i

ABSTRACT

Design for environment is such an important methodology in discovering the new

product environment that is equivalent in order to fulfill the customers’ needs and wants.

The development of medical product followed by proper design such as considering on

the design for environment can save both environmental and financial resources. This

report proposes the application of principle of Design for Environment (DFE) towards

developing a sustainable product. This concept is applied to consider the environmental

aspects at all stages of the product development process as well as to increase resources

efficiency at all stages of product life cycle ranging from extraction of its material,

manufacturing, packaging, transportation, product usage, and finally to recycling or

disposal of the product. The aims of this report are to strive for products which causes

the lowest possible environmental impact throughout the product life cycle. The

methodology carried out in this report is through analyzing an existing medical product

and implementing DFE tools and guidelines to design a new sustainable product. A

sustainability analysis is conducted concurrently with SolidWorks 2010, to evaluates the

environmental impact of a material throughout the life cycle of a product. Based on the

evaluation of result from sustainable analysis, a new sustainable material of product was

replaced to reduce effect to environment. Lastly, the evaluation and comparison of

environment impact and human health of the existing product and sustainable redesign

product is carried out with the life cycle assessment (LCA) method. The environment

impact is analyzed by mean of SimaPro software which is one of the LCA tools.

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ABSTRAK

Rekabentuk untuk persekitaran merupakan suatu kaedah penting ke arah penemuan

produk persekitaran yang sesuai dan memenuhi keperluan pelanggan. Penghasilan

barangan perubatan diikuti dengan rekabentuk yang bersesuaian seperti

mempertimbangkan rekabentuk untuk yang memenuhi ciri-ciri persekitaran dapat

menyelamatkan alam sekitar serta menjimatkan sumber kewangan. Laporan ini

mencadangkan pengaplikasian konsep dalam rekabentuk untuk persekitaran(DFE) bagi

membangunkan suatu produk yang berterusan. Pengaplikasian konsep ini bertujuan

untuk mempertimbangkan aspek persekitaran pada semua peringkat proses

perkembangan produk dan meningkatkan sumber kecekapan dalam setiap fasa yang

terdapat dalam kitaran jangka hayat produk bermula dari pengekstrakan bahan,

pengeluaran, pembungkusan, pengangkutan, penggunaan produk dan akhirnya untuk

kitar semula atau pelupusan produk. Tujuannya adalah untuk mengusahakan produk-

produk yang memberikan kesan persekitaran yang serendah mungkin sepanjang kitaran

hidup produk. Kaedah yang dilakukan dalam laporan ini adalah mengembangkan produk

yang sedia dan menerapkan alat DFE dan panduan untuk merekabentuk produk baru

yang berterusan. Analisis yang berterusan dilakukan bersamaan dengan SolidWorks

2010, untuk menilai kesan persekitaran dari suatu bahan sepanjang kitaran hidup produk.

Berdasarkan penilaian hasil dari analisis yang berterusan, bahan berterusan produk baru

diganti untuk mengurangkan kesan terhadap alam sekitar. Akhirnya, penilaian dan

perbandingan kesan persekitaran dan kesihatan manusia terhadap produk sedia ada dan

produk baru yang melibatkan lestari dilakukan dengan penilaian kitaran hidup (LCA).

Kesan persekitaran ini dianalisis oleh perisian SimaPro yang mana ia merupakan salah

satu daripada kaedah LCA yang digunakan secara meluas.

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ACKNOWLEDGEMENT

A deep sense of thankfulness to Allah who has given me the strength, ability and

patience to complete this project as it is today. Firstly, I would like to take this

opportunity to put into words my deepest gratitude and appreciation to the Project

Supervisor, En. Tajul Ariffin Bin Abdullah for his supports, guidance, patience,

encouragement and abundance of ideas during the completion of this project. Secondly,

special thanks to honorable panels, En. Hassan Bin Attan and En. Taufik for their

comments, invaluable suggestions and outstanding deliberations to improve the project

during the project presentation. I would also like to express my extraordinary

appreciation to my family for their invaluable support along the duration of my studies

until the completion of Final Year Project. Finally yet importantly, thanks to all the

persons who are directly or indirectly contributed especially to my friends because their

perspective and guidance helped greatly to point me in the right direction until the

completion of this project.

