When it comes to corporate sustainability, there are embracers and cautious adopters, says a recent report from MIT’s Sloan Management Review. More and more, the report says, “the world is tilting towards embracers.” Public policies, investors, and consumers alike are favoring companies who wholeheartedly go green [1].
Fortunately for pharma, most of its industry leaders are proven embracers. (See, for instance, “Pharma’s Green Evolution,” October 2009.) But as we all know, “green” and “sustainability” are vague, slippery terms. Sustainability in the business sense, according to the U.S. EPA, aims to “increase long-term shareholder and social value, while decreasing industry’s use of materials and reducing negative impacts on the environment.” The definition allows for a lot of wiggle room, so even the true embracers must answer to two simple words: prove it.
Feeling at least modest pressure to do so, many drug manufacturers are looking to green metrics for their processes, products, and facilities. Before an ever more jaundiced public, one’s green fingerprint must be established.
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Scratching the Surface
Pharma’s green metrics are developing, but still lacking, says Berkeley “Buzz” Cue, president of BWC Pharma Consulting and a founder of the American Chemical Society Green Chemistry Institute’s Pharmaceutical Roundtable. For pharma processes, for instance, says Cue, most major manufacturers are well acquainted with metrics such as process mass intensity (PMI, or kg material / kg product) and E-Factor (kg waste / kg product) to gauge the usage of solvents, reagents, water, and so on.
Still, pharma processes are environmentally taxing. “Typical E-factors or MI’s are greater than 100 with the industry best E/MI around 10,” Cue says. “That means the typical API process consumes more than 100 kg of materials to produce 1 kg of API. There is clearly room for improvement.”
And clearly, not everyone’s on the green bandwagon. As industry leaders begin to broaden and integrate their green metrics to provide more holistic information about what they do, they are the exception. “To my knowledge,” Cue continues, “smaller pharma and biopharma companies do not generally track green metrics unless the metric is required to demonstrate compliance with environmental regulations.”
And the generics industry, he adds, is largely absent in adopting green chemistry methods and subsequent metrics (an exception being Dr. Reddys, he notes). It’s a real issue when one considers that generics comprise a growing majority of patient prescriptions, he says.
Whether branded or generic, big or small, does corporate management care? Are green metrics just for geeks and idealists? “Those corporate officers who live in the C-suite for the most part are unaware that their companies are even involved in green chemistry—let alone that metrics to measure the greenness of their products and processes are being developed,” Cue says. “We are seeing more information about a company’s green chemistry activities on their websites and in corporate annual reports, but this is just beginning.”
Cue has heard tell that one major drug manufacturer may this year disclose E-factors for each of its commercial API processes. “It will be a huge positive step,” he says. “Nothing like peer pressure.” (Read here for the full interview with Cue.)
A Long Journey
It’s helpful to remember that this “sustainability” thing is a fairly new phenomenon. J&J provides an example of the time and effort needed to establish a comprehensive, working sustainability program. The company began its formalized sustainability journey in 1995 with a clear set of guiding principles, the J&J Credo, says Ann Lee-Jeffs, the company’s manager of Product Stewardship. The credo spelled out a management commitment to taking care of patients and employees, as well as the environment.
At the time, the company also began a series of five-year goals, the first aimed at pollution prevention. With those goals achieved, Next Generation Goals (NGG) were set in 2000 to target higher levels of our environmental, health and safety (EHS) accomplishments. These were expanded with Healthy Planet 2010 (HP2010), which went beyond EHS to cover sustainability areas such as transparency, biodiversity, and product stewardship, Lee-Jeffs notes. Finally, as the company’s understanding of sustainability continued to expand, Healthy Future 2015 goals—and accompanying metrics—were set to cover areas such as social responsibility and supply chain.
Such strategies and metrics are working. Last year, J&J ranked third among global companies, in all industries, in Newsweek’s annual green rankings. (GlaxoSmithKline and Novartis also placed in the top 10.) It fared particularly well in terms of its green policies and what Newsweek calls an Environmental Impact Score (EIS), comprised of more than 700 metrics, from greenhouse gas emissions to solid waste disposal.
“Our goals 15 or 20 years ago were facility-focused,” says Phil Dahlin, company veteran and current Sustainability Manager for J&J Pharma. Over time, he says, particularly as payers (such as group purchasing organizations and hospital networks in the U.S., and governments abroad) and other customers demanded more transparency, the emphasis shifted to how products themselves were impacting consumers and the broader environment. The internal metrics that J&J uses to gauge its own greenness now are vast.
