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Sustainability
Tue, 13 May
Wed, 14 May
1015 – 1045
Many companies are actively implementing change programs to address sustainability, climate, and environmental programs for medicinal products. Examples include the use of recycled or PVC-free materials in packaging, recycling solvents, c changes to sterile product manufacture, reduction in PFAS use, the replacement of F-gases, and new green synthetic chemistry processes. Significant programs of change bring risks to supply of medicines when implemented without a clear overarching strategy, developed collaboratively between industry and medicines regulators. As such, industry believes that support for innovation in the implementation of change programs for medicinal products is essential to enable medicines suppliers to meet goals for product safety, access, sustainability, climate and the environmental.
This session will explore how innovation in product design and manufacturing can deliver for medicines manufacturing & explore how alternative CMC regulatory tools and approaches, based on principles of science & risk used to enable rapid access to medicines, can enable the transformation of medicines and manufacture. The session will also look at how the modernization of the variations framework and reliance enable change. The session will reference positions of ISPE, EFPIA and EMA on enabling sustainability in product design and manufacturing and use EFPIA companies examples of sustainability change programs.
This session will explore how innovation in product design and manufacturing can deliver for medicines manufacturing & explore how alternative CMC regulatory tools and approaches, based on principles of science & risk used to enable rapid access to medicines, can enable the transformation of medicines and manufacture. The session will also look at how the modernization of the variations framework and reliance enable change. The session will reference positions of ISPE, EFPIA and EMA on enabling sustainability in product design and manufacturing and use EFPIA companies examples of sustainability change programs.
1045 – 1115
Sustainability
Mirella Miettinen, PhD, University of Eastern Finland
We have systematically analyzed EU chemicals policy and legislation to detect relevant initiatives and concrete changes to chemicals legislation. We identified nearly 40 concrete changes to EU chemicals legislation that could have an impact on the pharmaceutical industry or other actors in the pharmaceutical sector. These comprise amendments to the REACH Regulation, including the proposed restriction on PFASs, amendments to the CLP Regulation, restrictions on certain substances (such as titanium dioxide), changes to EU water and industrial emissions legislation, new requirements for packaging and sustainable products, an obligation to exchange data between EU agencies, and more comprehensive sustainability reporting and due diligence requirements.
We have also examined how these changes to EU chemicals legislation are reflected in EU pharmaceutical policy and legislation and related guidance documents, as well as in position papers and other documents produced by the pharmaceutical industry, interest groups, and other stakeholders. In addition, semi-structured interviews have been conducted to explore how different actors (5 pre-defined groups) in the pharmaceutical sector perceive changes in EU chemicals policy and legislation and whether these changes may have influenced the practices and measures taken toward green transformation. The preliminary results of the interviews with the pharmaceutical industry will be presented.
We have also examined how these changes to EU chemicals legislation are reflected in EU pharmaceutical policy and legislation and related guidance documents, as well as in position papers and other documents produced by the pharmaceutical industry, interest groups, and other stakeholders. In addition, semi-structured interviews have been conducted to explore how different actors (5 pre-defined groups) in the pharmaceutical sector perceive changes in EU chemicals policy and legislation and whether these changes may have influenced the practices and measures taken toward green transformation. The preliminary results of the interviews with the pharmaceutical industry will be presented.
1115 – 1145
Sustainability
Bob Brooks, PhD, Biophorum
Victoria Mwanza, BioPhorum
Tori Crawford, BioPhorum
Navigating Regulatory and Government Body Challenges: BioPhorum's Collaborative Approach to Managing Materials of Concern
The Material of Concern Workstream, initiated by BioPhorum, addresses the regulatory and environmental challenges posed by materials of concern such as PFAS, EtO, and Triton X 100. This initiative emerged as a result of a number of industry consultations led by the European Chemicals Agency (ECHA) and the US Environmental Protection Agency (EPA), which highlighted the significant impact of proposed changes on the biopharma sector. The workstream aims to enhance understanding and management of these materials through a collaborative approach involving various teams and communicating closely with the relevant regulatory and government bodies.
The workstream is divided into two teams:
1. Reactive Team, which responds to current materials of concern, these teams have submitted a number of regulatory responses to agencies as well as collaborated with FDA, EPA, ECHA, BARDA, US centre and congress etc through a number of face-to-face or online meetings
2. The Proactive Team establishes systems to handle new potential concerns. The proactive process involves capturing material alerts, evaluating impacts, assessing industrial implications, and engaging with regulatory bodies during consultation periods. The ultimate goal is to position biopharmaceutical manufacturing as a globally recognized 'Use Case' that warrants attention from regulatory agencies.
