Life Cycle Assessment Analysis of Pharma Production Facility Part 2

Environmental Footprints of a Flexible Pharmaceutical Production Facility:  A Life Cycle Assessment Analysis Part 2

This article was published in the September/October 2016 edition of Pharmaceutical Engineering^® Magazine. Missed part 1?  Catch up now - Life Cycle Assessment Analysis of Pharma Production Facility or continue to part 3: Life Cycle Assessment Analysis of Pharma Production Facility Part 3.

Basic Assumptions and Data Sources

Process demand data, such as electrical power consumption, WFIs, or single-use bags, were collected on a per-batch basis, for all unit operations, at the 2,000-L process scale. For the 500-L and 1,000-L batch size, it is assumed that the process demand scales proportionally to the batch volume, except for the disposables and electrical power consumption. Data on electricity and consumables use at these volumes were collected independently. Furthermore, data for manufacturing of the entire process equipment, for every process scale, were also acquired from the equipment manufacturers. The building systems consumption and construction material data (e.g., electricity and water use for HVAC or the steel and piping amount) were gathered for a medium-sized facility. These are assumed to scale linearly with the facility footprint (area). Life cycle data on the used materials, resources, and technologies are based on GaBI,4 ecoinvent 3.2 databases,5 and environmental product declarations.

Limitations

The case study does not consider the direct environmental impact from construction and demolition activities at the facility site. Construction and demolition are then based on the exhaustive material takeoff for the building and all systems. Moreover, commuting of personnel to and from work, as well as maintenance activities during operation of the facility, is not considered.

Environmental Impacts

The study concentrates on the most relevant environmental impact categories. These are the climate change impact (in kg CO2-equivalents), commonly known as carbon footprint, the primary energy demand (in MJ), and blue water use (in m3). In this article only, the climate-change impact is presented. Very similar trends were observed in the other two impact categories. For calculation of the climate-change impact, the IPCC 20076 impact assessment method was applied.

Results and Discussion

Total Environmental Impact The total carbon footprint for a model facility over the entire lifetime is shown in Figure 2. It includes the total amount but also a

breakdown into each life cycle phase: construction, operation, and demolition.

The overall carbon footprint totals close to 28 kilotons of CO2-equivalents (CO2). The absolute value will however strongly depend on the facility case study (i.e., batch size, titer, batch frequency, total number of bioreactors, years of operations, etc.). For instance, for a facility configuration with a four-times-higher yearly production capacity, the overall footprint reaches 64 kilotons of CO2. In summary, one can expect that a higher facility capacity and longer lifetime lead to a higher overall carbon footprint. The resulting specific construction impact of 116 kg CO2 per m3 is similar to 46 calculated for a prefabricated industrial building of similar volume.7 The higher value could be attributed to the different building shell structure (i.e., modular vs. prefabricated) and the larger total floor and clean room wall area, apart from the difference on the scope definitions of both studies. The study for the prefabricated industrial building also reports lower specific values for the demolition (-2 instead of -43 kg/m3 for this study) as well as for the transportation (1 instead of 37 kg/m3 for this study). In both cases, the values are strongly dependent on the recycling level as well on the transportation distance (100 km by road instead of >21,000 km by road and container ship). These are expected to be much higher values for this model. The operational phase can also be compared to previous studies. In this case, the 26 kilotons of CO2 for the operational phase corresponds to 44 tons of CO2 per batch or 7 kg of CO2 per gram of product for a 3-g/L titer. These values are in the range of previous described carbon footprints for similar biopharmaceutical facilities.

For instance, in a study performed by GlaxoSmithKline (GSK)8  for a mammalian process at a clinical scale, the resulting carbon footprint benchmark is 65 tons of CO2 per batch and 59 kg of CO2 per gram of product. In another study published by GE Healthcare,9 where single-use and stainless-steel systems are compared for a mammalian process, the climate change impact can be calculated as 22 tons of CO2 per batch or 2 kg of CO2 per gram of product. The differences between all three studies strongly depend on the definition of each case study (i.e., bioreactor volume, titer, batch frequency, etc.) but also on the scope definition (e.g., systems taken into account). Overall, the order of magnitude for all three studies seems to be in agreement, GE Healthcare and GSK being at the lower and upper ends, respectively. Looking at the three life cycle phases, it is apparent that the major impacts occur during operation. This behavior can also be observed in office10 and commercial11 buildings. It is the result of the accumulated recurring impacts of activities over a long operational phase. With an average impact of approximately 1,900 tons per year and a facility lifetime of 15 years, the impact of the operational phase accounts for 94% of the total. For a longer facility lifetime, a larger proportion will be related to the operational phase. However, for a shorter facility lifetime such as 5 years, the operational phase still accounts for 83% of the impact. These values are slightly higher than the values reported for an office or commercial building where the operational phase accounts from 80%–90% of the total impact after 50 years of service time. This implies a larger impact of the operation for the biomanufacturing facility by the added energy and resources that are necessary to run a complex process in highly controlled environments. Construction amounts just for 8% of the total impact, whereas the demolition offsets the overall impact by 2%. The "negative impact" of the demolition has to be understood as credits won through the recycling of material in the demolition phase, especially metals. The impact in the construction phase is mainly related to the manufacturing of the construction materials for the building (57%) as well for the process equipment and utilities (28%). Even if the transportation of an entire facility, building modules, and equipment from Europe to China may appear controversial, it represents a very small portion of the total environmental impact (1%).

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• 4Thinkstep. GaBi Software-System and Database for Life Cycle Engineering, copyright 1992–2016 thinkstep AG. (Compilation 7.0.0.19, DB version 6.110). www.gabi-software.com.
• 5Swiss Centre for Life Cycle Inventories. ecoinvent Database (v. 3.2), 2010. www.ecoinvent.org.
• 6 United Nations. Intergovernmental Panel on Climate Change. "Climate Change 2007: The Physical Science Basis." Contribution of Working Group 1 to the Fourth Assessment Report of the Intergovernmental Panel on Climate Change, by S. Solomon, et al. Cambridge University Press, Cambridge UK and New York. https://www.ipcc.ch/publications_and_data/publications_ipcc_fourth_assessment_report_wg1_report_the_physical_science_basis.htm
• 7 Bonamente, E., and F. Cotana. "Carbon and Energy Footprints of Prefabricated Industrial Buildings: A Systematic Life Cycle Assessment Analysis." Energies 8 (2015): 12,685–12,701.
• 8 Snyder, M, and D. Etherington. "Carbon Footprint Benchmarking, Biopharmaceutical Process Carbon Modeling and Optimization." Presented at the ISPE Annual Meeting, 12–15 October 2014, Philadelphia, Pennsylvania.
• 9Flanagan, W. P. "An Environmental Life Cycle Assessment: Comparing Single-Use and Traditional Process Technologies for MAb Production." BioProcess International Special Report 13, no 11i (2015):10–16. www.bioprocessintl.com/manufacturing/single-use/toward-sustainable-engineering-practices-in-biologics-manufacturing.
• 10 Airaksinen, M., and P. Matilainen. "A Carbon Footprint of an Office Building." Energies 4 (2011): 1,197–1,210. file:///C:/Users/aloerch/Downloads/energies-04-01197.pdf.
• 11Peng, Changhai, and Xiao Wu. "Case Study of Carbon Emissions from a Building’s Life Cycle Based on BIM and Ecotect." Advances in Materials Science and Engineering 2015, article ID 954651 (2015).