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DEGREE PROJECT IN ENVIRONMENTAL ENGINEERING, SECOND CYCLE, 30 CREDITS STOCKHOLM, SWEDEN 2020
Towards sustainable project management
A life cycle approach to evaluate the biopharmaceutical industry
LOVISA OLIN
KTH ROYAL INSTITUTE OF TECHNOLOGY SCHOOL OF ARCHITECTURE AND THE BUILT ENVIRONMENT
Towards sustainable project
management
A life cycle approach to evaluate the
biopharmaceutical industry
LOVISA OLIN
Supervisor MIGUEL BRANDÃO, Assoc. Professor Examiner MONICA OLSSON, SEED director Supervisor at Octapharma MAGNUS BERGQVIST, EHS Officer
Degree Project in Sustainable Technology
KTH Royal Institute of Technology
School of Architecture and Built Environment
Department of Sustainable Development, Environmental Science and Engineering
SE-100 44 Stockholm, Sweden
II
TRITA-ABE-MBT-20629
III
Abstract
Adopting sustainability practices in both planned and current operations is increasingly important
to many organizations. Due to increased awareness various companies are adopting life cycle
thinking. For example, life cycle considerations from raw material extraction to final disposal of
products or services are requested in environmental management system standard ISO
14001:2015. Octapharma is a biopharmaceutical company producing various medical products
for the treatment of haematology, immunotherapy and critical care. The desire to incorporate
environmental life cycle thinking into investment projects led to the research question of how this
can be achieved at Octapharma in Stockholm. The objectives included a qualitative investigation
of current environmental management strategies practiced in investment projects today.
Secondly, a case study investment project was used to explore how one of the most commonly
practiced life cycle management (LCM) tools, life cycle assessment (LCA), can be applied for
the comparison of two alternative process technologies. The results showed that Octapharma
today considers environmental aspects in some investment projects, such as construction, but it
may be improved in other types of investment projects. Therefore, specific suggestions and
modifications of the project model, in relation to life cycle management literature was developed
for important checkpoints in the project management model. Lastly the case project comparative
LCA showed that one of the technologies had a significant larger environmental footprint.
Key words: life cycle management, sustainable project management, pharmaceutical industry,
environmental aspects, life cycle assessment
IV
Sammanfattning
Inkludering av ett hållbarhetsperspektiv i företags nuvarande och framtida verksamhet har fått
ökande betydelse. På grund av större medvetenhet inkluderar flera organisationer ett
livscykeltänk, dvs. utvärdering av miljöpåverkan från råvaruextraktion till avfallshantering av
både produkter och tjänster. Bland annat ISO 14001:2015, en miljöledningsstandard, har infört
krav på livscykeltänk i certifierade verksamheter. Octapharma är ett läkemedelsföretag som
tillverkar produkter inom hematologi, immunterapi och intensivvård. På grund av ett intresse för
livscykeltänk i investeringsprojekt på Octapharmas Stockholmsfabrik skapades ett behov av att
undersöka hur detta skulle kunna åstadkommas. Delmålen i detta projekt innefattar en kvalitativ
undersökning om nuvarande inkludering av miljöaspekter i investeringsprojekt med viktiga
projektintressenter i verksamheten. En kvantitativ jämförande livscykelanalys (LCA) av ett
avslutat investeringsprojekt syftade till att genomföra en LCA av två olika processteknologier.
Resultatet visar att Octapharma idag inkluderar miljöfrågor i vissa typer av projekt, framför allt
byggprojekt, men implementeringen i andra projekt kan förbättras. Fortsättningsvis resulterade
litteratursökningen och den kvalitativa undersökningen i ett antal förslag på förbättringar i
projektmodellen på punkter där miljöfrågor är extra viktiga för slutresultatet. Den jämförande
LCAn visade att den ena teknologin hade en betydligt större miljöpåverkan.
V
Acknowledgements I would like to express my gratitude towards my supervisor Magnus Bergqvist, providing contact
with people across the company and beyond. Thank you Associate Professor Miguel Brandão for
guidance on the application of LCA. And lastly, thank you Andreas for constant support and
encouragement.
Abbreviations CBA Cost-benefit analysis
DfE Design for Environment
EHS Environment Health Safety
eLCC Environmental Life Cycle Costing
fLCC Financial Life Cycle Costing
EMS Environmental management system
EPD Environmental Product Declaration
GHG Greenhouse gas
GMP Good Manufacturing Practice
GRI Global Reporting Initiative
ISO International Organisation of Standardisation
IQ Installation Qualification
LCA Life Cycle Assessment
LCC Life Cycle Costing
LCI Life Cycle Inventory analysis
LCIA Life Cycle Impact Assessment
LCM Life Cycle Management
LCT Life Cycle Thinking
OQ Operational Qualification
PM Project manager
PMI Project Management Institute
PQ Performance Qualification
PW Pure water (deionized water)
TBL Triple Bottom Line
TG Tollgate (decision point in the project model XLPM)
URS User Requirement Specification
WFI Water for Injection (Very pure water used for
sterilization)
XLPM The project management model at Octapharma
VI
List of contents
Abstract ........................................................................................................................................................ III
Sammanfattning ........................................................................................................................................... IV
Acknowledgements ....................................................................................................................................... V
Abbreviations ................................................................................................................................................ V
List of contents ............................................................................................................................................. VI
1. Introduction ............................................................................................................................................... 1
1.1 Background .......................................................................................................................................... 1 1.2 Problem description and research question………………………………………………………………………..………… 2
1.3 Limitations/delimitations .................................................................................................................... 3
2. Theoretical framework .............................................................................................................................. 4
2.1 Project management ........................................................................................................................... 4
2.2 Corporate sustainability ...................................................................................................................... 7
2.2.1 Project sustainability management .............................................................................................. 8
2.2.2 Life cycle management ............................................................................................................... 10
2.3 Life Cycle Assessment ........................................................................................................................ 11
2.3.1 Industry applications of LCA ....................................................................................................... 12
2.3.2 Inventory data in the biopharmaceutical industry ..................................................................... 13
2.3.3 Integrating insights in decision making ...................................................................................... 15
3. Methodology ........................................................................................................................................... 17
3.1 Research design ................................................................................................................................. 17
3.2 Literature review ............................................................................................................................... 17
3.3 Qualitative study ............................................................................................................................... 18
3.3.1 Qualitative data analysis ............................................................................................................ 18
3.4 Quantitative case ............................................................................................................................... 19
3.4.1 Functional unit ............................................................................................................................ 19
3.4.2 System boundaries ..................................................................................................................... 19
3.4.3 Impact category definitions ........................................................................................................ 20
3.4.4 Normalisation and weighting ..................................................................................................... 20
3.5 Validity and reliability ........................................................................................................................ 21
4. Results and analysis ................................................................................................................................. 22
4.1 Qualitative analysis ............................................................................................................................ 22
4.1.1 Integration of environmental aspects in investment projects ................................................... 22
4.1.2 Environmental policy and environmental targets ...................................................................... 23
VII
4.1.3 The XLPM project model ............................................................................................................ 23
4.1.4 Purchasing process in investment projects ................................................................................ 24
4.1.5 Interview with an environmental manager at a different pharmaceutical company ................ 24
4.1.6 Opportunities identified to improve project sustainability........................................................ 25
4.1.7 Risks identified that may hinder project sustainability .............................................................. 25
4.2 Life cycle management in XLPM ........................................................................................................ 26
4.2.1 Stakeholder management .......................................................................................................... 26
4.2.2 Project proposal and project charter ......................................................................................... 27
4.2.3 Risk assessment .......................................................................................................................... 27
4.2.4 User Requirement Specification ................................................................................................. 28
4.2.5 Environment Health Safety (EHS) risk assessment ..................................................................... 29
4.2.6 Design review ............................................................................................................................. 31
4.2.7 Purchasing .................................................................................................................................. 32
4.2.8 Final report and hand-over......................................................................................................... 32
4.3 Case study of a finalised investment project .................................................................................... 33
4.3.1 Life cycle inventory ..................................................................................................................... 34
4.3.2 Life cycle impact assessment ...................................................................................................... 38
4.3.3 Interpretation ............................................................................................................................. 41
5. Discussion ................................................................................................................................................ 43
5.1 LCM in XPLM ...................................................................................................................................... 43
5.2 Investment project LCA ..................................................................................................................... 46
5.2.1 Different project types ............................................................................................................... 47
5.3 Drivers and LCM value creation ........................................................................................................ 47
5.4 Limitations of the thesis .................................................................................................................... 49
5.5 Future work ....................................................................................................................................... 49
6. Conclusions and recommendations ........................................................................................................ 50
7. References ............................................................................................................................................... 51
Appendix I .................................................................................................................................................... 56
Appendix II ................................................................................................................................................... 56
Appendix III .................................................................................................................................................. 57
1
1. Introduction This chapter aims to present a setting for the research, a brief background, the research question,
and objectives of the thesis.
1.1 Background The sustainability performance of companies has been increasingly important during recent years
(Epstein, 2015). International policy, for example the Paris agreement and the Agenda 2030 with
17 Sustainable Development Goals (UN, 2018), are driving change, encouraging both countries
and companies to reduce their environmental impact and contribute to a socially sustainable
society. In 2014 the European Union implemented a requirement of non-financial reporting of
social and environmental performance for large companies with more than 500 employees
(European Commission, 2018). In addition, increasing awareness among customers also puts
pressure on companies’ transparency and sustainability performance. Sustainable development is
commonly defined, after the 1987 UN report Our Common Future, as “development that meets
the needs of the present without compromising the ability of future generations to meet their own
needs” (UN, 1987). Another concept is Elkington’s Triple Bottom Line (TBL) or 3Ps (People,
Planet and Profit) where sustainable development is achieved when all three systems are in
balance (Elkington, 1998).
Octapharma is a family-owned biopharmaceutical company with around 8000 employees spread
across Europe in six locations, including Stockholm. Biopharmaceutical products are
pharmaceutical substances manufactured from biological material. This includes cultivation of
cells or bacteria to produce antibodies, vaccines or immunoglobulins among others (Jozala et al.,
2016). Octapharma’s products mainly consist of biological pharmaceuticals derived from
purification of human plasma divided into three categories: haematology, immunotherapy, and
critical care. The company also has recombinant pharmaceutical production based on cell
cultivation (Octapharma, 2018). The company is one of the world’s largest producers of
pharmaceuticals for treatment of haemophilia and other coagulopathy diseases. It has been
established in Sweden since 2002 when they acquired the facilities at Kungsholmen, Stockholm
from Pharmacia. In 2018 Octapharma published its first sustainability report with data from 2017
(Octapharma, 2018).
In order to structure the sustainability work and be able to measure progress, many organisations
implement an environmental management system (EMS). The International Organization for
Standardisation (ISO) has developed the ISO 14000 series which collects several standards on
how organisations should establish and run an environmental management system. The latest
edition of the main standard, ISO 14001:2015 requires the company to adopt a life cycle
perspective to their products/processes in order to avoid shifting environmental burden from one
stage to another (ISO, 2018b). Life cycle thinking is a systems’ perspective taking into account a
range of environmental impacts from a product’s cradle to grave, often through the application of
life cycle assessment (LCA). An LCA is a comprehensive methodology that, in detail, evaluates
the environmental performance of a product or service through its life cycle.
2
The pharmaceutical industry is a line of business highly regulated by quality standards for
guaranteeing patient safety and reporting obligations towards authorities. In terms of
environmental impacts, the pharmaceutical industry is considered an energy intensive industry
(Ramasamy et al., 2015). The production of Active Pharmaceutical Ingredients (APIs) in general
requires high consumption of chemicals. Furthermore, depending on the type of API, the end-of-
life treatment of pharmaceutical substances can be harmful to ecosystems. According to IVL only
25% of pharmaceutical substances are removed in wastewater treatment facilities. An additional
25% are lowered in concentration. Some pharmaceuticals in waste water can result in increased
antibiotic resistance or be harmful to aquatic organisms (Baresel et al., 2017). For the
biopharmaceutical industry environmental impacts does not primarily lie in above mentioned
end-of-life treatment, because biological pharmaceuticals are biologically degradable. On the
other hand, the sector has a high water consumption due to the necessity to clean the process
tanks and/or has a high consumption of sterilized single-use products resulting in large amounts
of solid waste.
Environmental sustainability in the pharmaceutical industry has been practiced since the 90s with
special focus on green chemistry in processes design (Kralisch et al., 2015). LCAs have, for
example, been applied to compare the environmental impact of different Active Pharmaceutical
Ingredients (APIs) during formulation and research (Jiménez-González & Overcash, 2014). Other
studies have focused on comparison of traditional processing and single-use technology and
different types of cell cultivation processing (Pietrzykowski et al., 2014; Bunnak et al., 2016).
LCAs are generally used as either a tool for identification of “hotspots” with large environmental
impact through the value chain, or as above mentioned, compare different synthesis pathways or
technologies. The challenges are to access life cycle data in order to produce accurate life cycle
assessments. According to De Soete et al., (2017) the pharmaceutical industry is characterized by
confidentiality, and the willingness to share data between companies in the value chain is low.
Increased transparency among companies therefore needs to be addressed.
1.2 Problem description and research question As part of retaining and developing their market position, Octapharma pursues various
investment projects in both current operations and for planned expansion. Octapharma is curious
on how to further address and reduce environmental impacts by incorporating life cycle thinking
into their investment projects. Therefore, Octapharma seeks an investigation of how life cycle
thinking can be incorporated in current project management practices. Including an
environmental sustainability assessment in investment projects may be increasingly important in
order to meet Octapharma’s sustainability ambitions. One important factor is to examine the
value of addressing life cycle impacts in projects. Other drivers are recent trends, such as
companies taking the entire value chain perspective in sustainability reporting and competitors’
environmental initiatives. There is also an interest for Octapharma in a future certification of ISO
14001, and as mentioned in section 1.1 life cycle thinking therefore is required. In terms of this
master thesis project it will only address the environmental aspects of sustainability.