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TABLE OF CONTENTS

TITLE PAGE

Abstract i

Acknowledgement iii

Table of Contents iv

List of Figure viii

List of table x

List Abbreviations xi

CHAPTER1: INTRODUCTION

1.0 Background 1

1.1 Objective 2

1.2 Scope 2

1.3 Problem Statement 3

1.4 Thesis Organization 4

CHAPTER 2: LITERATURE REVIEW

2.0 Introduction 5

2.1 Design for Environment 5

2.1.1 Objective of DFE 7

2.1.2 Approaches to optimal environment performance 8

2.1.3 The new DfE Process 9

2.1.4 DFE benefits 11

2.1.5 Analysis of DfE Process/ DfE Tools 11

2.1.5.1 Guidelines and Checklist Document 12

2.1.5.2 Use of Flow Charts 13

2.1.5.3 Use of Matrices 14

2.1.5.4 Life-Cycle Assessment (LCA) 15

v

2.1.5.5 Environment Conscious Quality Function Deployment 17

2.2 Design for disassembly (DfD) 18

2.3 Design for Recycling and Reused 20

2.4 Green technology 21

2.5 Green manufacturing 23

2.6 Sustainability 24

2.6.1 Design 24

2.6.2 Design for Sustainability 25

2.6.3 Implementing sustainable design 26

2.6.4 Barriers to Sustainability 27

2.6.5 Concepts and Tools for Sustainable Design 28

2.6.5.1 Closed-loop or Closed-cycle Design 28

2.6.5.2 Life-cycle Analysis (LCA) 28

2.6.5.3 Sustainable Manufacturing 29

2.6.5.4 Sustainable Manufacturing Standards 30

2.7 Environmentally Responsible Product Development 31

2.7.1 Decision Production Systems 32

2.8 Conceptualizing a Medical Need 33

2.9 Material selection 34

2.9.1 PVC 35

2.9.1.1 PVC in medical items 35

2.9.2 Polycarbonate 37

2.9.2.1 Medical Applications 38

2.10 Dialysis 39

CHAPTER 3: METHODOLOGY

3.0 Introduction 41

3.1 Process Flow Chart 41

3.1.1 Identify the Project Title 43

3.1.2 Define Background, Problem Statement, Objective and Scope 43

3.1.3 Develop Literature Review 44

vi

3.1.4 Design Methodology for Structural Analysis 44

3.1.5 Result and Discussion 45

3.1.6 Conclusion and recommendation 45

3.1.7 Report Writing and Submission 45

3.2 Phases of DFE Analysis 46

3.2.1 Analyzing of Product (Sustainability analysis) 47

3.2.1.1 DFE Analysis Flow 47

3.2.1.2 Environmental Impact 48

3.2.2 Assessment of environmental performance 49

CHAPTER 4: RESULT AND DISCUSSION

4.1 Introduction 51

4.2 Current product 51

4.2.1 Product Specification 52

4.2.2 Exploded view 53

4.3 Material Analysis on dialyzer Product 53

4.3.1 Case part analysis 54

4.3.2 Cap part analysis 55

4.3.3 End caps part analysis 56

4.4 Material Selection for Sustainable Product 58

4.5 Material Choice for Sustainable dialyzer 62

4.5.1 Sustainable Product Part 67

4.5.1.1 Case/body 67

4.5.1.2 End caps 72

4.5.1.3 Cap 76

4.5.2 Summary for sustainable dialyzer 81

4.6 Life Cycle Assessment (LCA) 81

4.6.1 Life Cycle Assessment of HDPE dialyzer 83

4.6.2 Life Cycle Assessment of Polycarbonate dialyzer without reused 84

4.6.3 Comparison of Life Cycle Assessment of PC dialyzer and

HDPE dialyzer 85

vii

4.6.4 Life Cycle Assessment of Polycarbonate dialyzer with reused 87

4.6.5 Comparison of Life Cycle Assessment of PC dialyzer

and PC dialyzer reused 89

4.7 Sustainable design and material of dialyzer 94

CHAPTER 5: CONCLUSION AND RECOMMENDATION

5.1 Conclusion 97

5.2 Recommendation 98

REFERENCE 99

APPENDICE A

APPENDICE B

APPENDICE C

viii

LIST OF FIGURES

1.1 Article San Francisco Chronicle 3

2.1 Objective and Characteristics of DFE 7

2.2 Main phases of product life cycle and flow of recourses 8

2.3 Combined Safety and Environmental Review Process 10

2.4 Example DfE checklist question 12

2.5 Example of flow chart questions 14

2.6 Product design matrix 15

2.7 Life Cycle Approach as basis for modeling systems 16

2.8 DfE flow and design support tools 18

2.9 Green technology subject areas 22

2.10 The Shift to Sustainable Design 24

2.11 Sustainability and the Design Funnel 25

2.12 Relationship between sustainable development, sustainability,

and green engineering 26

2.13 Product development organization with isolated environmental

decision-making 33

2.14 Design of this safety syringe allows healthcare practitioners

