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www.biopharminternational.com Manufacturing and Facilities eBook 2023 BioPharm International ® 25 Facilities: Sustainability Wegner (CRB): As part of our energy + sustainability charrette, we tr y to prioritize categories that are dependent on cor porate com m it ments, regiona l resource priorities, and site-level constraints. These three influences may have different priorities around carbon, energy, waste, water, health and wellness, capital expenses, operating expenses, or building certifications. We've developed a matrix of energy and sustainability solutions that lists ideations and scores them, first subjectively, then followed by an objective analysis. This effort allows for the 'go/no-go' evaluation but can take longer if each solution is analyzed in greater detail. New technolog y can have challenges. Owners, designers, manufacturers, constructors, inspectors, maintenance service providers, and operators may not be familiar with a new technology, which as a result may require a ramp-up period for proper acclimation. Decarbonized heating solutions are a major challenge in biopharma. Many biopharma facilities have steam heating systems for sterilization needs, but then expand that system to users that do not require steam in order to reduce the number of systems to maintain. With decarbonization, it's most important to eliminate unnecessary heating needs and use the lowest grade heat necessary for the remaining users. A great contributor of sterilization needs come from water for injection (WFI) by means of distillation. Several worldwide monographs are removing the requirement for distillation in preference towards 'a process that is equivalent or superior'. Membrane technology is widely considered equivalent or superior and recognized by the United States Pharmacopeia since 2002 and the European Pharmacopoeia since 2017. While not accepted universally (e.g., China and subjectively India), it is rumored these countries' pharmacopoeias are not against the technology but rather behind in updating decades old standards. There are several benefits in producing ambient WFI by membrane with ozone sterilization—capital expense reduction, energy, water, and carbon savings—which saves on operating expenses. BioPharm: What about carbon offsets? Could those achieve zero-carbon? Wegner (CRB): Maybe. There is a lot of greenwashing involved with carbon offsets, and I'm a firm believer that rather than covering up a known wrong, it's better to fix it at its source. We have the technology available today and a strong momentum towards eliminating carbon emissions. Those that choose to purchase offsets are likely to trade short-term gains into greater long-term negative cost impacts. Existing facilities BioPharm: What are the challenges with achieving zero carbon at an existing operating facility? Wegner (CRB): Achieving zero carbon at an existing facility creates several challenges. Electrical Infrastructure. A typical biopharma facility consumes about half of its energy from natural gas, with the other half from electricity. While there are more efficient electrical options, there will ultimately be a net add when converting BTUs [British thermal units] to kW [kilowatts]. Existing switchgear, electrical rooms, transformers, and, in some cases, utility feeds need to be sized adequately for shifting that energy demand. This is why energy efficiency reduction measures are the most important first step in decarbonization. Shutdown. Most biopharma facilities operate 2 4/7/365 w it h m i n i m a l sc hedu led dow nt i mes. Designers will often need to have adequate space to build a new system in parallel to an existing online system so that a tie-over can be made during that downtime, and the old equipment can be demolished afterwards. BioPharm: How would ex isting operations be converted to zero carbon? Wegner (CRB): Start with a sustainability master plan or 'roadmap'. Biopharma facilities are complex, operate 24/7 with minimal shutdowns, and are subject to regulatory constraints with varying expiration of existing equipment. A proper site utility master plan (SUMP) will identify corporate commitments, regional priorities, and site- level constraints [as well as] benchmark current utility metrics, review conser vation measures, evaluate equipment lifecycle expectations, and evaluate best available technologies—all in order to provide a 'what by when' roadmap to meet those long-term goals. Clients should review their progress on a yearly basis and review their master plan on a two- to three-year cycle to ensure the best available technologies are current to make any adjustments deemed necessary. Reference 1. T he World B a n k . C a r b on P r ic i n g Da s h b oa rd . Map and Data. https://carbonpricingdashboard. worldbank.org/map_data. ■ We have the technology available today and a strong momentum towards eliminating carbon emissions. — Jeff Wegner, CRB