3
The field of project sustainability management, however, is still an emerging field (Marcelino-
Sádaba et al., 2015). Various researchers present different strategies and models. One path is to
utilize sustainability indicators and checklists (Labuschagne & Brent, 2005; Marcelino-Sádaba et
al., 2015). Other researchers try to combine different tools such as Life Cycle Assessment and
Life Cycle Costing (Azapagic & Clift, 1999), yet others integrate Multicriteria Decision Analysis
(Kralisch et al., 2015). There is also a lack of applied examples within the industry, probably
because the research area naturally aims to propose organisational internal methods and models
which rarely is communicated to the public community. However, this thesis aims to contribute
to the applied research by combining the academic scientific papers with the company internal
project model and project stakeholder interviews. This thesis aims to answer the question:
How can a life cycle approach help improve the environmental performance and be integrated
into current practices of the project management model and create value for the company?
Value creating is defined as tangible costs/benefits and intangible costs/benefits. Tangible values
include cost-efficiency, prevention of unforeseen costs or waste reduction. Intangible costs or
benefits are more difficult to monetize. Examples includes improved legal and regulatory
compliance, increased employee and customer satisfaction and marketing opportunities.
Objectives
1. Investigate current practices of project management and identify strengths and
weaknesses in terms of integrating environmental sustainability.
2. Identify decision points and responsibilities for when environmental performance should
be analysed in the project model.
3. Identify relevant tools that can support technical investment projects in creating value in
terms of the above mentioned.
4. Apply LCA to a case investment project.
1.3 Limitations/delimitations Many different types of investment projects are conducted at Octapharma. These include
construction projects, both industrial buildings and offices, general improvement projects and
investment projects in new equipment, in either a new or existing production line. Different
project types will be briefly discussed with a main focus on projects investing in new
manufacturing equipment.
4
2. Theoretical framework This section describes the theoretical background of project management, current research on
how to incorporate sustainability in project management and common environmental
management practices.
2.1 Project management Project management, as a way of organising work, is to a wide extent used in companies across
all sectors. The idea of a project is to achieve a specified goal within a specified time frame and
resources by setting up a temporary project organisation led by a project manager. According to
Project Management Institute (PMI, 2018) it is “a temporary endeavour undertaken to create a
unique product, service or result”. Another definition is:
“a project can be considered to be the achievement of a specific objective, which involves a series of
activities and tasks which consume resources. It has to be completed within a set specification, having
definite start and end dates” (Munns and Bjeirmi, 1996).
Project management therefore is the practice of applying tools, knowledge and skills in order to
reach the specified goals. However, it has been demonstrated that successful project management
does not align with project success. Munns & Bjeirmi, )1996) suggest that successful project
management is a short-term goal, while the project itself has a long-term and wider definition of
success. They also claim that total project success is more dependent on screening out potentially
unsuccessful projects and selecting the right project from the start, rather than successful project
management (Munns & Bjeirmi, 1996).
PMBOK Guide is a standard distributed by the Project Management Institute presenting the
gathered project management knowledge and is one of the world’s most used standards (Project
Management Institute, 2017). They present the project process and key factors for success which
is guided by a project model. A project model defines what shall be done, when it should be
done, and by whom. At Octapharma, the project model is based on Excellence in Project
Management (XLPM), a model developed by SEMCON (Semcon, 2016) (see Figure 1). It is a
Figure 1. The project management model at Octapharma (Semcon, 2016)
5
widely used model that follows the standard of Project Management Institute.
Figure 2. Eleven knowledge areas in XLPM (Semcon, 2016)
XLPM is based on eleven knowledge areas under which all project activities are to be planned
(see Figure 2). The knowledge areas permeate each project phase and tasks to complete. In
addition, there is a Human and a Business perspective in XLPM to acknowledge the business
opportunities of project management but also the social and team effort in generating project
success. The model is split into different phases and tollgates. Tollgates (TG) are the decision
points where the project management group and the steering group meet, and the steering group
decides whether to proceed with the project or not. Milestones (MS) are support steps for the
project manager when controlling the project.
TG0 Decision to start project analysis
The purpose of the analysis phase is to evaluate a project proposal in terms of financial, technical
and operational viability.
TG1 Decision for start of project planning phase.
The planning phase includes identification and definition of the optimum project solution and
strategies for successful project execution.
TG2 Decision to establish the project and start project execution
Establishing the project team and executing the project according to the project plan.
TG3 Decision to continue execution according to original or revised plan
The realization is the continuation of establishment phase, managing the project performance in
order to meet the specified project goal.
TG4 Decision to hand over project outcome
Start of project closure and hand-over of the project to the receiver
TG5 Decision to start project conclusion
The project conclusion phase is where the project is finalized and approved by the receiver.
Good Manufacturing Practice (GMP) is the main regulatory framework that depicts the rules on
how to produce pharmaceuticals. All investment projects concerning, for example investing in
equipment for manufacturing of pharmaceuticals, are thus required to comply with GMP. As a
consequence, in parallel to project execution, validation activities are pursued. IQ OQ PQ
6
(Installation Qualification, Operational Qualification, and Performance Qualification) are three
independent validation procedures to test that a mechanical or software system meets its design
requirements and how it operates under load. These procedures are time consuming but necessary
processes in the pharmaceutical industry (Wellspring Pharma, 2014).
Apart from the role of the project manager, a project model involves multiple roles. A project
owner or sponsor is the role of identifying a need for change in the organisation and initiate a
project. The sponsor is also responsible for appointing a steering group. The project steering
group or reference group are responsible for taking the decision to proceed, change or
discontinue the project at the different tollgates (TG). They are assuring that the project is aligned
with the project’s sponsor proposal and the company’s business strategy, and thus they have a
supporting role to the project manager and the remaining project group members. The resource
owner is responsible for providing the project with sufficient resources, both in terms of human
resources, but also, equipment or tools and other supporting activities. The resource owner can
also be a member of the steering group. The project receiver is the role of receiving the finalised
project result, usually a manager in a unit within the line organisation. The project receiver works
closely with the manager to set up a requirement specification and enable smooth hand-over from
the temporary project organisation to the line organisation for the particular project. Several
projects can be collected in a portfolio, while programs are even larger and consists of long-term
strategic plans such as expansions of a factory and likewise. An assignment is a smaller project,
with less monetary expenses and resources.
Projects in terms of capital investment projects are truly impacting a company’s future in terms of
profitability, productivity and future competitiveness. For evaluation of financial risks, methods
such as discounted cash flow analysis is often used (Epstein et al., 2014, p.97). Cost-Benefit
Analysis (CBA) is a widely implemented management tool to examine the advantage and
disadvantages of financially choosing an alternative before another option or initiating the project
at all. However, environmental (or other sustainability) risks, costs and benefits are rarely
evaluated, due to the difficulty of assessing them. Costs related to environmental impacts include
more than direct investment costs. In order to identify the full costs various costing systems can
be used, including Life Cycle Costing (LCC), which helps identifying the full costs related to a
product or service life cycle. Decision-making in project management can be either to choose
among different projects or portfolios but also within one selected project to choose the best
solution (Epstein et al., 2014).
According to PMI value creation in project management is the essential purpose of investment
projects and project management. According to Phillipy (2014) in one of PMIs many conference
papers “Business value is the net benefit that will be realized by the customer of a project and can
be measured in either monetary or non-monetary terms”. He points out that companies that do not
fulfil customer requirements and develop through innovation, will see itself passed by other
companies that can fulfil the needs and thus obtain a larger market share. As a conclusion,
7
companies must always prioritize how to add value for customers, or it will fail and “projects,
therefore, become the lifeline of a viable business”.
Looking at “Value” as of one of eleven knowledge areas in the XLPM model it is described in
the traditional project management way as Value = Benefit/Cost. The model also describes that
defining what value mean is a joint effort of all stakeholders in a project, which means that
stakeholder analysis is key in the project analysis phase. Factors that impact project value are
different in various types of projects according to XLPM. For internal projects, (which is the
main focus of this thesis) expected ROI, competence development and employee satisfaction,
testing and deployment of new techniques or working methods are to be considered when both
planning and measuring value. As a conclusion, the XLPM model emphasize that successful
value management is relying on the ability of the project stakeholders to understand the long-
term effects of the project outcome.
2.2 Corporate sustainability Incorporation of sustainability in organisations has been widely implemented in recent years.
Corporate Social Responsibility has traditionally considered the production processes and
focused on cleaner production and pollution prevention measures. However, many organizations
have started to practice sustainability beyond the organizational boundaries developing a holistic
perspective of life cycle thinking meaning that a product’s or service’s entire life cycle of
environmental or/and social impacts are considered. It is possible that it is a response to the latest
environmental management standard ISO 14001:2015 requiring organisations to map the life
cycles of their products and services and to identify what parts of the life cycle that the company
has influence over. The concept of cradle to grave evolved around the entire life cycle showed in
Figure 3.
Figure 3. The life cycle of a product (adapted from Curran, 2015)
The business case for sustainability is long according to Epstein et al., (2014) and it includes, but
is not limited to, financial payoffs such as reduced costs, customer-related payoffs such as
product innovation, operational payoffs such as productivity gains and organizational payoffs
such as employee satisfaction. Value creation and differentiation are keys for companies, thus
sustainability initiatives connection to business value needs to be emphasized. According to
Baitz, (2015), value derives from four main categories:
8
• In sales over increasing market share or new market entry by quantifying benefits of
business to business (B2B) or business to customers (B2C) or by promoting innovation
and new products based on solid facts.
• Through cost reduction due to increase of value chain and operational efficiency as well
as employee productivity.
• Risk mitigation like operational risk management or regulatory management which
supports business continuity.
• The brand value is increased due to reputation as well as employee attraction and
retention, which lowers new employee hiring costs.
Harbi et al., (2015) states that the relationship between good financial performance and
sustainability is well recognized. Furthermore, it is suggested that value needs to be measurable
and measured in order to be acknowledged and communicated in the organisation. Value can be
created through a couple of key areas.
• Risk management
• Return on capital
• Growth
It is essential to link sustainability initiatives to those key areas of value creation. But it is also
important to already before implementation question what value creation opportunities a
project/initiative could generate. Worth noting is that sustainability as a concept on its own may
not necessarily generate value unless it is incorporated in the core business strategy (Harbi et al.,
2015).
2.2.1 Project sustainability management As sustainability practices have been developed in many large companies, project management
remains a field which lacks integration of sustainability in general. Most major project
management standards and frameworks (for example PMI and ISO 21500:2012) do not address
environmental or social issues at all (Marcelino-Sádaba et al., 2015). Amini and Bienstock (2014)
suggests multiple reasons for why project management is a good way of incorporating
sustainability in companies. The company project portfolio’s purpose is to realise the strategic
plan; thus, project management is the premier tool to incorporate a corporation’s strategic vision
and objectives. Project management is one of the most used management tools both in innovation
and in business management. This highlights the importance of project management in
incorporating sustainability in organisations. It has been stated by Amini and Bienstock, (2014)
that innovation is driving sustainability initiatives, while sustainability initiatives also push
innovation. In conclusion, project management can bridge the gap between the business strategy
and sustainability initiatives.
9
Figure 4. The interrelationship between project, asset and product life cycle, adapted from Labuschagne & Brent (2005).
Labuschagne & Brent, (2005) some of the first to research project sustainability management,
identified the interaction between the project, the asset and the product life cycle (see Figure 4).
The goal of the project life cycle, as explained in Figure 1, is to implement an asset. The asset life
cycle could be, in terms of the pharmaceutical industry, a new manufacturing equipment, or a
production line. The objective of the asset is to contribute to the manufacturing of a medicinal
product, which in turn also has a life cycle (the product life cycle). The environmental, social and
economic impacts mainly derive from the life cycles of the asset and product (Labuschagne &
Brent, 2005). Nilsson-Lindén et al., (2014) point out that internal environmental management
systems’ activities risk optimizing one part of the product chain and thus result in shifting the
burden to another stage. They therefore argue that a holistic perspective is required to consider
the complete product life cycle in order to avoid sub optimization. Moreover, Labuschagne &
Brent, (2005) studied how to practically assess the sustainability of industries. They argue that
sustainability assessments of projects are dependent on the information available at the time. In
the beginning there might be lack of detailed information, that can be available later on, but also
that the preferences of the decision-makers play an important role.
Marcelino-Sádaba et al. (2015) present a thorough review of contemporary research in project
sustainability management. They claim that corporate sustainability in project management
mainly has been characterized by ISO standards such as ISO 14062 for sustainable product
development, ISO 14040 for life cycle assessment and ISO 14006 guidelines for incorporating
eco design (ISO, 2018a). Eco-design or Design for Environment (DfE) is a widely used approach
in order to include the environmental aspects of sustainability into the product and asset life cycle
in project management. In reality, between 80 to 90% of a product’s environmental and economic
impacts are determined at the design stage (Marcelino-Sádaba et al., 2015). Bovea & Pérez-Belis,
(2012) present a thorough review of eco design tools. They suggest that the most important factor
of an eco-design tool is early integration of environmental aspects into the product design and
development process, a life cycle approach and also a multi-criteria approach that takes
traditional criteria into consideration too. They classify qualitative, semi-quantitative and
10
quantitative methods and concludes that the final choice of the tool depends on the preference of
the company.
2.2.2 Life cycle management Including a holistic life cycle perspective, as suggested by several scientific papers, leads to life
cycle management (LCM), which is the application of life cycle thinking throughout the product
chains (Nilsson-Lindén et al., 2014), i.e. making life cycle thinking operational. Life cycle
management aims to be incorporated at every level at the company in order to enhance the
performance from cradle to grave. Life cycle management make use of management practices
such as:
• Stakeholder management
• Sustainable procurement and supply chain management
• Communication management
• Environmental management systems
• Design for Environment, certification and eco-labelling
Practically it requires information through data collection and modelling in various tools. Below,
a few examples of the most important ones are listed.
• Life Cycle Assessment
• Material Flow Analysis
• Life Cycle Costing
• Cost Benefit Analysis
• Risk Assessment
Nilsson-Lindén et al. (2014) provide one of few long-term case studies of how to practically
incorporate LCM into a multinational company, focusing on the organisational management
rather than specific tools. The study concludes several important aspects. First, sustainability
should be integrated into the organisation and not be considered as “side” activity. Therefore, top
management support was considered very important, thus accessing resources to sustainability.