The team ultimately wish to foster an environment where process and collaboration is in place in order to ensure that the proposed standards protect both environmental and public health without compromising the availability of critical biological products.
The Material of Concern Workstream, initiated by BioPhorum, addresses the regulatory and environmental challenges posed by materials of concern such as PFAS, EtO, and Triton X 100. This initiative emerged as a result of a number of industry consultations led by the European Chemicals Agency (ECHA) and the US Environmental Protection Agency (EPA), which highlighted the significant impact of proposed changes on the biopharma sector. The workstream aims to enhance understanding and management of these materials through a collaborative approach involving various teams and communicating closely with the relevant regulatory and government bodies.
The workstream is divided into two teams:
1. Reactive Team, which responds to current materials of concern, these teams have submitted a number of regulatory responses to agencies as well as collaborated with FDA, EPA, ECHA, BARDA, US centre and congress etc through a number of face-to-face or online meetings
2. The Proactive Team establishes systems to handle new potential concerns. The proactive process involves capturing material alerts, evaluating impacts, assessing industrial implications, and engaging with regulatory bodies during consultation periods. The ultimate goal is to position biopharmaceutical manufacturing as a globally recognized 'Use Case' that warrants attention from regulatory agencies.
The team ultimately wish to foster an environment where process and collaboration is in place in order to ensure that the proposed standards protect both environmental and public health without compromising the availability of critical biological products.
1315 – 1345
Sustainability
Pierre-Emmanuel Cau, UCB
Alessandro Rosengart, VTU Engineering
The need for increased sustainability of new and old production facilities in the pharmaceutical industry requires a holistic approach to effectively minimize carbon emissions and reduce resource consumption. Yet, it is crucial to maximize the value of capital investments while keeping operating expenditures low. Therefore, it is essential to understand the energy carriers, carbon dioxide, and other material flows within a facility. From a thorough understanding of the current status, an improvement strategy can be defined, utilizing specifically developed tools to assist decision-makers when environmental, economic, and production trade-offs occur. Based on real industrial case studies, options for heat recovery, solvent recycling, and water reuse are presented as part of a techno-economic sustainability strategy for implementation. This strategy compares the investment costs for advanced engineering solutions in operational facilities to changes in operational expenditures, electrical and thermal power use, water consumption, and carbon dioxide emissions.
This approach is being applied in the PharmECO project, a public-private partnership co-funded by the Innovative Health Initiative that is set to integrate sustainability considerations into every phase of pharmaceutical manufacturing. The industrial consortium members belong to the most influential pharmaceutical global players, ensuring a substantial impact on the footprint of the pharmaceutical industry.
This approach is being applied in the PharmECO project, a public-private partnership co-funded by the Innovative Health Initiative that is set to integrate sustainability considerations into every phase of pharmaceutical manufacturing. The industrial consortium members belong to the most influential pharmaceutical global players, ensuring a substantial impact on the footprint of the pharmaceutical industry.
1345 – 1415
Sustainability
Estelle Darnon, Technip Energies
Integration of Sustainability Objectives on Pharma Project - From Feasibility Stage Until Construction
Sustainability requirements must be followed as Quality requirements all through a project. A parallel will be done between Sustainability and Quality requirement management. This presentation will highlight some examples of integration of Sustainability objectives through technical studies: building thermal studies, multi-criteria analysis with sustainable criteria for HVAC Hot Water production solutions, energy saving by design using Water For Injection membrane production, workfront management, and digitalization during construction (reduce rework, reduce waste). This presentation aims to open discussion regarding problems encountered during recent projects on Sustainability topics.
Sustainability requirements must be followed as Quality requirements all through a project. A parallel will be done between Sustainability and Quality requirement management. This presentation will highlight some examples of integration of Sustainability objectives through technical studies: building thermal studies, multi-criteria analysis with sustainable criteria for HVAC Hot Water production solutions, energy saving by design using Water For Injection membrane production, workfront management, and digitalization during construction (reduce rework, reduce waste). This presentation aims to open discussion regarding problems encountered during recent projects on Sustainability topics.