It’s just the start, says Dahlin. “The whole field of metrics is still emerging,” he says, especially around the products themselves. This is despite the fact that, Dahlin says, payers are most interested in product improvements that save them money, or perhaps use less packaging or biodegrade more readily. They’re also interested in the chemicals that go into products and packaging—does packaging contain PVC or phthalates, for example. “Right now, most of the quote unquote metrics [of concern to payers and consumers] are more of the yes/no type of metrics,” he says. “Does the product have this in it, or not?”
This attitude is changing, he says, especially in the U.K., where the National Health Service is prodding drug manufacturers to provide more carbon footprint and lifecycle analysis information regarding products. The NHS “is convinced that the procurement of pharma products drives a large portion of the country’s overall footprint,” Dahlin says. “So how do we first assess the carbon impacts of healthcare, and how do we determine that low-carbon healthcare pathway? All these issues are emerging right now.”
Life Cycles
What is the carbon footprint of a given drug? What will its impact be over its entire useful life and beyond? As groups like NHS (and hopefully EPA and FDA in the U.S.) demand more, manufacturers will need to get a handle on life cycle assessment (LCA), especially what is known as environmental LCA. J&J is gaining competency in this area, Dahlin notes.
LCA is still not widely practiced in pharma, though in essence it’s the ultimate set of metrics to assess the sustainability of processes and products. “LCA is indeed the best framework so far to measure sustainability,” especially when environmental LCA is integrated with life cycle costing (LCC) and social LCA, says Conchita Jimenez-Gonzalez, director of operational sustainability at GlaxoSmithKline, often mentioned as the industry’s leader in LCA. “Unfortunately, the uptake has been hindered because this is a tool that can be very labor intensive, and there is not a good database of fine and complex chemicals used in pharma.”
Another challenge: most pharma companies do not understand the fundamentals of LCA beyond the tactical calculations, she says. Thus, they “find it difficult to communicate the outputs within the context of uncertainty, and especially find it challenging to translate a very complex context into specific learnings and guidance for development scientists and engineers.”
Jimenez-Gonzalez is also the chair of the ACS GCI Pharma Roundtable, whose member companies are working to simplify and streamline their LCA models, she adds. “One goal is to have predictive LCA measures incorporated earlier in development routes, so green chemistry and engineering concepts can be integrated early in synthesis.” (Pfizer is doing just this, as illustrated in “Leveraging Green Metrics for Route Selection and Process Optimization.”)
Mass and Energy
The shared LCA experiences of the Pharma Roundtable member companies have led the group to hone in on better understanding process materials. “If we improve material efficiency, we will improve our overall LCA profile,” says Jimenez-Gonzalez. The group has adopted process mass intensity as its flagship metric—“which keeps things simple, but not simplistic,” she says, and preliminary data show that members, collectively, are reducing PMI.
The Roundtable wants the vendor community more involved as well, and has recently released a letter to providers of lab notebooks and LIMS systems expressing a “strong desire” to have standardized calculation functionalities for PMI and other green process metrics.
Process mass intensity and other mass-oriented metrics are in vogue but, as Buzz Cue notes, they tend to overlook the energy ramifications of given processes. Johnson & Johnson has been experimenting with more energy-based process metrics—looking at input vs. output, where energy is lost, what energy might be renewable, and weighing different process options, says Sandy Yee, director of Environmental Affairs and Compliance for Pharmaceuticals, and a member of the company’s green chemistry team.
Through this “energy lens,” J&J and researchers at the University of Ghent in Belgium have looked at, for instance, crystallization versus chromatography for the separation of a compound, and whether distillation or solvent recovery is better, from an energy standpoint, for the treatment of solvent waste. They are also comparing the energy efficiencies of continuous and batch chemical reactions [2].
The sustainability metrics used in pharma today show three shortcomings, the Ghent researchers have noted (in the dissertation work of Ghent’s Geert Van Der Vorst): they often don’t take energy resource consumption into account in gauging the efficiency of drug processes; they tend to divide mass and energy inputs (i.e., kg and kJ); and study boundaries are often too narrow, ignoring “overall resource intake upstream of the production facility.”
The Ghent team leverages the concept of exergy—that energy cannot be created or destroyed, but its quality can decline as it is used and transformed. “Exergy analysis of production processes indicates how efficient resources are employed towards products and not towards waste and lost work,” they say.
“The downside of using the energy lens is you don’t take into account the toxicity of the materials and the amount of waste generated,” says Yee, “but it does give you insight on the energy consumed and the impact on the natural environment from that standpoint.”
