An Analysis Of RF Radiation Exposure On Biological Pharmaceuticals For RF Applications.

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AN ANALYSIS OF RF RADIATION EXPOSURE ON BIOLOGICAL PHARMACEUTICALS FOR RF APPLICATIONS

Mohan S/O Sinnappa

This Report Is Submitted In Partial Fulfilment Of Requirement For The Bachelor Degree of for Electronic Engineering (Wireless Communication)

Faculty of Faculty of Electronic and Computer Engineering Universiti Teknikal Malaysia Melaka

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UNIVERSTI TEKNIKAL MALAYSIA MELAKA

FAKULTI KEJURUTERAAN ELEKTRONIK DAN KEJURUTERAAN KOMPUTER

BORANG PENGESAHAN STATUS LAPORAN PROJEK SARJANA MUDA II

Tajuk Projek : AN ANALYSIS OF RF RADIATION EXPOSURE ON _{BIOLOGICAL PHARMACEUTICALS FOR RF APPLICATIONS} Sesi

Pengajian : SESI 2011/2012

Saya MOHAN A/L SINNAPPA mengaku membenarkan Laporan Projek Sarjana Muda ini disimpan di Perpustakaan dengan syarat-syarat kegunaan seperti berikut:

1. Laporan adalah hakmilik Universiti Teknikal Malaysia Melaka.

2. Perpustakaan dibenarkan membuat salinan untuk tujuan pengajian sahaja.

3. Perpustakaan dibenarkan membuat salinan laporan ini sebagai bahan pertukaran antara institusi pengajian tinggi.

4. Sila tandakan ( √ ) :

SULIT*

*(Mengandungi maklumat yang berdarjah keselamatan atau kepentingan Malaysia seperti yang termaktub di dalam AKTA RAHSIA RASMI 1972)

TERHAD** **(Mengandungi maklumat terhad yang telah ditentukan oleh organisasi/badan di mana penyelidikan dijalankan)

TIDAK TERHAD

Disahkan oleh:

__________________________ ___________________________________ (MOHAN A/L SINNAPPA)

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iii

“I hereby declare that this is the results of my own paper except for quotes as cited in the references.”

Signature :

Author : MOHAN S/O SINNAPPA Date : 15TH_{JUN 2012}

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“I hereby declare that I have read this report and in my opinion this report is sufficient in terms of the scope and quality for the award of Bachelor Degree of Electronic and Computer Engineering (Wireless Communications) with Honours.”

Signature :

Supervisor’s Name : MR. MOHD AZLISHAH BIN OTHMAN Date : 15TH_{JUN 2012}

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This project and research work is dedicated to any beloved parents for their devoted caring throughout my life, my loving brother and sister, also my friends for their

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ACKNOWLEGDEMENT

First and foremost, I want to thanks the god because without his grace I will not able to complete this Final Year Project (FYP) and report for the session 2012 as well as possible. Here, I would like to thank my University Teknikal Malaysia Melaka (UTeM) coordinator/supervisor Sir. Mohd Azlishah Bin Othman and Sir. Mohamad Zoinol Abidin Bin Abdul Aziz, who advice and guide me to complete the Final Year Project and report in time. During to complete this Final Year Project (FYP) and report, I face lots of problems and difficulties. However, I manage to crossed it all with patience and complete it properly. The journey in completing Final Year Project (FYP) and report really teach me in terms of leadership, proper time management, communication skill, technical knowledge, soft skill and so many more. The advice and encouragement from supervisor is really motivating me to do the best. In addition, my family members and friends also became a part of in completing the Final Year Project (FYP) and report, which help me in giving some rational idea and supports. Finally, I would like to thank those involved directly and indirectly in completing the Final Year Project (FYP) and report successfully. Thank very much to you all.

