By: Samir Pinheiro Hernandez
It is known that the theme sustainability is in vogue and is an element of several other subjects. This is valid and true when dealing with the theme GEP – Good Engineering Practices. It is notorious that, a project whose good practices are the basis for its elaboration, must have sustainable elements. However, it can be difficult to visualize how to apply convergence of both concepts.
This article aims not only to show that the concepts of sustainability are part of the GEPs, but also to demonstrate the tools that can be used for the application of both themes.
Good Engineering Practices
In the context of pharmaceutical engineering and Good Practices (GxP) guides, GEP is often referred to in documents as a prerequisite for compliance activity but is loosely defined. GEP is often used to describe an engineering management system that is expected in a regulated company, but which is not provided for in GxP regulations, and is part of GEP.
ISPE’s GEP Guide considers the full range of pharmaceutical engineering activities and identifies key attributes of GEP within it, including how GEP relates and interacts with GxP. GEP’s scope spans the entire engineering lifecycle, from concept to non-use. GEP provides necessary foundations throughout the pharmaceutical industry, within various areas, such as GxP and construction.
Sustainability
Sustainability or sustainable development is defined as:
“Development that meets the needs of present generations without compromising the ability of future generations to meet their own needs and aspirations.” Figure 1.
Figure 1 – Defining sustainability. According to the UN, “Development that meets the needs of present generations without compromising the ability of future generations to meet their own needs and aspirations.” [2]
Sustainability and, particularly on climate change, is considered by some to be controversial. The authors of the ISPE Handbook: Sustainability based their definitions and premises on those already established and accepted by the UN-United Nations, which in turn refers to the Intergovernmental Panel on Climate Change (IPCC).
Sustainability, or rather what are considered as sustainable solutions have, until today, been accepted in practice where there are obvious commercial advantages when applied to existing systems. Many, if not most pharmaceutical industries, have accepted initiatives that provide potentially significant risk reductions, such as, where they consider it feasible, the introduction of green chemicals, reductions in air volumes and energy use provided by photovoltaic panels.
The Use of Energy in the Life Sciences Industry
The drug production process consists of several distinct stages, starting from research for pre-clinical testing, mass clinical manufacturing for the manufacture of the active substance and then for industrial formulation and filling plants. In addition, there are needs for storage areas and administrative offices, supporting the research and manufacture of medicines. These facilities and processes vary greatly in their characteristics and therefore have different energy use needs. Figure 2 shows the typical energy consumption among the different categories of consumers, such as process equipment, lighting, and air conditioning.
Figure 2: Typical energy consumption for the pharmaceutical industry. [7]
The Importance of Knowing the Use of Energy in a Plant or Building
During the conceptual phase of a new project, or retrofit of an installation, the objectives and forecasts of energy consumption and carbon emissions must be clearly identified, foreseen, and calculated. The basis of the objectives can be evaluated in the previous phase of the project, during the Master Plan Site, with reference to known and published sustainability principles. Furthermore, for existing plants, understanding how energy is used, among other things, allows the possibility of using information as a reference for other similar installations.
How and Why Compare?
Benchmarking, measure, document and report improvements in energy consumption and its effect, designed to reduce greenhouse gas emissions and energy consumption. It should be compared to industry standards where possible.
Currently, there are many tools and techniques widely applied for comparing engineering solutions that reduce the costs of operating a building. The ANSI/ASHRAE 140 – Standard Method of Test for the Evaluation of Building Energy Analysis Computer Programs standard establishes some BEM (Building Energy Modeling) software for energy simulation, such as Energy Plus, from the U.S. Department of Energy. Other software used for energy simulation is the Hourly Analyses Program (HAP®), or the Trace® 700. It is important to point out that energy simulation, however judicious as it may be, will not be a reliable prediction of the consumption of the building in operation. It will serve only as a beacon for comparison between the various technologies possible to be applied in a project during its conception phase.
Therefore, consider a design in the early phase of the project (Figure 3), in order to compare engineering solutions. More detailed modeling can be performed at the end of the project, when more consolidated information is available. In this way, key stakeholders may have initial information for decision making, thus avoiding schedule delays, and providing more accurate modeling at the end.
Figure 3 – Benefits of energy modeling at the beginning of the project. [2]
Predicting, Measuring and Achieving Performance
Comparison (or benchmarking) of similar facilities within other organizations. It is particularly useful when these other companies have facilities in the same region, with similar climate, and similar greenhouse gas emissions per unit of energy.
In addition to several other attributions, the concept of GEP also includes the competence to design and specify with special attention to the energy consumption item. Part of an engineer’s mission includes the application of GEP. Several sources of guidance, identifying key areas to be considered, or the principles that should be adopted when trying to achieve energy efficiency solutions, can be useful for the professional involved. Excellent guides and manuals can be found not only in ISPE, but also in ASHRAE and LEED however, non-normative. The ISPE Guide to Good Practices: Heating, Ventilation and Air Conditioning (HVAC) is one of these sources. It considers GEP related to environmental control systems engineering. This guide illustrates the typical configurations of HVAC systems and identifies areas where resource savings can be achieved through a project focused on low power consumption.