to operate the device with one hand. 35

2.15 Polycarbonate resin 37

2.16 Dialyzer 39

2.17 Hemodialysis schematic 40

3.1 Process flow in conducting PSM 1 & PSM 2 42

3.2 Phases of analysis 46

3.3 Process flow in conducting sustainability analysis 47

3.4 Pie chart 48

3.5 Comparisons bars 48

ix

3.6 Powerful analytical features on many levels 49

3.7 Interactive analysis of a network 50

3.8 Comparison (damage assessment) analysis of a human health,

ecosystem quality and resources 50

4.1 Dialyzer 52

4.2 Exploded view of dialyzer 53

4.3 The graph analyze view of Case 54

4.4 The graph analyze view of Cap 55

4.5 The graph analyze view of End cap 56

4.6 Pie Chart Environmental Impact of ABS case 68

4.7 Pie Chart Environmental Impact of PC case 69

4.8 Pie Chart Environmental Impact of HDPE case 70

4.9 Pie Chart Environmental Impact of ABS end caps 73

4.10 Pie Chart Environmental Impact of PE High Density end caps 74

4.11 Pie Chart Environmental Impact of HDPE cap 77

4.12 Pie Chart Environmental Impact of PP cap 78

4.13 Pie Chart Environmental Impact of PC cap 79

4.14 Tree Diagram of HDPE dialyzer 83

4.15 Tree Diagram of PC dialyzer without reused 84

4.16 Comparison PC dialyzer and HDPE dialyzer (weighting) 85

4.17 Comparison PC dialyzer and HDPE dialyzer (single score) 86

4.18 Tree diagram of PC dialyzer reused 88

4.19 Comparison PC dialyzer and PC dialyzer reused (weighting) 89

4.20 Comparison PC dialyzer and PC dialyzer reused (single score) 90

4.21 Solid Waste Management Hierarchy 91

4.22 Comparison HDPE, PC and PC dialyzer reused (damage assessment) 91

4.23 Impact strength of commonly sold plastics. 93

4.24 Comparison HDPE, PC and PC dialyzer reused (single score) 94

4.25 Sustainable dialyzer (PC reused) 96

x

LIST OF TABLES

3.1 Descriptions of the ECQFD structure 63

4.1 Summary of the result from XRD 57

4.2 Plastics Comparison & Selection Guide 59

4.3 Data Sheets Properties for Thermoplastic 61

4.4 Current material and target sustainable properties of case and end caps 62

4.5 Current material and target sustainable properties of cap 63

4.6 Summary of Case Sustainability Results on Environment Impact 71

4.7 Summary of End Caps Sustainability Results on Environment Impact 75

4.8 Summary of Cap Sustainability Results on Environment Impact 80

4.9 Summary of Sustainability Analysis in SolidWork 2010 on dialyzer 81

4.10 Material and disposal each component of sustainability dialyzer 95

xi

LIST OF ABBREVIATIONS, SYMBOLS, SPECIALIZED

NOMENCLATURE

ABS - Acrylonitrile butadiene styrene

CML - Centre of Environmental Sciences at Leiden University

Cu - Copper

DEHP - Di-(2-ethylhexyl) phthalate

DFA - Design for Assembly

DfD - Design for disassembly

DfE - Design for Environment

ECQFD - Environmentally Conscious Quality Function Deployment

EEA - Assessment or Environmental Effect Analysis

EIO-LCA - Economic Input-Output LCA

EM - Engineering Metrics

EMS - Environmental Management System

EPA - Environmental Protection Agency

ERPD - Environmentally Responsible Product Development

EtO - Ethylene Oxide

FDA - food and Drug Administration

GWP - Global Warming Potential

HDPE - Polyethylene High Density

ISO - International Organization for Standardization

JEMAI - Japan Environmental Management Association for Industry

QFDE - Quality Function Deployment for Environment

KG - Kilogram

LCA - Life Cycle Assessment

xii

LDHE - Polyethylene Low Density

MJ - megajoules

N - Nitrogen

OEM - Original Equipment Manufacturer

OHSAS - Occupational Health & Safety Advisory Services

PB-EMS - Product-based Environmental Management Systems

PC - Polycarbonate

PE - Polyethylene

PP - Polypropylene

PVC - Polyvinyl chloride or vinyl

TDI - Tolerable Daily Intake

TRACI - Tool for the Reduction and Assessment of Chemical

VOC - Voice of Customer

XRD - X-ray diffraction

1

CHAPTER 1

INTRODUCTION

1.0 Background

Design is key to the function, meaning, and appeal of products used by people

every day throughout the world (Kurk F. et al., 2004). It has been recognized as a