The study further revealed that integration of LCM into existing internal processes and tools was
a first-hand choice, such as Design for Environment principles were incorporated in the product
development. Sustainability should be horizontally integrated in all divisions/units, including
sales and purchasing. In fact, purchasers were identified as key to LCM success as they are
providing contact with upstream product chain. Furthermore, alignment with the business
strategy and creation of measurable targets translate the company strategy into operational goals
that can be followed-up and evaluated (Nilsson-Lindén et al., 2014). Similar to financial Key
Performance Indices, sustainability targets can be measured with Sustainability/Environmental
Performance Indicators (EPIs) and reported both internally and externally in the annual
sustainability report (Epstein et al., 2014).
11
Hallstedt et al. (2013) reached a similar conclusion on how to manage more environmentally
friendly product development projects:
1) Ensure organizational support from senior management;
2) Efficiently bring in a sustainability perspective early in the product innovation processes;
3) Utilize knowledge and experience of procurement staff in the earliest phases of the process;
4) Include social aspects across the product life cycle and its value chain;
5) Assign responsibility for sustainability implementation in the product innovation process;
6) Have a systematic way for knowledge sharing and competence building in the sustainability
field to inform decisions taken in future product development projects;
7) Utilize tools for guiding decisions as a complement for assessment tools;
8) Utilize tools that incorporate a back-casting perspective from a definition of success.
2.3 Life Cycle Assessment Project sustainability management and life cycle management literature suggests that one of the
key tools in implementing LCM is the use of LCA. As previously mentioned LCA is a
comprehensive tool that in detail examines and presents the environmental performance of a
product or service through its life-time and is standardised according to ISO 14040:2006 and ISO
14044:2006 (ISO, 2018a). LCAs are utilized both in public and private sector. In the private
sector LCA is applied for various reasons. Curran (2015, p. 22) suggests the following situations:
▪ establishing baseline information for a process. The baseline information is valuable for
initiating improvement analysis by applying specific changes to the baseline system;
▪ identifying possible opportunities for improvement across the product
life cycle;
▪ comparing alternative manufacturing processes or supply chains to identify
potential trade-offs;
▪ determining the environmental preferability between alternative product
choices.
▪ improving products through continuous improvement set often with concrete
reduction targets
Even though LCA is a useful tool in identification of trade-offs and aid decision-making, it has
limited applicability in that it can only help to evaluate the data that are available at the time, it is
not predictive in its nature. Environmental aspects that are assessed in an LCA include energy
use, transportation mode and distance. Thereafter, environmental waste aspects such as
atmospheric emissions, waterborne wastes and generation of solid wastes are accounted for.
Furthermore, an evaluation of waste management is conducted. Is the product sent to landfilling,
incinerated, could it be recycled or composted?
12
An LCA starts with the goal and scope definition (see Figure 5). It can have different scopes
defining the system boundaries of the study: cradle-to-grave, cradle-to-gate or gate-to-gate (use
phase only). Then, the inventory analysis phase follows in which data is collected. The life cycle
impact assessment step thereafter converts the inventory data into environmental impacts. Lastly,
the interpretation step aims to contribute to more informed decisions. It is an highly iterative
process (Curran, 2015).
Primary data from raw material extraction, manufacturing and production is favoured but if not
available, secondary data can be derived from literature or LCA databases. Computer modelling
software are often used. The most well-known softwares are SimaPro and GaBi, which both have
integrated life cycle databases. One example is
EcoInvent which supports the practitioner with
data from both upstream and downstream
processes. Several impact assessment methods are
available such as ReCiPe and ILCD which both
provide holistic impacts across numerous impact
categories. Other impact assessment methods are
so-called single-issue impact, calculating water
footprint or energy demand (PRé, 2018).
A stand-alone LCA can provide baseline data and
identify hotspots of environmental burden
throughout a product’s life cycle. A comparative
LCA compares two different products that are
providing similar functions. In general, there are
two different approaches on how to conduct an LCA. An attributional LCA is describing a
system as it is and is based on average data of environmental burden from total production
volume of for example steel. The consequential approach on the other hand is change-oriented
and determines the consequences if demand and supply of a product changes when alternative A
is chosen over B. Marginal data is used, representing environmental burdens when production
volumes change (Brandão et al., 2017).
A full LCA is data intensive and requires experience to be conducted properly. In order to
simplify the process various tools have been proposed. A screening LCA is more of a qualitative
approach, such as the LCA matrix suggested by (Graedel & Howard-Grenville, 2005). A
streamlined LCA on the other hand can focus on one environmental aspect, such as carbon
footprint and uses secondary data to generate results quickly.
2.3.1 Industry applications of LCA The Encyclopedia of sustainable technologies (Abraham, 2017) offers a full perspective on
LCAs, especially when it comes to industry applications. A large corporation in the technology
sector explained their application of LCA and life cycle thinking (LCT). The company reasons
Figure 5. Life cycle assessment framework (Ouellet-Plamondon and Habert, 2015)
13
that in sustainable product development LCA must be applied strategically and selectively to
ensure maximum benefit, due to its large data requirement. In many cases, a screening version is
used to identify those cases that need more detailed quantification. A corporate sustainability
group is responsible for developing tools and execute detailed LCAs. Screening and qualitative
methods are aimed to be used by non-experts, while streamlined quantitative tool versions require
expert support. When a full LCA is needed, several criteria can support the decision for further
analysis (see Figure 6). The results of either level of LCA is used as one of the criteria in
decision-making together with cost, risk assessment, reliability etc. According to the company,
the LCT approach is creating value through among others better products, better line of sight to
environmental issues and opportunities and better positioning with respect to regulatory trends
(Fisher & Flanagan, 2017).
Figure 6. Criteria for when to conduct a full LCA (Fisher & Flanagan, 2017).
In the pharmaceutical industry LCT/LCA has supported the green chemistry development.
American Chemical Association (ACS) GCI Pharmaceutical round table defined Process Mass
Intensity (PMI) as the total mass of materials per unit mass of product, a benchmarking tool for
the green pharmaceutical production. Other benchmarking tools are E-factor, total waste per
product and Cumulative Energy Demand which translates to the energy intensity of a product
(Ott et al., 2014). In comparison to all of the above, an LCA is much more comprehensive, as it
evaluates more than one impact category.
2.3.2 Inventory data in the biopharmaceutical industry Following the increased interest in LCAs in the pharmaceutical industry (Jiménez-González &
Overcash, 2014) address challenges of LCA application regarding specifically obtaining
inventory data. Strategies for obtaining data for life cycle assessments in the pharmaceutical
industry primarily include LCA software and LCA databases such as EcoInvent. Jiménez-
González and Overcash, (2014) point out though that many chemical substances lacks proper life
14
cycle data. In addition, there are no databases specific to the biopharmaceutical industry. The
second strategy covers engineering-based assessment or design-based assessments that are
analysing each unit process (process machine) from a gate-to-gate perspective to gather a
collection of inventory data. It is a time-consuming methodology, but it gains good insight to the
process and impacts as it generates detailed data. This data is valuable for the development of a
corporate life cycle inventory database for in-house screening tools which can be used in
investment projects. Today, there are some screening tools available for the pharmaceutical
industry, such as FLASC™ software tool developed by GSK for synthetic chemical processes
(Kralisch et al., 2015). In the biopharmaceutical industry software for calculation of process
economics and time-to-market have been used for a long time, such as Biosolve (Biopharm, n.d.)
and AspenTech (Aspen Tech, n.d.). These kinds of established tools are in many companies an
integrated part of designing unit processes and manufacturing lines meaning that a lot of
inventory data can be extracted from them. According to the latest update of Biosolve it includes
a new feature of Bill of Materials list, which is valuable from an LCA data perspective as well as
supply chain perspective (Biopharm, n.d.).
LCAs for assessment of environmental impacts have only been conducted publicly by a handful
researchers in the biopharmaceutical industry. Environmental aspects to consider include Clean-
In-Place (CIP) and Steam-In-Place (SIP) and chemicals for cleaning and sterilizing process tanks
in between pharmaceutical batches. In the 2010s single-use systems with disposable bioreactors,
tubing, mixers and chromatography columns became more frequently used technologies, thus
solid waste is another environmental aspect. Life cycle inventory (LCI) data necessary for
biopharmaceutical manufacturing processes typically consist of data on equipment/consumables
fabrication, media/buffers preparation, Water for Injection/ Pure Water (WFI/PW) production
(see 4.3.1), equipment utilisation, waste management and recycling of equipment at the end-of-
life phase (Ramasamy et al., 2015). Ramasamy et al., (2015) suggest different scopes for LCAs
and issues to explore further.
• single-use system vs conventional process tanks with CIP and SIP
• evaluating the environmental impacts of different manufacturing processing strategies
such as batch and continuous.
• assessing the environmental impacts produced by different solid waste disposal options
identifying the manufacturing process and the solid waste disposal option with the lowest
environmental impact;
• identifying the environmental “hot spots” of a given manufacturing process.
Single unit operation equipment have been quantified in previous studies. In one of the first
published LCAs GE Healthcare quantified the life cycle of a single-use bioreactor (Mauter,
2009), while Millipore examined a buffer-media filtration (BMF) system (Jobin & Krishnan,
2012). Furthermore, two complete manufacturing lines consisting of single use-technology and
conventional processing including 14 unit operations were compared by Pietrzykowski et al.,
(2013). For Inventory data Biosolve software and AspenPlus software were used along with
15
industry data from GE Healthcare and background data from EcoInvent LCA database. The study
concludes that single use bioreactors exhibit a lower impact within each category in ReCiPe
endpoint assessment method, mostly due to that SIP and CIP activities require large quantities of
water and energy. Another study compared cell cultivation based on a fed batch-system or per-
fusion based system by simulating a manufacturing line (Bunnak et al., 2016). In this study the
functional unit was based on a prospective examination of market share of a new pharmaceutical.
For life cycle inventory Biosolve software was also used to model a new manufacturing line in
combination with LCA software GaBi.
For LCA studies, the system boundaries of each assessment carefully frame the study and
indicate what data that is necessary to collect. Ramasamy et al., (2015) suggests a general LCA
framework for biopharmaceutical industries (see Figure 7). These boundaries are applicable to
projects designing a production line or investigating production footprint, thus larger investment
project. The system boundaries for each investment project must be individually selected based
on the purpose and aim of the project. Investment project system boundaries for individual unit
operation within a production line will be the focus of the next chapter in which an LCA will be
applied to a case study investment project.
Figure 7. Different system boundaries for a biopharmaceutical industry LCA (Ramasamy et al., 2015).
2.3.3 Integrating insights in decision making Integration of LCA insights to decision making includes numerous examples such as case studies
of different chemical routes to obtain API, sub-system process assessments, complete product
LCAs or enterprise environmental footprint. LCAs also support the development of screening
tools that may focus on one impact only, for ex. carbon footprint. A quick screening result
however is “trading resolution and holistic view against the ability to incorporate LCA insights
into industrial decision-making, which is a calculated and practical trade-off” (Jiménez-González
16
& Overcash, 2014). Using a screening version of LCA may therefore not be applicable to all
projects and scenarios according to (Jiménez-González & Overcash, 2014).
LCAs are mathematical models that are based on both collected data and assumptions. The
results need to be followed by uncertainty analysis such as Monte Carlo analysis, a feature of
SimaPro LCA software. Uncertainty analysis is performed in order to describe the range of
possible outcomes given a set of inputs (where each input has some uncertainty). In addition,
sensitivity analysis is testing the robustness of the final results to individual parameters in the
modelling and assess their impact on the final result (Jiménez-González and Overcash, 2014).
17
3. Methodology This chapter presents the methodological approaches used in order to answer the research
questions.
3.1 Research design The study aims to answer the question How can a life cycle approach help improve the
environmental performance and be integrated into current practices of the project management
model and create value for the company? The context is a pharmaceutical company, which
means that the result might primarily be relevant for the actual company or companies in the
same business area, but also to companies in other business areas using the project management
model XLPM. A mixed research approach is relevant in order meet the objectives, see Figure 8.
Figure 8. Theoretical framework of the research design
The method consists of two parts. First, exploring and evaluation of the current situation, by
reviewing the environmental management system and project model, but also looking at finalised
projects and project documents. Furthermore, interviews with project stakeholders aim to give a
deeper understanding of the current situation and of when and how sustainability could be
incorporated into the specific project management model at Octapharma. Altogether, risks and
opportunities of current operations were analysed in order to suggest improvements and give
recommendations. Secondly, a case study gave deeper knowledge of the project management
process and a quantitative basis for an environmental assessment. The case study was based on
the recognized life cycle assessment methodology by ISO 14040:2006 (ISO, 2018a).
3.2 Literature review Established literature is an essential component of any research process. It is a source of in-depth
knowledge, and it also provides opportunity to review and assess the quality of others’ work. The
literature review is an argumentative text, aiming to identify past and ongoing research within the
field of your proposed research question. According to O’Leary (2017), the purpose of a
literature review is to (1) inform the readers of developments in the field, (2) establish researcher
credibility, (3) argue the need and relevance for your proposed study.
In order to find relevant literature, web-based search engines were used first-hand. In the
beginning, the Royal Institute of Technology library search engine Primo was used as source of
information. Due to restrictions in the depth of the result, Google Scholar and primarily Scopus
were used as well. Key words: “project management”, “sustainable/sustainability project
management”, “LCA” “LCC”, “LCA/LCI”, “life cycle thinking project management”, “green
project management”, “environmental performance biopharma*”, “pharmaceutical LCA”,” life
cycle management”, “value life cycle management”.
Problem formulation
Literature studyQualitative
findings
Case study and quantitative
analysis
A way forward to environmental sustainability in
projects
18
3.3 Qualitative study In order to further answer objectives 1 and 2 of the current situation analysis, decision gates and
responsibilities, a qualitative approach was chosen. The aim was to get a deeper understanding of
objectives 1 and 2, and the people working according to the project model, connecting the
document analysis to “field” knowledge. Interviewing is the “art” of both asking and listening
and interviewing is a great method to collect data of peoples’ opinions, experiences and ideas. A
qualitative study is, rather than a quantitative study, requiring more from the researcher in terms
of social and communication skills. It implies professionalism, no judgement and awareness of
the environment influencing the interviewee (O’Leary, 2017).