GEP Applied to Project and Operation
GEPs should be applied during all phases of building design. User Requirements Specifications (URS) should be developed for each system, thus defining the minimum requirements, but not how they should be achieved, i.e. not how the system should be designed. In addition, sustainability should be one of the main objectives, within the lifecycle approach, for all building facilities.
Key Performance Indicators (KPI), are management tools for measuring and the consequent level of performance and success of an organization or a given process, focusing on the “how” and indicating how well the processes of that company are, allowing its objectives to be achieved.
Within the Engineering Management process of a pharmaceutical facility, KPI is an important milestone, as suggested in the ISPE GEP Guide diagram, Figure 4. Maintenance Hists and Production Measurements continuously feed into KPI analysis. KPI analysis results may indicate improvement needs. Requests for improvements, like any other request for change, feed into the Change Management process. All changes must have their impacts evaluated, in several aspects.
Figure 4: Engineering Management Process. [1]
Evaluation, Goals and Benchmarking
For the purposes of benchmarking companies, a global organisation may use a single internationally recognised evaluation system. ASHRAE Building EQ (Figure 5), LEED v4, or BREEAM International offer models for this implementation (Figure 6). Far beyond this international application, recognition of methods by local countries, consumers and stakeholders should be considered.
Figure 5 – Labeling of a building by ASHRAE Building EQ. [12]
Figure 6 – Global distribution of the main building classification systems. [2]
Benchmarking the energy consumption of buildings
When studying how to improve a building’s energy consumption, it is critical to understand how it performs. Benchmarking can help compare the energy performance of the building with something similar, such as its performance compared to the same period last year, or performance compared to similar facilities (even buildings) in other geographic regions. There are several simple benchmarking approaches used today to help identify energy consumption.
– Energy Use Intensity (EUI) in MJ/m2.year (kBtu/sf.year)
– Energy Cost Intensity (ECI) in $/m2.year ($/sf.year)
– Resource Cost Intensity (RCI) in $/m2.year ($/sf.year)
In Table 1, we can see a comparison between several types of commercial buildings of different activities, using the EUI indicator as a reference.
Table 1 – Comparison between several types of commercial buildings of different activities, using the EUI indicator as a reference. [5]
Case Study: Installation of the Year
FOYA-Facility of the Year Award from ISPE, combines GEPs and Sustainability in its awards, celebrating good engineering practices, and sustainability. The winners in this category are models in the application of new approaches, tools, techniques aimed at improving energy efficiency, minimizing waste, reducing the carbon footprint, incorporating green manufacturing techniques, reducing environmental impact, and resulting in more efficient process systems and utilities, adding more value to the business.
In 2016, the award-winning project was from Ethicon, LLC (a subsidiary of Johnson & Johnson). With a factory in San Lorenzo (Figure 7), Puerto Rico stood out in the sustainability category. An installation of 13.700 m2 was established in 1988 as a high-tech factory for a variety of medical devices that include surgical sutures and topical skin patches. The site’s sustainability efforts resulted in a 26% (4.4 million kWh) energy reduction and a 9% (1,25 million liters) reduction in water consumption, while production volume increased by 11% compared to 2.010 levels. This project had an IRR (Internal Rate of Return) of 30%.
Some of the sustainability elements included: the optimization of the chilled water system, installation of a 600 kW photovoltaic system (Figure 7), replacement of lighting with LED lamps, The Energy Treasure Hunt program, optimization of HVAC controls and improvement of the power factor.
Figure 7 – Left: Ethicon, LLC. Right: Photovoltaic System. [8]
Final Considerations
Today, with human activities already impacting the environment, the recognition of sustainable practices as good engineering practices is notorious. It is highly recommended to apply sustainability concepts, even if the project is not interested in being certification. Benchmarking, as a good sustainable engineering practice presented here, allows these concepts to be widely applied, besides being an important tool for solving the problems we are facing. Crises, whether economic, or environmental, of which our planet already shows clear signs, are opportunities to focus on more efficient systems, consuming so scarce financial and material resources, more effectively, productively, and efficiently.
References
[1] ISPE Good Practice Guide: Good Engineering Practice; 2021.
[2] ISPE Handbook: Sustainability; 2015.
[3] 2021 ASHRAE Fundamentals Handbook – Chapter 35 – Sustainability.
[4] Sustainability in pharmaceutical manufacturing; Article from Pharmaceutical Engineering Magazine; January-February 2016.
[5] Benchmarking Building Energy Use; Article from ASHRAE Journal; November 2015.
[6] ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC); 2009.
[7] Energy saving in pharmaceutical facilities: A risk-based approach; Article from Pharmaceutical Engineering Magazine; November-December 2007.
[8] Facility of the Year Awards – https://ispe.org/facility-year-awards/winners/previous/2016/sustainability
[9] ANSI/ASHRAE/IES Standard 90.1-2019 – Energy Standard for Buildings Except Low-Rise Residential Buildings.
[10] ANSI/ASHRAE Standard 105-2021 – Standard Methods of Determining, Expressing, and Comparing Building Energy Performance and Greenhouse Gas Emissions.
[11] ANSI/ASHRAE Standard 140-2017 – Standard Method of Test for the Evaluation of Building Energy Analysis Computer Programs.
[12] Putting bEQ in Practice; Article from ASHRAE Journal; May 2014.