Metrics at the Bench
Another intriguing tool is iSustain, which originated as an internal research tool for bench scientists at Sytech Corp., and was developed in collaboration with John Warner—of the Warner-Babcock Institute, and one of the creators of the 12 Principles of Green Chemistry. Sytech was using Warner’s algorithms already, and Warner encouraged that it be made available to industry at large. To that end, the tool was officially launched early in 2010, hosted by Sopheon Co.
Users can sample the tool for free on iSustain.com, or purchase individual (for $199 per year) or enterprise-level seats to use the tool. Many companies have one or two of their top chemists kicking the tires, says Amy Cannon, executive director of Beyond Benign, a nonprofit venture that helps to maintain the iSustain database.
Most bench chemists have the data they need already at hand in their lab notebook to use iSustain, says Cannon, regarding Bill of Materials and process step data, as well as other material on, for example, toxicity and biodegradability. (It can also handle flow chemistry, though Cannon says that a future goal is to make iSustain better tailored for continuous processes as well.)
Output includes 12 separate scores on a scale of 0 to 100 (for each of the green chemistry principles), that is presented as a spider graph that builds as data is entered. Drug development teams can then assess the 12 areas separately according to their priorities. A fermentation process for lactic acid, Cannon notes, fares better than a chemical route in all 12 categories but energy efficiency.
“Most sustainability metrics tools are not geared towards practicing chemists,” Cannon notes. Rather, they’re geared towards EH&S and other broader corporate departments. “This is really the first tool to use in the beginning design stage, in the first box of the product lifecycle. It’s generally been a fuzzy box for a lot of companies that are trying to do lifecycle assessments,” and ideally it would be tightly integrated into a manufacturer’s LCA program. By using iSustain in that fuzzy first box, she says, sustainability initiatives become much easier later in product development.
On the Facilities Front
Drug manufacturers first began turning green by focusing on facilities—how could pollution and energy usage be reduced? There has been plenty of low-hanging fruit, starting with HVAC, and manufacturers have looked to the U.S. Green Building Council’s LEED program (particularly for new construction) and more recently to EPA’s Energy Star program (for existing facilities) for guidance.
Like many life sciences companies, BD is in the process of formalizing and scaling up its global sustainability program and defining the metrics to support that program in the areas of product stewardship and sustainable operations. “We’ve come light years from where were five years ago,” says Paul Malinowski who, as BD’s director of Project Management & Corporate Engineering, oversees the capital infrastructure of some 60 facilities worldwide. “We got very serious about it two years ago and formally launched the Office of Global Sustainability. An important focus of that office has been on standardizing an agreed-upon set of metrics and setting targets for those metrics. While BD made a lot of progress when we announced our 2015 Sustainability Targets, it’s an ongoing, challenging process.”
BD’s strategy focuses on sustainable operations and product stewardship so that the company can decrease the environmental footprint of its operations worldwide. To ensure this progress, BD set energy, water and waste reduction targets to be reached by 2015. These targets measure environmental performance and show external stakeholders a commitment to decreasing the company’s global environmental footprint.
In the area of product stewardship, BD is addressing materials of concern in its products and incorporating environmental considerations into product and packaging design. Part of this culture shift includes encouraging employees to explore innovative solutions for managing products after they are used.
Target areas for BD’s manufacturing and administrative operations include: reducing energy consumption, increasing reliance on renewable energy, cutting water usage, and reducing hazardous waste and waste going offsite for disposal. The general framework for sustainability improvements to its facilities has come from LEED. BD aims to have all its new and existing facilities LEED certified, but what matters most, Malinowski says, is going through the process. “Although it’s not a requirement for all buildings to be certified, it’s an aspiration,” he says. “What we’re really more interested in doing is having the project teams go through the rigorous thought process that the LEED program lays out.” The certification itself, he says, “is like the ribbon at the end of the race.”
LEED’s EBOM (Existing Buildings: Operations & Maintenance) program has provided additional incentive and challenge, in that it requires more granular data than most facilities have, and thus requires capital investments in submetering—of specific building areas, rooms, and equipment. BD has begun a pilot program at one of its U.S. locations to develop procedures and policies around the EBOM requirements, taking advantage of state and federal grants. The idea is to build a foundation to roll out EBOM worldwide, Malinowski says. For instance, EBOM requires a “green cleaning” protocol, and once that’s developed locally it can be adopted globally.
BD is also drawing inspiration and best practices from EPA’s Energy Star program. It so happens that Malinowski serves as the lead industry representative on ISPE’s Sustainable Facilities Community of Practice, and ISPE itself announced a partnership with Energy Star in March. “This is a way to leverage both what the EPA and [ISPE] member companies are doing,” he says.