Semi-structured interviews are a flexible type of interview that can start with prepared questions
but allows the interviewee to develop the answers and the interviewer to expand on the subject
with follow-up questions. Based on the literature review and the acknowledged project
management standard of PMI, the sampling frame consisted of people that work with or have
influence over projects, i.e. stakeholders within the Engineering unit. Individual interviews and
group interviews with all technical project managers, corporate project managers, purchaser and
project receiver were conducted during 40-50 minutes each. Also, a semi-structured interview
with an environmental manager at another pharmaceutical company was conducted in order to
discuss their project sustainability management and current use of LCA. Most interviews were
recorded upon confirmation, others were noted in words.
3.3.1 Qualitative data analysis Analysing qualitative results is a highly iterative process. Qualitative analysis is not based on a
stepwise methodology like many quantitative methods. It is of utter importance that the
researcher is aware of his/her pre-understandings, such as profession and personal opinions, in
order to avoid bias during analysis (Erlingsson & Brysiewicz, 2017). Content analysis is a
systematic approach to understand qualitative data. Content analysis starts with transcription,
thereafter condensing sentences into meaning units, coding, aggregating several codes in
categories and drawing of conclusions, see Table 1. Since not all interviews were recorded,
reconnecting with the interviewees was important to confirm a proper interpretation.
Table 1. Example of coding Original sentence Condensed Code Category If there are corporate goals, it would spread to local
production sites such as Stockholm and enable further
establishment of the targets in the organisation.
Corporate
goals would
enable local
targets
Corporate
goals
Policies and
goals
19
3.4 Quantitative case In this thesis, a case study was aimed to further answer objectives 1, 2, 3 and 4 by looking at a
finalised investment project and investigate how LCA could have been applied in any stage of the
process. The project was chosen since it was run according to the most recent update of the
project model XLPM, and secondly it was of manageable size for an environmental assessment in
this thesis. The purpose was to invest in a new final pasteurization equipment for filled and sealed
pharmaceutical bottles.
The LCA methodology based on ISO 14040 (ISO, 2018a). The LCA modelling was performed in
the well-known software SimaPro v. 8.4 with database EcoInvent v. 3.0 integrated. It was a
comparative attributional LCA of process design alternatives, Technology A and B.
Which technology has the highest environmental impact during their life cycle?
Which stage of the product life cycle contributes the most environmental impact?
3.4.1 Functional unit The functional unit represents a reference for comparing two equipment or processes with similar
function (Curran, 2015). Octapharma manufactures pharmaceuticals with different concentrations
and filled in various bottle sizes. The functional unit of the study is a 50 ml product bottle of the
most common concentration. The functional unit was triangulated against the official
environmental product declaration performed by Kedrion Biopharma, another plasma fractioning
company in which they also chose the most common concentration and size of the
pharmaceutical examined (Environdec, 2018a).
3.4.2 System boundaries
The system boundaries of the LCA were defined from the cradle to grave of both equipment.
Raw material extraction and processing, components manufacturing, use phase and the end-of-
life of the system, have been included into the model. The transportation of materials and
products between the different stages of the life cycle have been included in the model as well.
Foreground systems are the activities that are specific to the examined system, such as specific
machines or suppliers. Background activities are general non-specific data that a company
usually do not have influence over. In this study foreground activities are the use phase and
background activities consist of the extraction of the raw materials, manufacturing of the
equipment, the transport and the waste management.
The geographical boundaries for raw material is set to Europe for both technologies. The
production and manufacturing of components to Equipment A is in Sweden. Equipment B is
manufactured in Austria. Equipment B is in reality used in another factory, but in this study the
spatial boundary of the use phase is set to Sweden. Likewise, the geographic boundary of end-of-
life management stage was set to Sweden, as it was assumed that the waste generated both during
use phase and the disassembly phase will be treated within the Swedish waste management
system. The assessment should reflect the purchase of a new equipment, 25 years of lifetime and
waste management.
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Allocation
Allocation problems arise from “multi-functional” processes that produce more than one useful
output or perform more than one function (Curran, 2015). In this case the environmental load has
to be divided among these functions. There are three options to do so: 1. System expansion, 2.
Physical allocation 2. Allocation based on other relationship such as economic value (European
Commission Joint Research Centre (JRC), 2010).
In this case two multi-output allocation problem arises in the waste disposal scenario. The first
one concerns waste incineration due to the fact that incineration results in energy production as
well. The second problem concerns metal recycling which results in metal scrap that can be
further used in new products. In this LCA system expansion/substitution was used. In SimaPro
different databases offer different open loop recycling allocation methods which give incentive to
either recycle and design for recycling or use recycled material (Björklund, 2018). The database
used in this project was “allocation-default” meaning that environmental burden of the material is
divided among the various life cycles of the material, giving an incentive to recycle.
3.4.3 Impact category definitions
ReCiPe 2016 Midpoint (H) impact categories v 1.00. The following 17 midpoint indicators are included in the method:
▪ Global warming
▪ Stratospheric ozone depletion
▪ Ionising radiation
▪ Ozone formation, human
▪ Fine particulate matter formation
▪ Ozone formation, Terrestrial
▪ Terrestrial Acidification
▪ Freshwater eutrophication
▪ Terrestrial ecotoxicity
▪ Freshwater ecotoxicity
▪ Marine ecotoxicity
▪ Human carcinogenic toxicity
▪ Human non-carcinogenic toxicity
▪ Land use
▪ Mineral resource scarcity
▪ Fossil resource scarcity
▪ Water consumption
All the impact indicators were included in the analysis, as a holistic assessment of both
technologies was preferred, but important impacts are, according to the environmental manager at
Octapharma, energy use and water consumption. Therefore, the impact categories of water
consumption and global warming will be focused on. In addition, a cumulative energy demand
assessment method will be used to complement the results.
3.4.4 Normalisation and weighting
Normalisation is an interpretation tool to compare the results to a reference value in order to put
the results in a broader context. In many cases a total contribution to all impact categories in a
country is used as reference values. Weighting can further be considered as a step in which to
weight different impact categories as more important based on stakeholder’s interest.
Normalisation will not be used in this study and weighting will not be considered in this study
because it is not allowed according to the ISO standard ISO 14040 when performing comparative
studies (Curran, 2015).
21
3.5 Validity and reliability Validity is a concept that reflects on whether research captures “the truth”. Reproducibility is
defined as how well another researcher can repeat the study and obtain the same results (O’Leary,
2014). For example, the semi-structured interview would be difficult to reproduce as different
answers may be given at other times. This is also a company specific study, but it might be
applied to similar companies in the pharmaceutical industry or companies using the XLPM model
as their project management model and contributes a practical example of LCA to research
knowledge. LCA is performed according to the ISO framework 14040 to ensure validity.
22
4. Results and analysis This chapter presents the results in three parts, first the qualitative results and then the analysis of
the project management model. Lastly, the LCA case study is presented.
4.1 Qualitative analysis The interviews were conducted with several technical project managers, the Project Management
Organisation (PMO) who owns the project model XLPM, a purchaser, a project receiver and a
LEAN champion. The chapter is structured based on the interview questions presented in
Appendix II.
4.1.1 Integration of environmental aspects in investment projects
In general external environmental aspects are not explicitly assessed during the project analysis
and planning phase. “The project is run according to what the project sponsor has ordered, if
there are no specific requirements in the proposal it will not be incorporated later on”. Several
other project managers agree and emphasize that the project proposal is a key document, in which
environmental requirements should be incorporated already from the start. Otherwise it is up to
each individual project manager. It is also said, however, that the concept “Environment” needs
to be clarified since it includes numerous different concepts, in terms of both local aspects and
more long-term strategies.
The general main focus in project feasibility studies is on GMP compliance, for example in terms
of equipment and material choice. But also, on manufacturing process stability and minimization
of risk for loss of pharmaceutical product due to equipment failure for example.
The PMO group is responsible for the XLPM model. There are local PMOs on each production
site and their task is mainly to manage category A projects (from the complexity categorization of
A, B and C projects in the XLPM model, see section 4.2.2), but also to coordinate and support the
local project managers. All construction projects are class A categorized. In these projects, the
Byggvarubedömningen’s database is utilised for guidance on construction material’s
environmental impact (Byggvarubedömningen, 2018). Byggvarubedömningen provides
environmental data for construction material from a life cycle perspective, including chemical
risks. Construction projects that need to comply with GMP regulations are very specific
regarding quality requirements (such as specific demands for how to manage the air circulation in
clean room facilities) which not always goes hand in hand with energy efficiency. In addition,
when facilities are qualified and validated and thus approved by authorities, it is difficult to
change. On the other hand, the project managers (PM) add, many construction projects are non-
GMP facilities, such as office space, storage and break rooms. In addition, they emphasize the
opportunity for energy efficiency in specific improvement projects, looking at media systems and
non-qualified systems which are more easily replaceable, such as the cooling media system.
They continue by reflecting about the access to new technologies and solutions, whether to hire
consultants or use in-house competence, “in the planning and design phase there is an
opportunity to either delegate the responsibility to the planner or incorporate a specialized
23
consultant who could suggest new environmentally conscious materials”. Several PMs expressed
interest in environmental impacts caused by single-use versus traditional process equipment and
questioned which alternative is better. Some concluded, however, that single-use is more
operationally stable, implying less business risks. A mentioned risk for implementing
sustainability in projects is that the economic incentive for investing in new technology that has
not previously been used might risk the operational stability and quality, which is the single most
important criteria in every project.
4.1.2 Environmental policy and environmental targets
There is a shared view among the interviewees on whether both the environmental policy or the
specific environmental aspects are communicated and shaping investment projects. There are no
such connections in the project documents and related instructions steering the project
management process, but all interviewees are encouraging this. Environmental targets have been
established at the local engineering department before, but without major success. “If there are
corporate goals, it would spread to local production sites such as Stockholm and enable further
establishment of the targets in the organisation”.
4.1.3 The XLPM project model
All interviewees state that environmental considerations must be taken early in a project, one
particularly specifies before Tollgate 2 (TG2 in Figure 2). The User Requirement Specification
(URS) is a compilation of different demands from all internal project stakeholders which is
compiled before TG2 during workshops etc. According to one PM, there are generally no specific
demands from other departments than the end user, who requests an equipment that complies
with quality standards and can handle the requested production capacity. Several other project
managers agree. “I would like more specific demands from the sponsor and end user”.
Manufacturing process capacity (operational capacity) is the main focus of most equipment
investment projects according to the PMs. The end user shares the opinion on manufacturing
process capacity, but also points out that operational capacity goes hands in hand with
energy/resource efficient processes. He states that the responsibility to address environmental
aspects ought to be shared among all project stakeholders. One PM suggests that the technical
operation department (Teknisk drift) should be more involved in the requirement specification
(URS) by suggesting technical solutions in order to improve energy efficiency for example. In
addition, general technical solutions for energy efficiency is suggested to be included in Standard
Operating Procedure (SOP) 4052-OF, which is frequently used when compiling the requirement
specification.
Three project managers suggest checklists on key steps in the XLPM model: “Environmental
aspect review in the pre-study, in the design review, both basic and detailed and in the URS”.
Octapharma recently introduced a Lean review successfully into the project model. Lean
production is a management philosophy originating from Toyota production systems. The idea of
Lean is to identify and eliminate factors that are not creating value in order to enhance the
efficiency and quality of a process or organisation (Liker, 2004). The project Lean review was
24
previously conducted using a checklist, but currently a Lean discussion in the project team is
performed instead. “Lean has been implemented because the company prioritised it, employed
people with Lean competence and organised courses. Much like the Lean review, an
environmental review could be implemented”. The Environment Health Safety (EHS) review is
another supporting document in the project model today. A majority of the project managers state
that they are interpreting Environment Health Safety as work-health aspects only.
4.1.4 Purchasing process in investment projects
According to the XLPM model at least three different suppliers should be consulted in every
investment project. When assessing the case study project, a supplier review was performed with
at least two suppliers. But in various projects, the supplier already is decided in the
analysis/planning phase by the project manager. This is confirmed by the purchaser, who points
out that the purchaser role is involved in investment projects “in many cases too late”. According
to the project model the purchaser should be part of the projects from the planning phase.
Regarding supplier relations, Octapharma has framework agreements with several suppliers, for
example large consulting companies which are prioritised due to advantageous agreements. In
some projects therefore, single sourcing is conducted. There is also a corporate purchasing
department, which means that sometimes there are limited opportunities to decide locally on
different technologies and suppliers. Tech transfer is a process in which the technology and
equipment model already is decided and purchased, and the same solution is implemented in all
Octapharma’s production facilities.
4.1.5 Interview with an environmental manager at a different pharmaceutical company The environmental manager works at a large multinational pharmaceutical company. According
to the environmental manager a few LCAs have been conducted on pharmaceutical products,
with different scopes. The ACS CGI pharmaceutical roundtable database has been used as main
database. For one of their pharmaceuticals a change of catalyst chemical during API formulation
resulted in substantial environmental savings. Comparing e-factor, which is a measurement of the
total amount of waste per product, was an additional tool when comparing the original
manufacturing process to the altered manufacturing process. Transports were not included in this
example but is studied using carbon foot printing.
Regarding investment projects, the company considers environmental issues. Corporate targets,
as well as local targets, are incorporated in checklists in the investment project model. Officially
set targets regarding energy, water and waste are highly prioritized. LCAs are not used per se in
investment projects, but Life Cycle Costing (LCC) is. The environmental manager points out that
the larger project/investment, the more information is required for decision-making. There is an
importance in analysing greenhouse gas (GHG) emissions and emissions trading as it has an
effect on various investments. The sustainability manager recommends consistency regarding
internal environmental assessments, defining the priorities and starting off simple. In the case of
LCA a top-bottom approach is a good start. In conclusion, the use of LCA provides the company
with more information regarding emissions in the value chain, resulting in more informed
25
investment decisions and a base for improvement projects.
