1 million solar energy program grant from Pennsylvania's Department of Community and Economic Development. Federal grant dollars of ∼$1.2 million were received the following month, and the total project cost was $4.2 million.
“We've taken a number of green steps over the past several years,” said CEO Ken Baker, “but the solar energy project was definitely the most ambitious. It's a great way to use renewable energy, help our community, and contribute to our bottom line.” NewAge partnered with California-based Borrego Solar Systems Inc. for design and installation of the system. More than 4,000 solar panels were made by SolarWorld USA of Hillsboro, OR, for the rooftop system. “We wanted to work with US-based companies and use US-made parts,” said Baker. “We're very pleased we were able to do that.”
After roof upgrades in 2010, solar panels now cover three-quarters of the rooftop on the 244,000-ft2 building located in Southampton, PA. “It's great to be able to do something so incredibly useful and green with the space on our rooftop,” Baker said. “Saving money on our electric bill is a bonus.”
Getting Noticed: Separation/purification specialist Pall Corporation (known to our industry more by its “Pall Life Sciences” incarnation) is another vendor company that has openly committed itself to a sustainable future. Its commitment to partnering with customers for environmental sustainability has earned the company a place on the Cleantech Index (www.cleantech.com/the-cleantech-index-ctius) since 2006. The company offers products and engineered process solutions intended to enable customers to improve their responsible use of natural resources and minimize their waste streams. The Cleantech Index includes 72 companies that are considered to be global leaders in clean technology products and services.
In 2010, Pall completed an initiative to reduce its own energy consumption, waste output, and carbon emissions by 10% across the board. All Pall facilities worldwide are certified to the ISO 14001 international standard for environmental management systems (see the “Management Standard” box). The company is a member of the Carbon Disclosure Project (CPD), a global initiative to inventory greenhouse gas emissions, and the US Environmental Protection Agency's Climate Leaders program, an industry– government partnership to reduce those emissions.
Eric Krasnoff, Pall's president and CEO, says, “There is no greater calling for a fluid management company than helping customers protect people, the environment, and our natural resources. Together we are implementing technologies that purify and conserve water, consume less energy, make alternative energy sources possible and practical, advance medicine, and minimize emissions and waste. Our collective efforts are enabling a greener, more sustainable future.”
Selling the Concept: Some companies are specifically marketing “green” products to their customers. Mettler Toledo, for example, focuses on solutions for “green chemistry.” A webinar on the company's website describes how Mettler Toledo's laboratory products fit into sustainable pharmaceutical manufacturing through process analytical technology (PAT) and quality by design (QbD) (3). Case studies illustrate how those concepts are mutually beneficial. And Bayer Technology Services is showing how its online analytics can help reduce operation costs and improve sustainability through efficient use of energy and raw materials in cell culture production.
Meanwhile, SAFC entered into a marketing agreement this past summer with Stellar Biotechnologies, Inc. involving the latter's good manufacturing practie (GMP)-grade high–molecular-weight keyhole limpet hemocyanin, an aquaculture-derived carrier protein with potential for conjugate vaccines. Stellar Biotechnologies is committed to environmentally sound aquaculture practices for sustainable cultivation of a renewable and long-term scalable supply of KLH and other proteins.
According to a DuPont survey, meeting sustainability challenges will require multiple strategies. Of respondents working on sustainable packaging, 65% said their efforts are focused on design for recyclability or use of recycled content, 57% are focused on weight reduction, 41% rely on renewable or biobased materials, and 25% say they are focused on compostable materials. “These results confirm that there are many pathways to improving packaging sustainability,” said William J. Harvey, president of DuPont Packaging and Industrial Polymers. “It starts with close collaboration throughout the value chain to spark innovation.”