1415 – 1445
This presentation focuses on decarbonization initiatives from a designer perspective. It defines Net Zero Carbon (NZC) and stresses the importance of Whole Life Cycle Assessment (WLCA) in evaluating the environmental impact of facilities throughout their lifecycle. Carbon-saving opportunities are explored for both operational and embodied carbon. Operationally optimizing airflows, lighting, HVAC systems, and commissioning processes are essential strategies. For embodied carbon, recommendations include reusing materials, selecting low-carbon alternatives, reducing waste through off-site fabrication, and applying modular design principles for future adaptability and disassembly. It highlights major carbon emission contributors in building services design, particularly the air change rates in cleanrooms, and shows carbon reductions can be achieved by revisiting the conservative design fundamentals that the industry has relied on in recent decades.
Case studies will demonstrate the successful implementation of NZC principles, such as reducing CO2 emissions by 37% through local material sourcing and design modifications. However, challenges remain, including policy barriers, data gaps, and the need for technological advancements and behavioral changes within the industry. The conclusion emphasizes a comprehensive design approach - LEAN, MEAN, and GREEN - along with energy modeling, early carbon-impact identification, and collaboration as critical to achieving Net Zero goals, with carbon offsetting as a last resort.
Case studies will demonstrate the successful implementation of NZC principles, such as reducing CO2 emissions by 37% through local material sourcing and design modifications. However, challenges remain, including policy barriers, data gaps, and the need for technological advancements and behavioral changes within the industry. The conclusion emphasizes a comprehensive design approach - LEAN, MEAN, and GREEN - along with energy modeling, early carbon-impact identification, and collaboration as critical to achieving Net Zero goals, with carbon offsetting as a last resort.
1530 – 1600
Sustainability
Jean-Francois Fedorenko, GlaxoSmithKline Biologicals
Emilio Moia, Jacobs Italia SpA
The manufacture of sterile products is carried out in a cleanroom, where it must maintain a cleanliness grade compliant with Annex 1. HVAC plays a key role, but on the other end, it means a significant energy cost. The aim of this presentation is to speak about the triggers that influence the HVAC design and the strategies that have been adopted in recent projects to reduce the energy cost of the HVAC, such as: definition of the Air Change based on the contamination source; design for Air Reduction Mode; progress on Adaptive Flow Control, considering the airborne control measurement system; and selection and design of an HVAC System with a low SFP (Specific Fan Power).MEAN, and GREEN - along with energy modeling, early carbon-impact identification, and collaboration as critical to achieving Net Zero goals, with carbon offsetting as a last resort.
1600 – 1630
Sustainability
Saeed Masoudi, Takeda Pharmaceuticals International AG
The pharmaceutical industry relies heavily on cleanroom environments to ensure the safety and quality of its products. Maintaining proper airflow within these cleanrooms is crucial for minimizing contamination and ensuring product integrity. This presentation aims to provide valuable insights into the most effective approach for simulating airflow in pharmaceutical cleanrooms using CFD and to provide a robust procedure on how the airflow rate should be managed in cleanrooms. An immediate result of the exercise would be a significant decrease in energy consumption of the HVAC system while maintaining regulatory requirements.
1630 – 1700
Sustainability
Eilis Kelly, J&J
Alfred Penfold, PM Group
It is not always the case that a more sustainable design can lead to many opportunities such as a reduction in operating cost and associated improvements in productivity and quality. However, the HVAC design is one such opportunity which typically represents anything from 50% to 80% of the total energy consumption of a new facility. The high percentage reflects the stringent requirements for maintaining controlled environments, including temperature, humidity, and air quality that are critical when meeting the Annex 1 requirements for the production and storage of pharmaceutical products. Europe is developing directives to improve the sustainability of facilities and products by incorporating these objectives into their regulations. Learn how to design more sustainable HVAC systems for cleanroom environments that comply with Annex 1.
1100 – 1115
Buildings account for almost 40% of global GHG emissions. This relates to emissions arising from materials of construction and operational emissions such as energy. The global transition to Net-Zero will require decarbonization changes across all elements of society, including the way we design our buildings and manufacture products. Decarbonization strategies for manufacturing facilities, both existing and new build, are essential. To achieve Net-Zero Buildings, the embodied carbon emissions associated with building construction must be reduced. Reducing operational emissions alone will not achieve Net-Zero. Regulatory authorities are recognizing this and introducing legislation for the reporting of whole-life carbon emissions associated with building construction. The revised EU Energy Performance of Buildings Directive puts all European building stock on track to be fully decarbonized by 2050. Further, the Corporate Sustainability Reporting Directive mandates organizations to report their greenhouse gas emissions publicly.