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ABSTRACT

This Final Year Project (FYP) refers to technical work and report writing experience that is relevant to professional development prior to graduation. One of the Universiti Teknikal Malaysia Melaka requirements for the award of Bachelor of Electronic Engineering (Wireless Communication) is that a student should complete his/her Final Year Project (FYP) and report. In order to that, my Final Year Project (FYP) titled “An Analysis of Radio Frequency (RF) Radiation Exposure on Biological Pharmaceuticals for RF Application”. Radio Frequency (RF) radiation or Electromagnetic radiation (EMR) is a form of energy exists in wave form which travels through free space. Biopharmaceuticals define as pharmaceuticals biological in nature and manufactured using biotechnology. Mean while drugs comprise the other major subset of pharmaceuticals, with their source and manufacture being chemical in nature. The purpose of analyzing the RF radiation exposure on biological pharmaceuticals for RF application is to study on RF radiation, analysed the characterized of RF radiation exposure and experimental the implication of RF radiation on biological pharmaceuticals for RF application. The methods to conduct this project need lots of literature review based on past studies and experimental which have been conducted, and required a well understanding and knowledge in RF radiation on biological pharmaceuticals for RF application. Then, continue with the test setup which needs to generate and radiate the high power RF signal at different frequency inside modified anechoic chamber which the product is exposed to RF radiation. There are five common frequencies specified to generate RF radiation with Federal Communications Commission (FCC) guide line. All the experiment results are recorded and this information will use in analyzing and investigation the effect on purity and potential stable integrity went RF radiation exposure on biological pharmaceuticals for RF application.

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ABSTRAK

Projeck Sarjana Muda (PSM) adalah satu usaha dalam menanaman dan pembagunan sifat professional yang berasaakan kerja-kerja teknikal dan softskill secara menyeluruh. Salah satu syarat untuk melengkapkan penganugerahan Ijazah Sarjana Muda Kejuruteraan Elektronik (Komunikasi Wayar), Universiti Teknikal Malaysia Melaka, seseorang mahasiswa perlu melengkapkan secara menyeluruh berkaitan Projek Sarjana Muda dengan sempurna. Berasaskan tujuan dan matlamat itu, Projeck Sarjana Muda (PSM) saya bertajuk “Analisis Pendedahan Sinaran frekuensi Radio (RF) keatas Biologikal Pharmaseutikal didalam pengapplikasi frekuensi Radio (RF). Frekuensi Radio (RF) atau sinaran elektromagnet (EMR) adalah satu bentuk tenaga wujud dalam bentuk gelombang yang bergerak melalui rawak di ruang bebas. Biofarmaseutikal ditakrikan sebagai bahan ubat-ubatan yang dihasil secara semulajadi melalui pemprosesan bioteknilogi. Selain itu, bahan dadah adalah sample tambahan sampingan selain bahn kimia buatan semulajadi. Tujuan utama kerja menganalisis pendedahan sinaran RF terhadap sample biofarmaseutikal adalah untuk mengkaji dan mempelajari ciri-ciri serta implikasi radiasi RF terhadap biologi farmaseutikal didalam pengaplikasian RF. Untuk memudahkan kerja PSM ini, perkara asas ialah pencarian sumber maklumat dan informasi yang kukuh bagi memudahkan pemahaman dan penambahan pengetahuan yang asas. Selain itu, perancangan dan persedian awal dari segi perkakasan dan perisian kerja PSM perlu dirancang dan dilaksanakan secara teliti dan berkesan. Pelarasan keatas frekuensi RF yang dipancarkan melalui antenna horn kedalam kotak anechoic dan ia diterdedah keatas sample ubat. Semua keputusan dan data direkodkan serta akan digunakan dalam menganalisa dan penyiasatan pendedahan sinaran frekuensi Radio (RF) keatas Biologikal Pharmaseutikal didalam pengapplikasi frekuensi Radio (RF).

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TABLE OF CONTENT

CHAPTER TOPIC PAGES

PROJECT TITLE i

REPORT VERIFICATION STATUS FORM ii

DECLARATION iii

SUPERVISOR DECLARATION iv

DEDICATION v

ACKNOWLEDGEMENT vi

ABSTRACT vii

ABSTRAK viii

TABLE OF CONTENT ix-xi

LIST OF FIGURES xii-xiii

LIST OF TABLES xiv

LIST OF ABBREVIATIONS xv

I INTRODUCTION

1.1 Background 1 - 4

1.2 Problem Statement 4

1.3 Objectives 5

1.4 Scope 5

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2 LITERATURE REVIEW

2.1 Introduction 8 - 9

2.2 Food & Drug Administration 9 - 10

2.3 Radiation Test 10

2.4 Hardware Setups 11-12

2.5 Anechoic Chamber 12-13

2.6 Power & EIRP 14-16

2.7 MATLAB & ADS Software 16-18

3 METHODOLOGY

3.1 Introduction 19

3.2 Overall Project Methodology 20

3.3 Project Experiment Methodology 21-22

3.4 Project Setup 23-25

3.5 Planning & Milestones 25-26

3.6 Gantt Chart 27

4 RESULTS & DISCUSSION

4.1 Introduction 28

4.2 Works 29

4.3 Raw Data 29-30

4.4 Losses Subtraction & Compile 30-31

4.5 Matlab Simulation 31-34

4.6 Matlab Codings 34-35

4.7 3D Results & Discussions 36-41

5 CONCLUSION

5.1 Introduction 42

5.2 Conclusions 42-43

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xi 5.4 System & Potential Applications 44