Energy Star’s pharma-specific Energy Performance Indicator (EPI) provides another set of metrics by which facilities can gauge their greenness and benchmark with other sites. It is an Excel-based program that relies on specific data about plant size, hours of operation, annualized energy purchases, heating and cooling degree days, and so on.
Submetering
The Energy Star Challenge, whose general mission is to improve the energy efficiency of commercial and industrial buildings by 10 percent or more—relies upon a toolkit that requires comprehensive data from manufacturers. The importance of submetering also arises in this context, said Walt Tunnessen, Energy Star national program manager, speaking at March’s Interphex show in New York. Sites seeking Energy Star designation must have more than half of their building square footage in manufacturing. If not, they must provide additional data particular to their manufacturing spaces, usually requiring additional metering and investment.
The industry does not have as much submetering in place as it should, Tunnessen said. One problem: The data that the meters provides is often not well integrated with building automation systems (BAS).
Submetering is challenging for Merck, said Chris Broome, senior engineer for Merck’s global energy team, speaking at the same event, and would like to have more in place. A significant portion of the company’s energy programs are “low cost or no cost,” and so it’s a tougher sell for programs that require significant investments. Nonetheless, Broome said, Merck has designated “energy funds” that go towards efficiency-related projects. The eventual goal for Merck, said Broome: detailed, real-time visibility about energy usage at each site.
Whether for LEED or Energy Star, most of the requisite data is readily available, Malinowski notes, and the issue is managing it. Like many, BD works with an outside energy monitoring firm to cull through utility bills and other information from sites around the world, to populate a database, and then present the information within a single dashboard. Merck outsources this function, too, Broome noted.
For most drug manufacturers, implementing a basic energy metrics program can pay huge dividends, said Tunnessen. “They’re not sexy,” he said, “but they are low-risk.”
In the Lab
Another relatively new initiative is the Labs21 project (www.labs21century.gov/), an EPA/Department of Energy joint project aimed at making all laboratories more environmentally sound. The program’s LEEP, or Laborotory Energy Efficiency Profiler, tool, helps labs to look at areas that may be easy targets for immediate improvements—ventilation, heating and cooling, and so on. Used with the Labs21 Energy Benchmarking Tool, a web-based database containing energy use information from more than 200 labs, labs can benchmark how they’re doing in terms of whole-building metrics (e.g., BTU/sf-yr) as well as system-level metrics (e.g., ventilation W/cfm).
Merck plans to take advantage of Labs21, noted Broome. Many aspects of lab work can be made more energy-efficient, he said, and projects are easier to accomplish within labs than in GMP environments.
Identify and Integrate
How does a manufacturer identify what metrics are needed throughout the organization, and prioritize them? This is where NIST, the National Institute of Standards and Technology, is lending support with its new sustainability measurement infrastructure repository (SMIR). The tool includes three components, says Shaw Feng of NIST’s manufacturing systems integration division: an indicator repository that stores information on what to measure, a set of measurement guidelines, and a specification of reporting measurement results.
“To become sustainable, a company needs to develop and implement a company-wide sustainability measurement infrastructure,” Feng says. But selecting the right indicators requires cross-disciplinary expertise, budget awareness, market understanding, and so on. Ideally, companies would have as many sustainability metrics as possible, Feng says. But practically, even experts can be overwhelmed by the scope of the task.
Sound methods for selecting companywide indicators already exist, Feng notes. Examples include the pressure-state-response method developed by the Organization of Economic Cooperation and Development, the driving force-pressure-state-impact-response developed by the EU, and the stressor-status-effect-integrality-well being (SSEIW) method for metric classification developed by Oklahoma State University’s Karen High. “The proposed hierarchy can be applied within the framework of life-cycle assessment (LCA), which provides a promising solution to "best-practice" metric identification as well as expanding the LCA applications to the sustainability field,” writes High [3].
“A company can select suitable indicators by going through the process of problem analysis, risk characterization, pressure point identification, and goal setting,” Feng says. Once that’s been done, the manufacturer can measure processes and apply valid benchmarks by which to improve.
References
1. Sustainability: The “Embracers” Seize Advantage. MIT Sloan Management Review. 2011. http://sloanreview.mit.edu./files/saleable-pdfs/52314.pdf
2. Van Der Vorst, G., Dewulf, J., et al. A Systematic Evaluation of Resource Consumption of API Production at Three Different Levels. Environ. Sci. Technol. 45 (2011), 3040-3046.
3. High, K. A new conceptual hierarchy for identifying environmental sustainability metrics. Environmental Prog. 23.4 (2004), 291-301.