4.1.6 Opportunities identified to improve project sustainability In regard to implementing project sustainability management in engineering projects several
opportunities were identified throughout the interviews.
• Project managers with experience and ambitions in the environmental sustainability field.
• The newly formed PMO group has a great opportunity to suggest changes in XLPM
model, but also to communicate with and connect all Octapharma production sites.
• Operational capacity needs resource efficiency (=eco-efficiency) when production is
scaled-up.
• Non-GMP classified and qualified buildings and production systems are good starting
points in which to consider environmental aspects.
• Include technical solutions for energy-and water efficiency in SOP 4052-OF.
• Implement a name for external environment, either clarify Environment Health Safety
(EHS) concept or implement a new concept.
• The larger project/investment, the more information is required for decision-making.
4.1.7 Risks identified that may hinder project sustainability As well as opportunities, risks related to implementation of project sustainability management in
engineering projects were identified.
• Investment projects are on many occasions under a heavy time pressure.
• Implementation of changes to the XLPM model is not communicated effectively
internally
• Corporate and local environmental policies and significant environmental aspects are not
successfully communicated internally to project managers
• No measurable sustainability targets are established and communicated from the top
management organisation
• The notion “environment” is too widely used, as it includes everything from work
environment to water use locally to climate change in a long-term perspective. This is
related to the opportunity of clarifying and establish a concept for the external
environment throughout the company.
• Scarce resources in the purchasing department to follow every investment project in the
early phases.
• The URS are generally based on previously established processes and similar projects.
Therefore, it may lead to a risk that new technologies and other available solutions are not
considered.
26
4.2 Life cycle management in XLPM The interviews, literature study and document analysis of the XLPM project model and a few
ongoing/recently finalised projects are the foundation on which modifications are suggested in
order to incorporate an environmental life cycle management throughout the project phases and
the existing guidelines. Today, the “Human perspective” in the XLPM model includes
sustainability as an important consideration, referring to UN goals for a sustainable development,
but it does not state how to practically consider them.
The XLPM model consists of mandatory and supporting document templates that aid project
steering. Mandatory documents include project proposal, project charter, project plan, business
case and final report. Supporting documents include, among other, stakeholder analysis and risk
assessments. Key documents that should include a clearer external environmental perspective
were identified. In Figure 9 the documents are presented in terms of which project phase they are
used.
4.2.1 Stakeholder management Incorporating life cycle management in investment projects requires collaboration between the
different project roles. Stakeholder management is a very important methodology to acknowledge
in sustainability contexts. Participation of all stakeholders are key to together reach an agreement
on how to define environmental aspects/sustainability in each project (Marcelino-Sádaba et al.,
2015; Nilsson-Lindén et al., 2014). Internal projects, which this thesis is focused on, refers
mainly to internal stakeholders, which could be anyone within the company organization who
will be affected in some way by the project and therefore have an interest in influencing it.
Vogdell (2003), points out that stakeholder influence is most active in the beginning of a project
when project flexibility still is high. After execution is initiated it drops but increases once again
during the handover phase at the end of the project.
A power and interest matrix is frequently used in stakeholder analysis and is currently a tool in
XLPM. Knowing that stakeholder influence is highest in the beginning of the project it was
identified that current stakeholder management template in XLPM must include a stakeholder
Figure 9. XLPM and key documents in which to include environmental aspects
27
who address the importance of environmental aspects in projects. The project manager is overall
responsible for the success of the project and therefore also responsible for the success of
environmental strategies in a project. Without proper responsibility definitions Hallstedt et al.,
(2013) identified that sustainability aspects otherwise was considered late in the product
innovation process. The sustainability role definition is also central in environmental
management system ISO 14001 in order to succeed with environmental management
performance (ISO, 2018b). As a suggestion, the environmental manager could be part of the
steering group in certain projects which are identified as specifically impacting environmentally
strategic goals, for example through the category A, B and C assessment (see pt. 4.2.2 ) or be
consulted as a subject matter expert (SME) throughout the project in order to support the project
manager.
4.2.2 Project proposal and project charter The project proposal is the project idea initiation document written by the project sponsor. The
template includes project background, benefits and estimated investment cost as well as
regulatory impacts. According to the project managers in pt. 4.1 it is important that
environmental considerations already are requested in the beginning of an investment project. As
a suggestion, a new headline could be incorporated in which environmental concerns at this
initial project state should be listed and reflected upon. Overall, this template should include a
clearer connection between the project initiation process to corporate and local targets and
visions. The proposal should be able to answer how this project is contributing to corporate goals.
When the project is approved, the project charter is prepared by the project sponsor in order to
further define and refine the aims and scope of the project. By further referring to the importance
of early reflection on environmental sustainability, the environmental considerations from the
proposal should be presented as requirements from the project sponsor to the project manager to
include in the project plan.
Moreover, each new project is categorized according to A, B or C, in which A is a large project
in terms (1) investment cost, (2) effort in terms of human resources and (3) complexity. Category
A projects have complete project life cycles (according to Figure 1), while category B projects
skip TG3 and TG4 during project execution. Lastly, category C projects skip TG1, TG3 and TG4.
As of today, no criteria are specifically addressing environmental aspects as a complexity factor,
even though considerations are taken in large construction projects.
4.2.3 Risk assessment
The risk assessment is continuously developed document throughout both the analysis phase and
the planning phase of the project. At Octapharma general project risks, GMP compliance risks
and EHS (Environment Health Safety) risks are to be evaluated for every investment project. The
current project risk assessment template lists risk factors such as economic, time wise, customer
wise and technical risks to the project. In this template environmental risks are stated in terms of
natural disasters affecting the project outcome, rather than how a specific project causes
28
environmental risks. Therefore, external environmental risks throughout the life cycle will be the
focus of the EHS risk assessment in pt. 4.2.5.
4.2.4 User Requirement Specification
Early implementation of sustainability requirements design is essential as the majority of the
decisions at this point affect the entire environmental impacts throughout the product life cycle
(Marcelino-Sádaba et al., 2015). URS development stakes out the preliminary design/general
requirements for the project and the final design is established in the design qualification/review
process. A well-managed stakeholder analysis enables the URS development to include all
stakeholders/subject matter experts that are concerned, including the EHS department. At this
point the pre-study/feasibility study performed in the project analysis phase would present basic
process figures from current operations such as kWh or litres of water, to be used as reference
value for a future design.
As of today, project instruction 7040-OF mentions that a requirement specification should
include external environmental aspects but does not specify how to do that. It is important to
emphasize environmental requirements in the URS with the help of an eco-design framework
such as the ten golden rules for eco design in Table 2 (Luttropp & Lagerstedt, 2006). According
to the author these ten golden rules are very general and are to be customized by each company.
Table 2. Ten golden rules for eco design (Luttropp & Lagerstedt, 2006)
1 Do not use toxic substances and utilize closed loops for necessary but toxic ones.
2 Minimize energy and resource consumption in the production phase and transport through improved housekeeping
3 Use structural features and high-quality materials to minimize weight … in products … if such choices do not interfere with necessary flexibility, impact strength or other functional priorities.
4 Minimize energy and resource consumption in the usage phase, especially for products with the most significant aspects in the usage phase.
5 Promote repair and upgrading, especially for system-dependent products. (e.g. cell phones, computers and CD players).
6 Promote long life, especially for products with significant environmental aspects outside of the usage phase
7 Invest in better materials, surface treatments or structural arrangements to protect products from dirt, corrosion and wear, thereby ensuring reduced maintenance and longer product life.
8 Prearrange upgrading, repair and recycling through access ability, labelling, modules, breaking points and manuals.
9 Promote upgrading, repair and recycling by using few, simple, recycled, not blended materials and no alloys.
10 Use as few joining elements as possible and use screws, adhesives, welding, snap fits, geometric locking, etc. according to the life cycle scenario.
URS checklist
Consider learnings from current operations, feasibility study and similar investment projects
Stakeholders addressing environmental sustainability
29
Use preliminary risk assessment and EHS risk assessment
Use the 10 principles as guidelines to include requirements in the URS
4.2.5 Environment Health Safety (EHS) risk assessment The EHS risk assessment is today fully focused on work health related matters in investment
projects. The EHS risk assessment lists risk factors for work health (social sustainability), such as
heavy lifting, noisy environment etc. First, the environmental sustainability concept needs to be
clarified on whether EHS is chosen as the notion for external environment, see Risks that may
hinder project sustainability in pt. 4.1.6. At this point it is to be decided by the company itself to
whether a sustainability assessment is included in this EHS risk assessment or added as a separate
assessment.
Figure 10. Qualitative sustainability assessment
The idea of this qualitative tool (Figure 10) is to identify sustainability risks/environmental risks
the project result might cause (the asset life cycle marked in blue) and plan for mitigation
strategies. It also recognizes the connection between project life cycle and the asset life cycle, see
also Figure 4. In the beginning of the project there is less knowledge of impacts due to
preliminary design. As the project is pursued a more detailed design is developed, leading to
more knowledge of impacts. Therefore, working in parallel with URS, the preliminary design and
the EHS risk assessment is necessary.
The environmental risk assessment is initially based on brain storming. One can draw several
asset life cycles depending on the type of project or the effect on the pharmaceutical product
(product life cycle). Thereafter, environmental aspects that concern the asset development should
be identified for each life cycle step. The broad overarching environmental aspects to be included
are the main categories from Global Reporting Initiative’s 300 Standards (GRI, 2018). See
Appendix III for all environmental aspects within each category.
30
GRI 301: Materials
GRI 302: Energy
GRI 303: Water and Effluents
GRI 304: Biodiversity
GRI 305: Emissions
GRI 306: Effluents and Waste
GRI 307: Environmental Compliance
GRI 308: Supplier Environmental Assessment
Furthermore, estimate the degree of influence over each life cycle phase in order to establish the
scope of the assessment in line with ISO 14001:2015 (ISO, 2018b). At this point various tools
can support the risk assessment and decision making. LCC will be discussed below, while LCA
will be further discussed and implemented in pt. 4.3. As a combination of a screening LCA and
LCC Mata et al., (2012) suggests these ten indicator in Table 3 to be evaluated for the
pharmaceutical products or processes. This is primarily applicable for a gate-to-gate perspective
during operation/use phase, see pt. 2.3.
Table 3. Indicators for sustainability evaluation (Mata et al., 2012).
Indicator Unit Description
Energy intensity MJ/vial Total energy consumed in the production of one vial
Process mass
intensity
kg/vial Total amount of non-renewable resources needed to obtain a unit mass of product
Process water
intensity
L/vial Total amount of water required to obtain a unit mass of product
Potential chemical
risk
- Potential risk to human health associated with manipulation, storage and use of hazardous chemical compounds
Carbon footprint kg CO2-eq/vial Potential contribution of different GHG emissions to global warming
Freshwater aquatic
toxicity
kg 1,4-
dichlorobenzene-
eq/vial
Measures the impact of substances emitted to the aquatic environment during manufacture activities
Net cash flow
generated
€ /vial It equals cash recipients minus cash payments over a given period of time or, net profit plus amounts charged off for depreciation, depletion, and amortization
Direct employment persons/vial Number of persons involved in the pharmaceutical product manufacture per unit of product
EHS review checklist
Does the project contribute to or negatively impact the environmental objectives of the company?
Identify environmental aspects concerned throughout the three life cycle stages of construction, use and disposal.
Estimate the degree of influence over the differ ent life cycle stages of the asset
Estimate which phase(s) of the asset life cycle that has the most impact?
31
How can the environmental impacts be mitigated?
Decisions-supporting tools that could help the project
4.2.6 Design review The design review process is the last step before the true project execution begins. This is where
the requirements from the URS are reviewed and assessed whether they are fulfilled in the final
design. Therefore, the eco design principles from the URS and the EHS risk assessment are once
again useful when establishing the detailed design. A multi criteria approach is of course
essential. The EHS risk assessment should represent one of the criteria together with cost,
reliability, business strategies etc. In projects designing certain manufacturing lines and process
machines a number of criteria need to be evaluated before choosing a certain manufacturing
process, including the capital investment, the cost of goods, net present value (NPV), internal rate
of return (IRR), process risks, and the manufacturing process timeline (Ramasamy et al., 2015).
In order to assess the economic aspect of a proposed design, environmental Life Cycle Costing
(eLCC) is useful as it is viewed as one of the key tools of LCM (Rebitzer & Hunkeler, 2003). A
conventional financial LCC (fLCC) is an accounting tool for investments identifying the cash
flows during a product life cycle. Similar to a CBA, the result is heavily dependent on the chosen
discount rate. A discount rate corresponds to the extent to which organizations prefer to consume
and/or invest the money today rather than tomorrow. The higher discount rate the lower weight is
given to future costs and benefits compared to costs and benefits today. Environmental LCC
(eLCC) builds upon the fLCC extending the costs to include all the costs associated with the life
cycle of a product (Rebitzer & Hunkeler, 2003). Comparing LCC with LCA, the eLCC tool does
not monetize carbon emissions, but rather includes costs such as carbon taxes and disposal costs,
thus making eLCC and LCA complementary tools (Hoogmartens et al., 2014).
The eLCC process is not standardised, but Society of Environmental Toxicology and Chemistry
(SETAC) published in 2011 “Life cycle costing- a code of practice” (Swarr, 2011). The Swedish
governmental agency Upphandlingsmyndigheten (The National Agency for Public Procurement)
presents guidelines on how to incorporate LCC in procurement processes. The agency has
published an LCC tool in which investment costs, using time (physical life time or time of the
agreement), running costs and decommissioning costs are considered. LCC can be applied in four
phases of the procurement process: requirement analysis, procurement documents, evaluation of
different offers, and follow-up process (Upphandlingsmyndigheten, 2018). For Octapharma,
similar simple tools could be utilised, especially in projects comparing different production
equipment and technological solutions. At present, the XLPM model or none of the related
instructions relates to the physical disposal of the asset at the decommissioning stage. A
recommendation is to include a plan for practical handling of decommissioning of the asset/assets
already in the design review.