5.5 Benefit of Applications 45

5.6 Achievements in Competitions 45-46

REFERENCES 47-50

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xii

LIST OF FIGURES

NO TOPIC PAGES

2.1 Hardware setup to generate RF signal radiation 11

2.2 Inter setup of anechoic chamber 12

2.3 The isometric view of design RF lucent table 13

2.4 Radial distance beyond which the 14

2.5 EIRP Formula 15

2.6 Changes in temperature biological pharmaceuticals sample 15

2.7 3D results from Matlab 16

2.8 ADS 2010 and MATLAB version 7 17

3.1 Project Methodology 20

3.2 Project Experiment Methodology 21

3.3 Design of modified anechoic chamber 22

3.4 The hardware and software setup 23

3.5 Real setup and testing 24-25

4.1 Raw data S11 parameter from VNA 29

4.2 Chiorpheramine for mol 40ml at different distance 30 4.3 Average of 10th_{degree Polynomial for Chiorpheniramine with}

distance 5cm at 50ml 31

4.4 Average of 10th degree Polynomial for Chiorpheniramine with

distance 5cm without mixed mol 32

4.5 Average of 10th degree Polynomial for Chiorpheniramine with

distance 35cm without mixed mol 32

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xiii

distance 35cm At 40ml mixed mol 33

4.7 Average of 10th degree Polynomial for Chiorpheniramine with

distance 35cm At 50ml mixed mol 33

4.8 Matlab codings of sample Chiorpheniramine with distance fixed

at different mol 34

4.9 Matlab codings of sample Chiorpheniramine with mol fixed

at different distance 35

4.10 Sample Chlorpheniramine with distance 5 Centimeter (cm) at

different mol 37

4.11 Sample Chlorpheniramine with distance 10 Centimeter (cm) at

different mol 38

4.12 Sample Chlorpheniramine with distance 15 Centimeter (cm) at

different mol 40

5.1 System and potential application 44

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xiv

LIST OF TABLES

NO TOPIC PAGES

3.1 Milestone and dates 24

3.2 Gantt chart 25

4.1 S11 parameter in decibel for the five type frequency at sample Chlorpheniramine with fixed distance 5 Centimeter (cm) and

varied at different mol 38

4.2 S11 parameter in decibel for the five type frequency at sample Chlorpheniramine with fixed distance 10 Centimeter (cm) and

varied at different mol 39

4.3 S11 parameter in decibel for the five type frequency at sample Chlorpheniramine with fixed distance 15 Centimeter (cm) and

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LIST OF ABBREVIATIONS

RF - Radio Frequency

UTeM - Universiti Teknikal Malaysia Melaka FYP - Final Year Project

IEEE - Institute of Electrical and Electronics Engineers RFID - Radio Frequency Identification

EM - Electromagnetic

EMR - Electromagnetic Radiation

EIRP - Equivalent Isotropic Radiated Power FCC - Federal Communications Commission FDA - Food and Drug Administration

CDRH - Centre for Devices and Radiological Health BLA - Biologics License Application

NDA - New Drug Application UPC - Universal Product Code EPC - Electronic Product Code NRZ - Non Return Zero

DC - Direct Current Pt - Power Transmitted Lc - Cable Loss

Ga - Antenna Gain

DBi - Decibel over Isotropic Sa - Spectrum Analyzer ADS - Advanced Design System VNA - Vector Network Analyzer SMA - Sub Miniature version A

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CHAPTER 1

INTRODUCTION

1.1 Background

Radio Frequency (RF) has been applied over past decade in many application systems and its emerging technology in this modern world [1]. The RF is allocated at the rage of 3kHz to 300GHz spectrum bandwidth. By history, the application of RF is not only in telecommunication and broadcasting field, but it tremendously increase in various fields such as in an industries, science and medical field. Thus, RF radiation expose in an environmental is possible. Radio Frequency (RF) radiation or Electromagnetic radiation (EMR) is a form of energy exists in wave form which travels through free space [10].