This presentation will provide insight into the source of carbon in pharmaceutical buildings with case study findings on reducing embodied carbon and facility operational carbon emissions. An overview of future regulatory requirements on life cycle assessment for carbon emissions of new buildings will be provided including the challenges & design strategy opportunities required to comply with EU Directives.
This presentation will provide insight into the source of carbon in pharmaceutical buildings with case study findings on reducing embodied carbon and facility operational carbon emissions. An overview of future regulatory requirements on life cycle assessment for carbon emissions of new buildings will be provided including the challenges & design strategy opportunities required to comply with EU Directives.
1115 – 1130
Freeze-drying is an indispensable process in the pharmaceutical and biotech industry, especially in the production of temperature-sensitive products such as biopharmaceuticals and vaccines. Recently, however, the question of sustainability has come more and more into focus, especially with regard to the refrigerants used. In our presentation, we will explain the challenges in the design and implementation of a refrigeration system that uses natural refrigerants. By showcasing an implemented design in a >10 mio. project, we will point out the advantages and pitfalls of such a refrigeration system. Specifically, we will focus on the design of the cooling unit, the choice of the installation site and the involved risk analysis, the security measures e.g. gas detection systems and automatic shut-downs, and the operation of the system.
1130 – 1145
Decarbonizing pharmaceutical sites through the use of heat pumps for heat generation involves integrating renewable energy systems to reduce carbon emissions.
1 - Methods: For greenfield sites, the installation of geothermal, water source or air-source heat pumps can be included in the project's design phase, allowing the infrastructure to maximize efficiency. Brownfield sites can be more complex and will require retrofitting heat pumps into existing systems. Key items to consider are examining closely utility load profiles and interfacing with existing systems.
2 - Design Strategies: Optimal design strategies include conducting thorough energy assessments to determine the most efficient heat pump configuration. Integration with other renewable technologies can further enhance energy efficiency. Smart energy management systems can be employed to monitor and adjust Utility heat generators in real-time, ensuring the heat pump operates at peak efficiency.
3 - Benefits: Key benefits include significant reductions in carbon emissions.
1 - Methods: For greenfield sites, the installation of geothermal, water source or air-source heat pumps can be included in the project's design phase, allowing the infrastructure to maximize efficiency. Brownfield sites can be more complex and will require retrofitting heat pumps into existing systems. Key items to consider are examining closely utility load profiles and interfacing with existing systems.
2 - Design Strategies: Optimal design strategies include conducting thorough energy assessments to determine the most efficient heat pump configuration. Integration with other renewable technologies can further enhance energy efficiency. Smart energy management systems can be employed to monitor and adjust Utility heat generators in real-time, ensuring the heat pump operates at peak efficiency.
3 - Benefits: Key benefits include significant reductions in carbon emissions.
1145 – 1200
As sustainability becomes a global priority, the Life Sciences industry faces immense pressure to deliver lifesaving medicines and medical devices faster while working toward Net Zero goals. This necessitates innovative thinking to replace traditional practices with creative production approaches, essential for future-proofing business models and driving positive industry change. Fortunately, sustainability efforts benefit from government and supranational support, as well as the push for digitalization. Digital solutions provide a strategic pathway for sustainability, focusing on energy efficiency, waste reduction, and cleaner operating models. By adopting digital tools, businesses can make granular refinements, leading to significant efficiency gains over time.
This presentation will explore the compelling business case for sustainability and demonstrate how the digital thread's "seamless flow of data and processes throughout the value chain” enables sustainability initiatives. Integrating digital technologies allows businesses to optimize energy consumption, reduce resource waste, and enhance operational efficiency. Digital technology plays a transformative role in achieving net-zero goals, enhancing operational efficiency, and driving long-term growth while minimizing environmental impact.
This presentation will explore the compelling business case for sustainability and demonstrate how the digital thread's "seamless flow of data and processes throughout the value chain” enables sustainability initiatives. Integrating digital technologies allows businesses to optimize energy consumption, reduce resource waste, and enhance operational efficiency. Digital technology plays a transformative role in achieving net-zero goals, enhancing operational efficiency, and driving long-term growth while minimizing environmental impact.
1200 – 1230
Sustainability
Michael Keohane, PM Group
Michael Keohane, PM Group
Rodrigo Alves, Rockwell Automation
Join us for an engaging session where participants will have the opportunity to ask questions about the four case studies presented. This forum is designed to foster dynamic discussions, allowing the presenters to delve deeper into the topics, share insights, and challenge perspectives in a collaborative environment.
Speaker Qualifications
Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.
Agenda Changes
Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.