critical stage for determining costs and profitability. The National Research Council

estimates that 70 percent or more of the costs of product development, manufacture, and

use are determined during initial design stages (Kurk F. et al., 2004). For those who

bring shape to our physical world by designing products, it is also an unparalleled

window of opportunity to distinguish products, while championing the environment

through innovation.

Exactly what draws consumers to pick up a product or just to want it is

sometimes referred to as “Factor X.” While this factor can be elusive, a common

element of good design is satisfaction of the core needs of the user. Hence meeting these

needs with unique, will assists in improving the design as well as to differentiate

products in the marketplace.

Manufacturers started thinking in terms of "design for" qualities or traits in their

products and processes. At the same time, views on risk management began shifting to

approaches that promote risk reduction through pollution prevention (also known as

source reduction). Environmental Protection Agency (EPA) recognized the need to

develop a cleaner, safer technologies program to work with industry to design products,

processes, and technologies that are competitive but environmentally preferable

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(www.epa.gov/). Several non-regulatory, voluntary initiatives on safer chemical

synthesis, comparative risk analysis, and alternative technology development merged to

create the EPA's Design for Environment (DfE).

1.1 Objectives

The objectives of this study are:

1) To investigate the design parameters of medical product.

2) To analyze the medical product using Design for Environment analysis.

3) To purpose the medical product base on Life Cycle Assessment.

1.2 Scope

The scope of this study is to focus on analyzing medical product based on DFE

guidelines, methods, and tools obtained through the literature studies. This research also

includes the environmental impact and performance of the product evaluated with

Solidwords (Student Vision) and SimaPro which is this software for LCA studies. As for

the boundary, the analyses only cover the external feature of the dialyzer (case, end cap,

and cap).

1.3 Problem Statement

When a product is designed and introduce to the market, the value of the

environmental of product is given less priority and this has lead to lack of environmental

friendly product in market. Every such product in the market will eventually face the

risk of disposal difficulties at the end of the products life. Hence, this led to the raised of

a product cost due to the disposal difficulties. Usually, Hospitals generate more than two

million tons of waste each year (http://www.noharm.org/us/). In the past, many hospitals

3

simply dumped all waste streams together, from reception-area trash to operating-room

waste, and burned them in incinerators. Incineration is a leading source of highly toxic

dioxin, mercury, lead and other dangerous air pollutants such as in Article San Francisco

Chronicle showed in figure 1.1.

Figure 1.1: Article San Francisco Chronicle

(Source: This article appeared in the San Francisco Chronicle on June 9, 2005)

Environmental concern for the use of disposable healthcare products has

continued to escalate over the past ten years. Medical waste is substantial and must be

considered in the overall health of the population. Over the past decade, the mortality of

dialysis patients has steadily decreased while dialyzer reuse has increased steadily

during this time becoming the major sterilant used in 56% of the 82% of centers that

reprocess dialyzers in the United States (Steven G.,2000). The reprocessing of dialyzers

has economic benefits as well improved patient benefits which have legitimatized the

practice of dialyzer reuse. However, there are substantial benefits to the environment

which also result from the practice of dialyzer reuse. reprocessing of dialyzers has led to

the elimination of millions of pounds dialyzer waste and is recommended for facilities

which are not practicing dialyzer reprocessing.

4

This project will look into implementation of DFE method and tools to obtain a

sustainable product that will have less impact on the environment and human health than

current product.

1.4 Thesis Organization

This thesis consists of five chapters. In chapter 1, the background and problem statement

of the research are described. It also states the objectives of the research as well as the

scope and limitation of study and also organization of thesis.

In chapter 2, a Literature review of the research topic is conducted. The study on the

Design for Environment principles. Besides that, the study on tool of DFE relate on

product and anything that helps in the study is also stated in this chapter.

In chapter 3, the methodology of the research is presented. Methods or any particular

procedures used to complete the analysis are noted in this chapter. It also includes the

chronology of the research.