32
4.2.7 Purchasing
According to Nilsson-Lindén et al., (2014) the purchasing department has a key role to play in
life cycle management. As LCM needs to be horizontally integrated in the company and in the
investment projects, sustainability engaged purchasers is important when communicating with
suppliers. Nilsson-Lindén et al., (2014) suggest that suppliers can promote sustainability due to
an interrelationship of both the own company and the supplier. According to Hallstedt et al.,
(2013) purchasers have widespread knowledge of a supplier’s products and should therefore be
involved early in the project innovation phase. Purchasers build relationships with suppliers and
have knowledge about manufacturing processes which should be used as input in the investment
process. During the interviews with the project managers the access to sustainable solutions in
technical projects came up for discussion. Purchasers could definitely be an important resource in
accessing products and technical solutions.
Purchasers are responsible for communicating Octapharma’s environmental requirements to
suppliers. In addition, providing information to suppliers that environmental information such as
material, transport, use phase (energy and water consumption) and disposal options are of
interest. The asset life cycle (of an equipment) in investment projects can be environmentally
assessed by Environmental Product Declaration (EPD) standards, which are relatively new types
of product declarations, informing stakeholders about the environmental footprint of a certain
product. The European Commission association Environdec provides a database with various
EPDs according to the ISO 14025:2010 standard of environmental declarations type III (ISO,
2018a). Product category rules (PCR) are defined in ISO 14025 as a set of specific rules,
requirements and guidelines for developing Type III environmental declarations for one or more
product categories. There are around 40 PCRs recently published and many more in the pipeline,
implying that EPDs will be more common and distributed in multiple line of businesses
(Environdec, 2018b). EPDs main purpose is to support environmentally conscious procurement.
Integrating a systematic thinking of EPD in the project procurement process is one way of
making informed decisions. There are a number of other organizational strategies to incorporate
sustainable or green procurement, which is out of scope for this thesis.
4.2.8 Final report and hand-over
The final report is a concluding document that sums up the project delivery and hand-over to the
line organisation. Attached to the final report are some of the important project documents. This
does not however include the EHS risk assessment. As a result, there is a risk that future
learnings may vanish. Also, inclusion of the plan for disposal from the design review in the final
report is important in order to close the loop on the project life cycle approach.
As each project outcome contributes to various environmental impacts investment projects could,
as part of reporting financial figures, also report sustainability indicators or EPIs (environmental
performance indicators). Epstein et al., (2014) provides an extensive list of EPIs and suggests that
sustainability metrics are used for internal reporting purposes or as a basis for external annual
sustainability reporting. EPIs reported in investment projects can display how a particular project
33
reduces electricity consumption, and a comparison with the replaced/alternative solution. In
Nilsson-Lindén et al., (2014) LCM study, EPIs clarified what was expected from the project,
especially related to Design for Environment requirements. It was found that when a project or
new process was not followed up, the risk for “business as usual” was considerable. If instead
monitoring of the projects was pursued with clear KPIs/EPIs for each project, non-compliance
with the Design for Environment requirements would have consequences.
EMS such as ISO 14001 are based on the workflow of a “Plan-Do-Check-Act phase” to
encourage follow up implemented procedures. Regarding the technical solutions, in order to
gather experience before next investment, a review 6 months later could be conducted together
with the receiving organisation and technical support organisation. A review has many
advantages such as a basis for measurement of targets, collection of process data generated in the
project, summary of lessons learned and identification of future project ideas.
4.3 Case study of a finalised investment project The aim of the investment project was to purchase and install a new pasteurization equipment.
The project was initiated in order to meet the demands of increased pharmaceutical production.
According to one of the project managers that was interviewed, the project was supposed to result
in a tech transfer of Technology B that was already decided at corporate level, but in the end
another solution (Technology A) was chosen due to the fact that a similar solution was already up
and running at the Stockholm plant.
Technology A is a steel bath, see Figure 11. The bath
is filled with warm water from two polypropylene
tanks and sterilizing the product bottles at 60 degrees
during 12h.
Technology B is an autoclave, see Figure 12. An
autoclave on the other hand is a pressure chamber,
creating almost vacuum before treating the goods
with pressured hot air, steam or water. There are
many different types of autoclaves on the market.
In this case, Technology B is a steam /air
autoclave autoclaving the products during 12h.
The theory behind the technologies
The purpose of pasteurization is virus
inactivation. Pasteurisation is one of the last steps
in the manufacturing chain of the filled product.
Pasteurisation is the method of increasing the
temperature for a certain time period in order to
kill off viruses. It is common in the food
processing industry and the pharmaceutical
industry. There are several technologies that can Figure 12. Technology B (SBM, 2020)
Figure 11. Technology A
34
be used to achieve virus inactivation. Both equipment studied in this assessment are so called
Thermal Technologies. Other options are non-thermal technologies. A previous LCA comparing
four technologies with a gate-to-gate perspective concluded that thermal pasteurization
technologies showed high environmental load for the autoclave solution in nearly all the impact
categories, partly due to that in this particular study steam was generated by direct combustion of
fossil fuels and not electricity (Pardo & Zufía, 2012).
4.3.1 Life cycle inventory Primary data has been obtained through various emails and interviews with employees and
managers. Direct measurement of electricity consumption during one week was possible for
Technology A. Some data were collected from an internal report based an energy audit to comply
with the requirements for the Swedish regulations of energy audits in large enterprises.
Secondary data has been obtained from EcoInvent 3.0 database and various peer-reviewed
scientific publications and brochures from manufacturers (Wernet et al., 2016). Figure 15 is
presenting both assets’ life cycles in detail.
Figure 15. Detailed flowchart of technology A (red) and for technology B (blue).
Assumptions and limitations
Production location is at each supplier and that the product is not purchased from
additional suppliers.
The intermediate transport within the production process and assembly is not considered.
The energy use for assembling or disassembling the product is not considered.
Packaging during transport is excluded.
Municipal wastewater treatment is excluded
35
Infrastructure and capital goods are not included for all foreground processes and data,
but for background data from EcoInvent 3.0.
Automation components to control both equipment are excluded due to data gap.
25 years lifetime for each technology= 46 800 operating hours
Raw material extraction and manufacturing
The production of high-quality stainless steel starts with mining iron ore or collection of scrap
metals. The raw iron ore or metal scrap is placed into an electric arc or blast furnace, melted and
alloyed to other metals. The steelmaking process is lowering the carbon content through various
steps resulting in sheets or bars. This is the raw material for further manufacturing of
pharmaceutical equipment. According to Jernkontoret 70% of the stainless steel used in Sweden
is virgin material, while 30% is based on recycled content (Jernkontoret, 2015). Table 4 describes
the material and processes used in EcoInvent 3.0.
Table 4. Steel material
Part Material Weight/FU Processing in EcoInvent Material in EcoInvent Bath 316L
stainless steel
0.14 kg Energy and auxilliary inputs, metal working machine {RER}| with process heat from natural gas | Alloc Def, S
Steel, chromium steel 18/8 {RER}| steel production, converter, chromium steel 18/8 | Alloc Def, S
0.06 kg “
Steel, chromium steel 18/8 {RER}| steel production, electric, chromium steel 18/8 | Alloc Def, S
Autoclave 316L stainless steel
0.252 kg “
Steel, chromium steel 18/8 {RER}| steel production, electric, chromium steel 18/8 | Alloc Def, S
0.108 kg
“
Steel, chromium steel 18/8 {RER}| steel production, converter, chromium steel 18/8 | Alloc Def, S
The production of polypropylene starts with the raw material propylene which can be produced in
various ways from the raw material fossil oil. Propene is further polymerized in the presence of a
catalyst, resulting in polypropene pellets, which is further refined into products, by for example
injection moulding. In Table 5 the material and processes used in EcoInvent 3.0 is presented.
Table 5. Plastic material
Part Material Weight/FU Material in EcoInvent Processing in EcoInvent Water tanks Polypropylene
(PP)
0.02 kg Polypropylene, granulate {RER}| production | Alloc Def, S
Injection moulding {RER}| processing | Alloc Def, S (0,0201 kg process)
Transport
The transport distance for Technology A is estimated from Norrköping to Stockholm, Sweden,
which is 160 km by lorry. Transport estimation for Technology B is from the factory in Austria to
Stockholm, Sweden, a distance of 1800 km assumed to be travelled by lorry. In Table 6 the data
used for modelling in EcoInvent 3.0 is presented.
36
Table 6. Transport
Part Mode of transport Distance/FU Process in EcoInvent Technology A
Lorry 35.2 kgkm (160 km)
Transport, freight, lorry 16-32 metric ton, EURO5 {RER}| transport, freight, lorry >32 metric ton, EURO5 | Alloc Def, S
Technology B
Lorry 648 kgkm (1800 km)
Transport, freight, lorry 16-32 metric ton, EURO5 {RER}| transport, freight, lorry >32 metric ton, EURO5 | Alloc Def, S
Use phase
Technology A can handle 18 000 functional units per treatment cycle, while Technology B only
can handle 16 650. Technology A consumes 60 kWh/cycle, which was measured during one
week of operation. 7.5 m3 Pure Water (PW) is required to fill the bath and the treatment time is
12 h. In many industries, among them food processing and pharmaceutical industry, Pure Water
is essential. Pure Water is water that does not contain any electrolytes, a normal component of
regular tap water. Stockholm county water is purified in three steps at Octapharma, by water
softener, Reverse Osmosis and Electrodialysis. The estimated power consumption of these
processes is shown in Table 7.
Technology B power and media consumption is based on contact with the manufacturer.
According to the manufacturer the pasteurization on average consumes 400 kg steam, 10 m3
cooling water and 30 m3 of compressed air. Power demand for the machine is 20 kW and the
treatment time is 12 h. According to the manufacturer the media consumption is to a large extent
depending on the load of the machine. As this is the only data available one has to consider that
this may not reflect the actual usage of Technology B.
Similar to Pure Water production, many industries produce process steam in order to provide heat
to various other process at the production plant, such as distillation processes. For Technology B,
filtered plant steam is used, which is plant steam that is filtered to remove particles typically
greater than five micrometre (µm) pore size. For this LCA, it is assumed that filtered plant steam
is equal to plant steam. The plant steam is generated by electricity and the back-up boiler running
on low sulphured fuel oil Eo1. The percentage of electricity/oil is varying significantly one year
to another, but the statistics from a report a few years ago are 60% electricity and 40% low
sulphured fuel oil Eo1. The pressurized air is produced using a compressor running on electricity.
The outlet pressure is 7 Bar.
37
Table 7. Media overview
Tech. Media type Consumption Per FU Process in EcoInvent
A Purified Water (PW)
Avg. consumption of a Brackish water Reverse Osmosis: 2 kWh/m3. Avg. consumption of an Electro Dialysis plant: 1,6kWh/m3 (Al-Karaghouli & Kazmerski, 2013). 7.5 m3 water × 3.6 kWh= 27 kWh/cycle
0.0015 kWh
Electricity, low voltage {SE}| market for | Alloc Def, S
B
Process steam
0.5 kWh/kg steam × 400kg steam =200 kWh/cycle
0.0072
kWh
0.0048
kWh
Electricity, low voltage {SE}| market for | Alloc Def, S Electricity, high voltage {SE}| electricity production, oil | Alloc Def, S
Compressed air
30 m3 0.0018 m3
Compressed air, 600 kPa gauge {RER}| compressed air production, 600 kPa gauge, >30kW, average generation | Alloc Def, S
Regarding maintenance and chemical use both equipment has similar requirements with monthly
cleaning procedures. In Table 8 the consumption per functional unit of water, cleaning agent and
electricity is presented.
Table 8. Use phase
Material Technology A/FU Technology B/FU Process in EcoInvent Tap water 0.59 l
0.63 l Tap water {Europe without Switzerland}| market for |
Alloc Def, S
Electricity 0.0033 kWh
0.014 kWh Electricity, low voltage {SE}| market for | Alloc Def, S
Cleaning detergent
0.0000094 l 0.000010 l Alkylbenzene sulfonate, linear, petrochemical {RER}| production | Alloc Def, S
Waste management scenario
The waste management scenario is based on communication with a Swedish metal recycling
company. The metal components of both equipment are assumed to be 100% recycled. The
polypropylene tanks from Technology A are assumed to be incinerated. Waste management for
the polypropylene is assumed to take place in Västerås, 112 km from the company. Metal
recycling is assumed to be conducted in Hallstahammar 128km from the company (Jernkontoret,
2018). In Table 9 the waste management processes and data is presented.
38
Table 9. Waste management
Tech. Material Distance/FU Transport Waste management in EcoInvent A
316L stainless steel
26 kgkm (128km)
Transport, freight, lorry 16-32 metric ton, EURO5 {RER}| transport, freight, lorry 16-32 metric ton, EURO5 | Alloc Def, S
Steel and iron (waste treatment) {GLO}| recycling of steel and iron | Alloc Def, S
PP
2.3 kgkm (112 km) ”
Waste polypropylene {CH}| treatment of, municipal incineration with fly ash extraction | Alloc Def, S
B 316L stainless steel
46 kgkm (128km) ”
Steel and iron (waste treatment) {GLO}| recycling of steel and iron | Alloc Def, S
In EcoInvent v. 3.0 recycling process the energy consumption and transport for recycling has to
be added manually. Thus, it is assumed that for sorting, shredding and remelting the steel, the
electricity consumption is 580 kWh/ton scrap = 0.58kWh/kg (Norgate, 2013). Incineration of
waste in Sweden gives rise to electricity and heat production as well. According to Avfall Sverige
statistics from 2017 the combined heat and power plant in Västerås on average produces 2.5 kWh
district heating and 0.6 kWh electricity per kilo of waste (Avfall Sverige, 2018).
