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Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.
Energy and water waste can be improved with new technologies, and sustainability can be considered in the design of new facilities.
The energy efficiency of technologies for bio/pharmaceutical manufacturing facilities is changing quickly, and manufacturers can take advantage of these improvements for both old and new facilities, says Keith Beattie, executive director at Energy Efficiency Consultancy EECO2. Pharmaceutical Technology spoke with Beattie about trends and best practices in sustainable pharmaceutical facility design.
PharmTech: What are the key trends in sustainability in bio/pharma facility design?
Beattie (EECO2):There are several trends in equipment use and facility design that will improve efficiency and sustainability. The trend towards use of isolators for improving sterility assurance, for one, also leads to the use of lower cleanroom class background environments, which require less energy to maintain.
Single-use technology in biopharma manufacturing is being promoted as a more sustainable solution to large fixed vessels. It is reasoned that these allow smaller batches and therefore smaller facilities house them, with a subsequently lower HVAC [heating, ventilation, and air conditioning] energy demand. In addition, water use is lower because the systems are disposed of rather than washed.
Although I wouldn’t yet say it is a trend, there are some examples of companies taking a more holistic design approach, in which they consider and implement sustainability design from an early stage. Good examples include the winners of the International Society for Pharmaceutical Engineering Facility of the Year Award (ISPE FOYA) for sustainability, such as the Pfizer Consumer Health manufacturing facility in Suzhou, China, in 2018.
I know of one company that is changing their HVAC design standard to mandate design of low (40–45 °C) temperature heating coils in HVAC systems, which would enable them to use waste heat from processes. There is a lot of wasted heat in pharma plants, but often temperature is not high enough to be useful. HVAC is a good use for this heat, but only if coils are sized appropriately. Retrofitting is almost impossible. Design from day one gives you possibilities for the future-so designing flexibility in is a good thing to do.
A definite trend I have noticed over the past 18 months is that sustainability (in particular addressing climate change) is getting serious C-level attention, with many organizations making public commitments to going further to tackle this business issue, declaring aims to be carbon neutral or even carbon negative. This is significant. A range of solutions will be needed to achieve this, with increasing efficiency being a key one-simply off-setting emissions is not going to cut it with an increasingly aware stakeholder base.
PharmTech: What are the biggest areas of waste in pharmaceutical manufacturing facilities? What are some examples of best practices in tackling these areas?
Beattie (EECO2):The most surprising thing is that most facilities don’t know where their waste is, because they don’t have an effective metering and monitoring system or do not review the data that are available to them. From our experience, one of the biggest areas of waste is energy, especially consumption related to HVAC. We find many opportunities for energy savings here on almost every site we go to. For example; inefficient, faulty, or inappropriate control systems, configured for GMP compliance only, with little account of efficiency is one of the simplest things to solve. It is possible to be compliant and efficient! Another is over-processing of air: larger flow rates than necessary, over-cooling, over-dehumidifying, simultaneous heating and cooling-all preventable with no product quality impact.
Another area of waste is water. It’s generally a cheap resource, so paybacks on project initiatives to reduce water use are not often prioritized over energy savings. However, because its cheap, few manage it effectively, and there are often many low to no-cost opportunities to uncover. We often find savings opportunities in quality water systems (water for injection [WFI] and purified water), where the treatment processes make the water a more expensive resource. Opportunities include the recovery and reuse of WFI drain water or of water from reverse osmosis regeneration; often these can be used in lower grade uses such as cooling tower makeup or boiler makeup.
PharmTech: What are some best practices for refurbishing older bio/pharma manufacturing facilities for energy efficiency?
Beattie (EECO2): You should always review any space where use has changed to ensure the HVAC system particularly is not over-designed for its new use. Look for the best available technology; do your research, because technology development in energy efficiency is moving fast. Rising energy prices and falling technology costs do change efficiency project return on investment (ROI) dramatically, so an opportunity rejected for low ROI a few years ago, may now have become economic to do.
For example, HVAC fan technologies have improved enormously over the last five to 10 years. electronically commutated (brushless direct current) motors/fans, for example, can be installed in arrays (a group of fans) rather than one single fan. The array adds the benefit of redundancy, and retrofit is easier. Many older facilities have much larger fans running slowly, as the facility may have already done an air-change rate reduction. These large fans are now very inefficient, so changing to a correctly sized fan array can demonstrate great savings. In older facilities, fans are often at or past end-of-life, so the business case is good for replacement. Replacement offers benefits such as energy saving, reliability, quality improvement, and less maintenance.
PharmTech: What are some best practices for new facility design?
Beattie (EECO2):Companies should consider sustainability early in the design stage (pre-concept design) and carry it on all the way through. There is always a pressure to ‘value engineer out’ non-essential features, including sustainability features, but this is a very short-term view that is becoming increasingly unacceptable. It takes a strong company leader with a clear vision to ensure the right things are kept in.
Dynamic modeling and simulation of lifecycle cost and energy and water use is an evolving technology that helps designers make informed choices. Building information modeling (BIM) for commercial buildings, such as offices or hotels, has been around a long time, but BIM is more complex in a pharma plant. Where it has been found useful is to model the interaction of different technologies and the synergies to maximize the ‘system’ efficiency, rather than simply the efficiency or contribution of discrete technologies evaluated in isolation.
The new ISO 14644-16 (energy efficiency in cleanrooms) (1) and the soon to be published, updated ISO 14644-4 (design, construction, and startup of cleanrooms) (2) have excellent guidance on new thinking about cleanroom design. The basic philosophy behind these standards is that you should design your cleanroom with efficiency in mind and with the ability to tune it during its service life to match the real performance needed and to minimize energy.
PharmTech: Do new technologies for artificial intelligence (AI), such as predictive maintenance, help?
Beattie (EECO2):I have seen some examples of AI/machine learning in building controls to identify inefficiencies and flag these to users for action. One example I saw a few years ago was a client who was very proud of the long (170 items) list of issues to address on his control system that would improve efficiency. But he still struggled to get anything fixed; every month the same items would flag on the report. The point is that there are new technologies emerging that show promise, but there are well-established, proven technologies available today that are not being fully exploited.
Dynamic control of cleanrooms based on real-time measurement of particulate concentration and microbiological contamination to assure quality and deliver huge energy benefits is a reality now. I believe this technology will start to be adopted at scale over the next two to three years. For example, the EECO2 ICCS [Intelligent Cleanroom Control System] uses advanced predictive control to enable response to changing conditions in the cleanroom.
1. ISO, ISO14644-16 Cleanrooms and associated controlled environments-Part 16: Energy efficiency in cleanrooms and separative devices (Geneva, 2019).
2. ISO, ISO14644-4 Cleanrooms and associated controlled environments-Part 4: Design, construction and start-up (Geneva, 2001).