In chapter 4, the results of analysis are discussed. This chapter is a very important part of

this thesis and finally, the conclusions and recommendations are stated in chapter 5.

5

CHAPTER 2

LITERATURE REVIEW

2.0 Introduction

This chapter presents the literature search was performed to study, implement,

design and analyze the sustainable product through implementation of Design for

Environment (DfE). The study also includes the areas of product material, product

design and development of sustainable product. All the information that were collected

are very important to ensure that the project research achieved the objective.

2.1 Design for Environment

The first consideration of the technical aspect associated with the practice of a

design action directed at reducing the environment impact of product appeared in the

first half of the 1980s (Overby, 1979). In the early 1990s, these first experiences were

followed by a phase of greater understanding of a new need to safeguard resources,

which consolidated in a wide diffusion of a new ideas and experiences developed with

the clear objective of integrating environment demands in traditional design procedures

(Navin-Chandra, 1991). In this way a new approach to the design intervention was born,

know as Design for Environment (DfE), characterized by the priority objective of

already in the design phase, minimizing the impact of product on the environment.

From the life-cycle perspective, designers gain inherent drivers for improving

design. Materials tend to be selected more prudently and used more efficiently.

6

Consideration of alternative materials or sources of energy is built into the design

process. The result could be an ingenious connector design or use of a small fuel cell for

energy.

Design for Environment (DfE) surprisingly coincides very well with design for

manufacturability. With DfE, a lot of components and pieces of the hardware that snap

together or can come apart easily and that also benefits our manufacturing assembly time

as well as the throughput rate of all of our products on the production floor. So not only

do we get the environmental benefits, but we get the manufacturing benefits at the same

time.

Another source states that Design for Environment (DfE) is an attempt taken to

minimize the environmental impact of the product during its life cycle ranging from

extraction of raw material through processing, manufacturing and transportation to

reuse, recycling, and final disposal in order to decrease the consumption of raw material

and energy, reduce cost and make process environment friendly (Anastassia M. et al.,

2005).

Design for Environment also primarily refers to product related environmental

care, diminishing environmental effects of a product before it is produced, distributed

and used. DFE examines the disassembly of products at the end-of-life and reveals the

associated cost benefits and environmental impact of , reuse and recycling.

Furthermore Design for Environment (DfE) Programme helps businesses

incorporate environmental considerations into the design and redesign of products,

processes, and technical and management systems. Initiated by US Environmental

Protection Agency's (EPA's) Office of Pollution Prevention and Toxics (OPPT) in 1992,

DFE forms voluntary partnerships with industry, universities, research institutions,

public interest groups, and other government agencies.

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2.1.1 Objective of DFE

The objective is to minimize or eliminate, during design, the anticipated waste

generation and resource consumption in all subsequent life cycle phases: construction,

operation, and closure (or production, use, and disposal). In addition to its specific

primary objective and its orientation toward the cycle, DFE is characterized by two other

aspects as shown in figure 2.1 particular:

The dual level of intervention, regarding both products and processes

The proactive action of intervention, base on the presupposition of the greater

efficacy of intervening early in the product development process (i.e., in the early

design phases).

Figure 2.1: Objective and characteristics of DFE

(Source: Giudice, F. ,2006.pg-17)

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PRODUCTION

DISPOSAL

RAW MATERIAL

USE REMANUFACTURE

RECYCLE REUSE

2.1.2 Approaches to optimal environment performance

The central theme unifying the various studies of DFE can be identified in the

common objective of reducing the environment impact of a product over its entire life

cycle, from design to disposal (Coulter et al., 1995). The concept of “reduction of

environment impact” is not, however, limited to the simple quantification and

minimization of direct impact on the ecosystem. Rather, in this context it has to be

understood in wider terms, as the optimization of environment performance, which

include a more articulated range of aspect:

Reduction of scrap and waste, allowing a more efficient use of resources and a

decrease in the volumes of refuse, and, more generally, are reduction in the

impact associated with the management of waste material.

Optimal management of material, consisting of the correct use of material on the

basis of the performance require, in their recovery at the end of the product‟s life

and in the reduction of toxic or polluting material.

Optimization of the production processes, consisting of planning of processes

that are energetically efficient and result in limited emissions.

Improvement of the product, with particular regard to its behavior during the

phase of use, to reduce the consumption of resources or the need for additional

recourses during its operation.

Figure 2.2: Main phases of product life cycle and flow of recourses

(Source: Giudice, F. ,2006.pg-19)