38
4.3.2 Life cycle impact assessment
Figure 13. Results of the LCA Technology B Technology A
Method: ReCiPe 2016 Midpoint (H) V1.00 / Characterization
Comparing 1 p 'Life cycle of Technology B' with 1 p 'Life cycle of Technology A';
Global
warming
Stratospheric
ozone depleti
Ionizing
radiation
Ozone formati
on, Human
Fine particulat
e matter forma
Ozone formati
on, Terrestrial
Terrestrial
acidification
Freshwater
eutrophicatio
Terrestrial
ecotoxicity
Freshwater
ecotoxicity
Marine
ecotoxicity
Human carcino
genic toxicity
Human non
-carcinogenic
Land use Mineral resour
ce scarcity
Fossil resource
scarcity
Water consum
ption
%
100
95
90
85
80
75
70
65
60
55
50
45
40
35
30
25
20
15
10
5
Life cycle of Technology B Life cycle of Technology A
39
Figure 16 shows the results of the total contribution of the manufacturing phase, the use
phase assuming 46 800 h operation hours for 25 years and the disposal scenario. As seen in
Figure 13 Technology B generally has a high impact, at least 20% more (in terms of water
consumption, the bars furthest to the right) than Technology A in all 17 impact categories.
Technology B is contributing almost 10 times as much as Technology A to Global Warming
during 25 years of operation (the bars furthest to the left).
Below in the network tree for the Global warming impact (Figure 14) one can identify the
production of process steam as the largest contributor.
Figure 14. Characterization of Global Warming impact for Technology B
For Technology A the characterization of global warming impact is presented in Figure 15.
Figure 15. Characterization of Global Warming impact for Technology A.
For Technology A the production of virgin steel as well as the use phase electricity
contributes most to global warming. The disposal scenario for both technologies are
resulting in a net reduction of global warming effects due to steel recycling.
40
Since water consumption and energy consumption are significant environmental aspects for
Octapharma a Cumulative Energy Demand impact assessment further confirms Technology
B as more resource demanding, see Figure 16. From left to right the impact categories are:
1. Non-renewal, fossil
2. Non-renewal, nuclear
3. Non-renewable biomass
4. Renwable, biomass
5. Renewable, wind solar geothermal
6. Renewable, water
Figure 16. Cumulative energy demand Technology B Technology A
Sensitivity analysis is an evaluation of which assumptions that are influencing the final
results, i.e. the robustness of the results. This sensitivity analysis was scenario based
considered which assumptions/data that may affect the final results. Scenario 1 considered if
only electricity from Swedish market mix instead of both oil and electricity is used for the
production of process steam for Technology B. As seen in Figure 14 a majority of the global
warming impact is derived from the production of electricity from low-sulphur oil in Figure
14. The results in Figure 17 show that Technology B impact in this case is lowered
significantly from ten to three times as much as Technology A in terms of global warming
Scenario 2 considered if the Technology B had the same transport distance as Technology B.
As seen in Figure 17, the transport distance is negligible compared to 25 years of operation.
Scenario 3 considered if Technology A had a shorter lifetime of 20 years and thus 25% more
of Technology A is required for the assumed time frame of 25 years. As seen in Figure 17
the water consumption is then equal for both technologies.
Method: Cumulative Energy Demand V1.09 / Cumulative energy demand / Characterization
Comparing 1 p 'Life cycle of Technology B' with 1 p 'Life cycle of Technology A';
Non renewable, fossil Non-renewable, nuclear Non-renewable, biomass Renewable, biomass Renewable, wind, solar, geothe Renewable, water
%
100
95
90
85
80
75
70
65
60
55
50
45
40
35
30
25
20
15
10
5
Life cycle of Technology B Life cycle of Technology A
41
Figure 17. Results of sensitivity scenarios
4.3.3 Interpretation The results show that Equipment B = the autoclave has a higher environmental impact
throughout the life cycle than Equipment A. This is mainly due to the heavier construction
which on the same time can handle fewer pharmaceutical bottles per cycle of running time.
When analysing the life cycle phases, the manufacturing phase of stainless steel generates a
high environmental impact, especially in terms of energy intensity. However, the use phase
is contributing the most when assuming 25 years of operation. Technology B is requiring
more energy during use phase due to several media systems supporting the machine. One of
the media systems is partly running on low sulphured fuel oil Eo1, significantly impacting
the global warming category. However, worth noting is that the EcoInvent process chosen is
high voltage electricity generated by oil, which is not fully representing the reality, i.e.
showing a higher impact. In addition, the ratio of media produced by fuel oil and electricity
seem to vary on year to year basis, which also is an uncertainty in the analysis.
Water consumption is higher for Technology B as well. When considering another utility
data sheet based on another model (same manufacturer) of the autoclave, the cooling water
consumption can actually vary between 6.5 and 25 m3 per cycle. In fact, 6.5 m3 water plus
450kg steam is less than Technology A consumption per cycle. Even so, Technology B is
worse in relation to the remaining impact categories. In Technology A, the steel construction
is significantly lighter, and the use phase is more energy-efficient than Technology B. In
cases where the use phase is identified as the hot-spot life cycle stage there is an opportunity
to design energy efficient solutions.
Regarding the polypropylene (PP) tanks, they are considered to have a lifetime of 15 years,
therefore 1.5 PP tanks were assumed to be consumed during 25 years of operation. Even
though PP is fossil-based the contribution to global warming is negligible. However, worth
0
10
20
30
40
50
60
70
80
90
100
Globalwarming
Waterconsumption
Globalwarming
Waterconsumption
Globalwarming
Waterconsumption
Globalwarming
Waterconsumption
Ref scenario Scenario 1 Scenario 2 Scenario 3
%Sensitivity analysis
Tech A Tech B
42
emphasizing is that the components of the models are very simplified, no pumps or detailed
material of smaller parts or automation components are included due to lack of detailed
information. Despite the different transport for Tech A and B, the transport distance is not a
major contribution in the total footprint of global warming, see Figure 17. However, this
study does not consider transport prior to the customer delivery.
For the end-of-life scenario, the LCA database chosen is dividing the burden of recycling
between each user cycles, generating a net positive effect for recycling activities. Other
databases put the entire burden on the first user, thus would the results not look so positive
for the end-of life phase unless recycled material was used from the beginning. In
conclusion, the research questions initiating this assessment were the following.
Which one of these products has the highest environmental impact during their life cycle?
The results show that the chosen and implemented Technology A has a radically lower
environmental impact than Technology B
Which stage of the product life cycle contributes the most environmental impact?
The use phase contributes mostly to the overall environmental impact when assuming 25
years of operation.
Already in the life cycle inventory phase it was evident that Technology B would cause
larger environmental impacts, which may also be the case in other investment projects.
Therefore, a basic life cycle inventory study could reveal much information about the
environmental impact of both products, thus reducing the time effort in investment projects.
Furthermore, in a real investment situation more precise utility data for Technology B would
be accessible via the supplier faster than in this master thesis. In this study, however the
exact amount of pharmaceutical load was accessed, which was used as a functional unit. In a
real investment project, a sensitivity analysis of +/- the estimated load of pharmaceutical
could be used. Furthermore, a close cooperation with the other manufacturing plants within
Octapharma can support fast collection of inventory data, especially if tech transfers are
performed, see pt. 4.1.4.
43
5. Discussion The research question initiating the thesis was How can a life cycle approach help the
environmental performance and be integrated into current practices of the project
management model and create value for the company?
Different methodological approaches were chosen to answer each part of the question. First a
literature review aimed to give a foundation on the subject, then a qualitative assessment
provided current status analysis, identifying risks and opportunities in terms of implementing
life cycle management in investment projects. Thereafter, several suggestions were laid out
in order to improve the project management model. Lastly, one of the most common tools in
life cycle management, LCA, were discussed in terms of the biopharmaceutical industry and
a practical application on a type of investment project named “equipment upgrade” was
performed.
5.1 LCM in XPLM In general, project management guidelines such as Project management Institute PMBOK
does not consider the Triple Bottom Line as a holistic concept but emphasize the economic
sustainability in terms of cost efficiency. There are several examples of project management
highlighting economic aspects and work social issues, such as (Martens & Carvalho, 2017)
survey with 70 Brazilian project managers concluding that the economic and social aspects
of the triple bottom line are both considered and viewed as more important than
environmental and natural resource-related aspects.
In this thesis the qualitative analysis highlighted many opportunities, such as engaged project
managers, cross-collaboration opportunities between production sites and opportunities for
improved internal communication. However, the biggest risk to successful implementation,
appeared in the document analysis. It seemed as “work environment” and “external
environment” are used interchangeably in both XLPM templates but also in the company in
general. In order to increase the “external environmental perspective” in terms of life cycle
management, a common understanding of the meaning of different concepts needs to be in
place. A suggestion was to clarify the notion EHS in the SOP system and in the document
templates steering project management.
How can LCM be incorporated in project management? The entire literature used in this
thesis advocate for early integration of environmental aspects in product development. In
order for early integration, corporate/top management sustainability targets are important to
set the bar and enable fair resource allocation for investment projects. Amine et al., (2014),
point out that sustainability success is rare unless it is incorporated in the overall business
strategy. Such strategy should also be represented at department level. As shown in the
interviews in this thesis, at least one project management department tried to set their own
targets, but according to the PMs, it would be preferable with corporate targets that spread
vertically in the organisation. Furthermore, the interviews show that no environmental
requirements are considered at project initiation stage or in the requirement list compilation.
Hallstedt et al., (2013) who examined the integration of sustainability in product innovation
projects at six industrial companies by interviewing key stakeholders in the product
44
innovation process, also describe that the environmental requirements were not considered
when compiling the project requirement list (URS). It was also found that sustainability was
not included at a high level in advanced engineering, instead technical features and business
opportunities were prioritized. As a solution to the issue, it was suggested that a job position
advocating for environmental requirements in engineering projects should be implemented.
Just like Hallstedt et al., (2013) many scientific research papers discuss the incorporation of
environmental aspects in product development for customer use. Designing products for
internal use, such as unit processes at a manufacturing plant discussed in this thesis, is to
some extent different because the customer is the company itself. It does not require either
“selling” eco-friendly products or meet external user requirements of the customer. In
internal projects the “customer” needs to be defined in order to take into account all
requirements.
Hallstedt et al., (2013) and Nilsson-Lindén et al., (2014) are two of the most important
scientific studies that laid the foundation for understanding LCM and sustainable product
development in this thesis. Hallstedt et al., (2013) have developed a number of principles of
how to include sustainability in product development projects. In addition, Nilsson-Lindén et
al., (2014) have developed principles for the integration of LCM in organisations. Many of
the principles from both papers resemble one and another and below they will be discussed
against the findings of this thesis.
1) Ensure organizational support from senior management;
Senior management engagement establishes a baseline for how sustainability is to be
interpreted at each particular company. Furthermore, a business strategy alignment with
sustainability ambitions needs to be established in order for sustainability to be integrated
into daily operations. Nilsson-Lindén et al., (2014) highlights the integration of sustainability
in company operations in contrast to pursue sustainability as a side activity.
2) Efficiently bring in a sustainability perspective early in the product innovation processes;
In terms of investment projects the important environmental aspects of the Stockholm site
are already defined. As suggested in pt 4.2 the identified environmental aspects are to be
reflected on in every project, already in the project charter and project proposal phase.
Further environmental requirements are considered in User Requirement Specification. And
lastly, the EHS risk assessment needs to be considered equally early as the general risk
assessment and be further analysed when more data is available as the design is being
developed.
3) Utilize knowledge and experience of procurement staff in the earliest phases of the
process;
The interviewees in this thesis points towards that the purchasing department is involved late
in the project life cycle. Similar to Hallstedt et al., (2013), the project stakeholder wished
that the responsible purchaser should be involved earlier in the project, whose expertise
regarding suppliers and manufacturing technologies could improve project performance
significantly.
45
4) Include social aspects across the product life cycle and its value chain;
Social aspects as in work environmental aspects are considered in every project. Other social
aspects are out of scope for this thesis.
5) Assign responsibility for sustainability implementation in the product innovation process;
The responsibility for sustainability implementation in projects was identified as very
important in the results, see pt. 4.2.1. The responsibility of addressing environmental
requirements was also discussed among the stakeholders and interviewees. Without proper
role definitions Hallstedt et al., (2013) identified that sustainability aspects otherwise was
considered late in the product innovation process. The sponsor, as responsible for writing the
project proposal and charter, plays an important role of how the project is defined. At the
same time, the end user interest and requirements are highly valued.
As ultimately responsible for the project, the project manager is responsible for sustainability
related questions. On the other hand, there is a risk that sustainability is a responsibility put
on top of everything else that is to be done in a project. As suggested in pt. 4.2.1 the
environmental manager could support projects as Subject Matter Expert or be part of the
project steering group. Furthermore, education for project managers would provide the PMs
with deeper knowledge regarding environmental impacts and life cycle management such as
the course in “Applied life cycle thinking” organised by Swedish Life Cycle Center
(Swedish Life Cycle Center, 2018). In the long run an environmental support function could
be implemented that aid project managers and other stakeholders in the requirements and
risk identification throughout the project life cycle. Furthermore, there is a great opportunity
in engaging external project planners involved in investment projects and use their expertise
regarding sustainable technical solutions as suggested by the interviewees.
6) Have a systematic way for knowledge sharing and competence building in the
sustainability field to inform decisions taken in future product development projects;
It is important to ensure that knowledge from already conducted LCAs is used in future
projects. As suggested in the results, see pt 4.2.8 a review process a few months after the
finalised project with projects stakeholders including end-user and the technical unit could
result in a portfolio of new proposals for pure sustainability and improvement projects.
In general, when it comes to sustainability and LCM, networks for knowledge sharing are
very important in making sustainability initiatives happen, especially internally. Those
networks for discussion and idea sharing is important as it may be difficult to implement
sustainability initiatives by one-self (Nilsson-Lindén et al., 2014). Currently, the
environmental manager is engaged in several networks, for example an association with
environmental managers in the pharmaceutical industry.
7) Utilize tools for guiding decisions as a complement for assessment tools;
A qualitative LCA-tool is suggested in the EHS risk assessment. LCA as a quantitative tool
will be further discussed below in pt. 5.2. Further there is a need to implement a
46
sustainability perspective in already existing tools, such as the suggested changes of the
project management model.
As seen in the principles above, life cycle considerations in investment projects cannot really
been viewed in isolation to the rest of the company operations. LCM and ISO 14001
certification is a further field to explore. The core of the ISO standard is a Plan-Do-Check-
Act cycle encouraging as well as requiring the organisation to implement “constant
improvements”. Many of the suggestions in this thesis is in accordance with the standard
ISO14001, ISO 14004, ISO 14006 and ISO 14062. Both regarding organisational aspects
and more technical data aspects in incorporating life cycle management in the project
organisation and in an organisation as a whole.
5.2 Investment project LCA The results of the LCA shows that one of the technologies has a considerably higher
environmental footprint than the other one. It was evident already in the inventory phase that
Technology B would cause larger environmental impact. As a result, a life cycle inventory
study together with environmental Life Cycle Costing might be useful as a first tool prior to
performing an LCA, especially in time-limited investment projects. The case study LCA
performed is a rather simple LCA as it only includes direct impacts from each technology. A
step further developing a more complete LCA study would be to, in the use phase add the
energy consumption for the manufacturing facility such as heating, ventilation and
sanitation. However, during the data collection step there was a difficulty in receiving data
on the media system consumption. Ideally this could be monitored closer, as these systems
are the backbone of the production plant. If data is more readily available, performing
another LCA would not be a large step. As this LCA is only a small part of a long chain of
processes in the product life cycle, the project asset life cycle should always be related to the
complete product life cycle in all investment projects.
LCA used for evaluating company products is rather established in many lines of businesses.
But to also include LCA in daily project management is very rare. The most important
features of an LCA consists of the system boundaries (what to include and what not to
include when collecting data). Secondly important is the Functional unit, the unit to which
the data is related to. For process machines, the amount of processed pharmaceutical product
is recommended as Functional Unit, as used in the case study LCA. For other studies the
functional unit has to be carefully chosen. LCA is reactive in its nature, which means that
many decisions already need to be taken in order to finalise the assessment. Instead,
conducted LCAs could guide future decisions regarding product development or new
equipment purchase (Hallstedt et al., 2013).
LCA as a tool is data intensive and time consuming, which often is a limiting factor in
investment projects. Lack of data can also limit the applicability to short-running projects.
Figure 10 suggests various criteria which could initiate a more complete study. According to
this figure, decisions such as industrial transition from traditional industrial processes to
usage of single-use process, also such as batch production and continuous production are
subject to more complete studies. Another alternative would be to compare plasma-derived
47
and recombinant production, using single-use production system vs traditional processing.
All of these alternatives not only consider environmental impacts, but also important
strategic business decisions. As important environmental aspects already are identified at
Octapharma, the weighting function can be used when interpreting LCA result, such as
emphasizing low impact in water use and climate change categories.
In general, there were only a few published LCAs performed in the biopharmaceutical
industry. In basically all of them biopharmaceutical modelling software have been used in
combination with LCA software. Today there are a few free LCA software available, such as
Open LCA (openLCA, n.d.) with several free LCA databases or EcoInvent database (used in
this study) for purchase. Biopharma software such as Aspen Batch plus or Biosolve are most
likely already used at Octapharma and thus the first tool is already well established.
Thinking long-term, an in-house screening tool for internal use in investment projects could
be developed. As suggested by (Jiménez-González & Overcash, 2014) “engineering-based
or design-based assessments” which means that detailed manufacturing data process is
collected and analysed providing a solid foundation for a well-functioning corporate LCI
database. For this purpose, process simulation tools such as Aspen Batch plus or Biosolve
once again are very helpful, in which detailed Bill of Materials are available in the newer
updates (Biopharm, n.d.). Larger investment projects focusing on entire manufacturing lines
is expanding the asset life cycle to product life cycle (see Figure 5). The product life cycle
can be measured in Environmental Product Declarations. One PCR is particularly relevant
for Octapharma, the PCR of blood and blood-derived products for therapeutic or
prophylactic uses, product category classification: UN CPC 35270, 39931. This PCR was
published in December 2016 and one company has published the results of a plasma-based
products (Environdec, 2018a). The PCR specifies system boundaries for how to
environmentally declare a biopharmaceutical product.
5.2.1 Different project types
The case study project examined is a “equipment upgrade project” and therefore many of the
above recommendations are specific. Regarding construction projects the life cycle thinking
is even more long term than the case project in this thesis. Today, the project managers are
using Byggvarubedömningen’s database. As a complement the life cycle of a building can be
modelled using Byggsektorns Miljöberäkningsverktyg. IVL Swedish Environmental
Research Institute has developed Byggsektorns Miljöberäkningsverktyg, a streamlined LCA
tool to manage constructions to comply with Miljöbyggnad 3.0. This, already established
and free of charge tool is aimed to be used by non-LCA professionals and is connected to a
database with average construction data for common materials, transports and usage that can
be replaced with specific EPDs (IVL Svenska Miljöinstitutet, 2018).
5.3 Drivers and LCM value creation The business case and general drivers for sustainability were discussed in the theoretical
background chapter which presented research on sustainability benefits and company value
creation through corporate sustainability, see pt 2.2. Examples of more specific drivers for
sustainability/LCM at Octapharma were identified in the interviews (pt. 4.1). In the
interviews mainly these points were identified:
48
• To plan production capacity and production expansion on an industrial plant with
limited physical space requires resource efficiency and thus sustainability is naturally
included in the need to balance process capacity with expansion of the manufacturing
plant.
• From the environmental manager interview it was evident that investment projects
are based on information. The more information available, the better foundation for
decision-making. Information about environmental impact and future risks and
opportunities are therefore an important pillar in a multi criteria analysis of the
investment.
• Transparency through sustainability reporting in which EPIs such as energy/kg
product and water/kg product will be reported annually, resulting in a natural driver
to improve performance every year.
• Marketing opportunities through external and internal communication of the
corporate sustainability ambitions.
Already today, a life cycle approach is already being practised at Octapharma. It entails a
zero-waste approach using waste as resources; the recycling of ethanol. By installing a
distillation plant onsite Octapharma is reusing the ethanol in the production, reducing the
need for purchasing new ethanol to only 15 % of the site consumption. This investment is a
joint economic and sustainability investment looking at the entire life cycle of the ethanol
production. Business value was created in terms of long-term cost reductions, less transports
on site and operational stability. Increased intangible values were probably work health
aspects for employees, increased employee satisfaction due to sustainability initiative and
less traffic noise for neighbours etc. It is therefore important to include the wide spectra of
both market and non-market values in the analysis of value.
The project sponsor is responsible for clarifying the expected project value in the project
proposal and subsequently the project charter. In the results (pt. 4.2.2) it was suggested to
clarify the project charter template to connect the project value directly to corporate goals,
but also to include other values than economic sustainability. Moreover, the project sponsor
is responsible for supporting the project manager in external stakeholder communication and
lastly reviewing the project in terms of benefits and value actually delivered by the project.
The project manager is responsible for planning the value management throughout the
project and, managing changes in the project in order to analyse whether value is maintained,
but also to encourage team members to report opportunities of increasing project value.
Harbi et al. (2015) point out the importance of stakeholder representation in project teams,
especially the department expecting final value creation.
By including a life cycle approach in the project management model and investment project,
a long-term as well as holistic approach is fulfilled. The long-term life cycle approach is able
to deliver more value in investment projects by extending the value creation timeline far
beyond the end of the project handover. The suggested life cycle approach also adds a
dimension to risk identification by including environmental sustainability risks. Referring to
that 80-90% of a product’s environmental impact is determined at the design stage, i.e. the
project planning phase can mitigate problems already before they are created and thus
49
deliver value. As described in 5.1, the implementation of LCM in investment projects
requires collaboration between many roles, which may enhance stakeholder
management/satisfaction and increase process data collection. Also as suggested in the final
report (pt. 4.2.8) Key Performance Indices and Environmental Performance Indices in each
investment project deliver measurable value and help identify future improvements and
project ideas. In a broader perspective LCM as a management idea is specifically adding a
comprehensive approach to take into account opportunities by not just looking at its own
operations. Once life cycle thinking is established in the company-own operations, the
company value chain should be incorporated. Following the widened perspective value
creation is expanded to include stakeholder satisfaction as a value in itself.
5.4 Limitations of the thesis The aim of the thesis was to present a primary investigation of current status of the technical
project management workflow and the application of an environmental life cycle perspective
to an already finalised project. Therefore, a limitation of the thesis is that it has not been
testing the insights in a real project management situation but applied ideas from a
retrospective perspective. The scope of the thesis was large, and it was difficult to only focus
on investment projects per se, as they cannot be viewed entirely in isolation of the rest of the
company. Especially LCM in investment projects requires organizational aspects to much
the same degree as implementing LCM in the rest of the organization.
As a complement to the LCA study a monetary LCC investigation, in terms of use-phase
expenses, was planned to be included. However, no reliable economic figures could be
retrieved. As a further development of this study, the theoretical results of this study theory
should be applied in practice during a future investment project. An application test bed
starting in a smaller investment project or a smaller part of a larger project is suggested.
The generalizability of this study is somewhat limited as this is a company specific study,
but it could be applied to other companies in the biopharmaceutical industry or companies in
other industrial businesses using the XLPM model as their project management model. This
study contributes with a practical application of LCA to research knowledge.
5.5 Future work Presented in this thesis project management standards lack integration and consideration of
sustainability. Therefore, it is recommended to include sustainability aspects in project
management models such as Project Management Institute’s guideline PMBOK and ISO
21500 as many other project management models are based on both standards.
50
6. Conclusions and recommendations This thesis aimed to bring together project sustainability management and life cycle
management in a biopharmaceutical industry setting. LCAs in different scenarios were
explored and applied to an investment project, suggesting it can be used to compare different
technical solutions.
Below is a general conclusion of important factors to include in a life cycle approach in
investment projects:
▪ Make sustainability part of corporate strategy and targets
▪ Company strategic goals should be reflected at department/section level
▪ Collect and measure baseline values for performance measurement and reporting of
Environmental Performance Indices
▪ Improved internal communication of policies and targets and knowledge sharing in
cross-functional teams.
Interviews from project managers in the biopharmaceutical industry indicated that:
▪ Early integration of sustainability is key
▪ Start off by looking into non-GMP classified buildings and systems
▪ The use of LCA provides the company with more information regarding emissions in
the value chain, resulting in more informed investment decisions and a base for
improvement projects.
From experience of the LCA of two manufacturing technologies it is recommended that:
▪ Start off by using LCC to identify costs in total, thus identifying energy efficient
options.
▪ Have criteria for when to use a small Life Cycle inventory study or a complete LCA
▪ Use bioprocess modelling tools in combination with LCA modelling tools.
51
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Appendix I Below is an overview of the data presented in Table 4 to 9.
Table 10. Modelling categories
Modelling categories Unit Technology A per functional unit
Technology B per functional unit
Stainless steel kg 0,2 0,36
Polypropen kg 0,02 -
Truck*weight Km/kg 35,2 648
Cycle time h 12 12
Media type - Purified Water Filtered steam/compressed air/cooling water
Direct energy consumption kWh 0,0033 0,014
Indirect energy consumption in generating media
kWh 0,0015 0,0072 kWh electricity 0,0048kWh oil
Water consumption l 0,42 0,63
Complete water consumption l 0,60 0,63
Compressed air - 0,0018m3
Cleaning detergent kg 0,0000094 0,00001
Truck*weight Km/kg 28,3 kgkm 46 kgkm
Electricity consumption during steel recycling
0,12kWh 0,2kWh
Polypropene waste management
Incineration
-
Appendix II The interview questions/themes were modified to some extent depending on which project
role that was interviewed.
1. Describe your role in investment projects.
2. How do you work with environmental aspects in project management and investment
projects?
3. What are significant environmental aspects in investment projects?
4. Is there a connection between the project management model and the Octapharma
Stockholm environmental policy?
5. Is there a connection between Octapharma’s significant environmental aspects and
the project management model?
6. As a project manager/buyer/project receiver, where in the investment project phase
would it be wise to consider environmental aspects?
7. What is your previous experience in environmental management and life cycle
thinking/management?
8. Questions about the specific case study
57
Appendix III The Global Reporting initiative 300 environmental standard (GRI, 2018).
GRI 301: Materials
• Disclosure 301-1 Materials used by weight or volume
• Disclosure 301-2 Recycled input materials used
• Disclosure 301-3 Reclaimed products and their packaging material
GRI 302: Energy
• Disclosure 302-1 Energy consumption within the organization
• Disclosure 302-2 Energy consumption outside of the organization
• Disclosure 302-3 Energy intensity
• Disclosure 302-4 Reduction of energy consumption
• Disclosure 302-5 Reductions in energy requirements of products and services
GRI 303: Water and Effluents
• Disclosure 303-1 Interactions with water as a shared resource
• Disclosure 303-2 Management of water discharge-related impacts
• Disclosure 303-3 Water withdrawal
• Disclosure 303-4 Water discharge
• Disclosure 303-5 Water consumption
GRI 304: Biodiversity
• Disclosure 304-1 Operational sites owned, leased, managed in, or adjacent to, protected areas and
areas of high biodiversity value outside protected areas
• Disclosure 304-2 Significant impacts of activities, products, and services on biodiversity
• Disclosure 304-3 Habitats protected or restored
• Disclosure 304-4 IUCN Red List species and national conservation list species with habitats in
areas affected by operations
GRI 305: Emissions
• Disclosure 305-1 Direct (Scope 1) GHG emissions
• Disclosure 305-2 Energy indirect (Scope 2) GHG emissions
• Disclosure 305-3 Other indirect (Scope 3) GHG emissions
• Disclosure 305-4 GHG emissions intensity
• Disclosure 305-5 Reduction of GHG emissions
• Disclosure 305-6 Emissions of ozone-depleting substances (ODS)
• Disclosure 305-7 Nitrogen oxides (NOX), sulfur oxides (SOX), and other significant air emissions
GRI 306: Effluents and Waste
• Disclosure 306-1 Water discharge by quality and destination
• Disclosure 306-2 Waste by type and disposal method
• Disclosure 306-3 Significant spills
• Disclosure 306-4 Transport of hazardous waste
• Disclosure 306-5 Water bodies affected by water discharges and/or runoff
GRI 307: Environmental Compliance
• Disclosure 307-1 Non-compliance with environmental laws and regulations
GRI 308: Supplier Environmental Assessment
• Disclosure 308-1 New suppliers that were screened using environmental criteria
• Disclosure 308-2 Negative environmental impacts in the supply chain and actions taken
58
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