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Biopharmaceuticals define as pharmaceuticals biological in nature and manufactured using biotechnology. Mean while drugs comprise the other major subset of pharmaceuticals, with their source and manufacture being chemical in nature [11]. The purpose of analyzing the RF radiation exposure on biological pharmaceuticals for RF application is to study on RF radiation, analyzed the characterized of RF radiation exposure and experimental the implication of RF radiation on biological pharmaceuticals for RF application.

The methods to conduct this project need lots of literature review based on past studies and experimental which have been conducted, and required a well understanding and knowledge in RF radiation on biological pharmaceuticals for RF application. Then, continue with the test setup which needs to generate and radiate the high power RF signal at different frequency inside temperature and light sensitivity controlled dark anechoic chamber which the product is exposed to RF radiation. There are five common frequencies specified using eight Watts of the Equivalent Isotropic Radiated Power (EIRP) to generate RF radiation with Federal Communications Commission (FCC) guide line. Then it is exposure for twenty four hours continuously to test on pharmaceutical compound that use as a medicinal drug product under three main protein groups accordingly. All the experiment results are recorded and this information will use in analyzing and investigation the effect on purity and potential stable integrity went RF radiation exposure on biological pharmaceuticals for RF application. The Food and Drug Administration (FDA) at United States is responsible for protect and promoting public health by regulation and supervision on food safety, dietary supplements, medications, vaccines, biopharmaceuticals, electromagnetic radiation devices and many more. The Centre for Devices and Radiological Health (CDRH) is one of branch under United States Food and Drug Administration (FDA) where it responsible on premarket approval of medicine device and overseeing manufacturing, performance and safety of devices. The CDRH also responsible for the radiation safety performance of non medical devices which emit certain range electromagnetic radiation. FDA not allows drugs covered

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under Biologics License Application (BLA) and New Drug Application (NDA) [2]. Mean while, have a lots of encourage future research involve RF application such as Radio Frequency Identification (RFID) due to insufficient information about potential impact of RF on biologics. The RF application used to track and trace on number or code, and maintain supply chain visibility of products.

By history, the RFID system is replacing the bar code technology which has been using past years [6]. The type of bar codes system in RFID is effective which applied the Universal Product Code (UPC) for unique individual items compare to the Electronic Product Code (EPC) for unique to product. The RFID system gets the information from ID and dates which provide more information in real time and sensor temperature sensitive products entirely. The information is valuable in term of product shipment and the product in market based on current real time e-pedigree which can prevent missed used or food and drugs. The RF radiation can analyze in term of temperature and frequency combination. The thermal effect arise from noticeable change in temperature which comparable to conventional heating. The product heating factors may due to frequency of EM source, dielectric constant, content of water and the thickness of products [3,7]. The product and substance greater in conductivity absorb greater amount of radiation which turn generates more heat. Studies have shown that environmental levels of RF energy routinely encountered by the general public are far below levels necessary to produce significant heating and increased body temperature [29 -34].

By that, the test carried on specified five common RF such as 13.56MHz, 433MHz, 868MHz, 915MHz and 2.4GHz where it is commercial frequency applied in biological pharmaceuticals for RF application [21]. On other hand, the most common pharmaceutical compound manufacture was identify for use as a medicinal drug product under three main protein groups such as Vaccines, Hormones and Immunoglobulin. According to five different frequency with using eight Watts of the equivalent isotropic radiated power (EIRP) is used to exposed RF radiation to test the three main protein groups as plan for twenty four hours continuously. The EIRP is used in experiment is

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The most recent and most intense public concern stems from both the passage of Radiation Control for Health and Safety Act of 1968 [14,15], and the increasing sales of Microwave ovens [16]. There is considerable data on hemoglobin solution and whole blood, some data skin, and some interest in cellular effects [17, 18]. Ultraviolet irradiation has been subjected of interest for many years due to the hazarders involved [19, 20].

1.2 Problem Statement

As the time passed, lots of technology and development take placed to provide more convenience environment that suite that generation entirely. Ones of these impacts are in wireless communication system specifically in Radio Frequency (RF) system. The RF application was applied in many fields such as military, hospitality and healthcare, industrial area, transportation and logistics, sports, commercial purpose and so on. Similarly to that, the RF was applied in science and medical especially in biological and pharmaceuticals such as Radio Frequency Identification (RFID), medical diathermy machines and many more. The problems that I found in RF application in biological and pharmaceuticals such as tables form is, an insufficient data sheets in effects of RF radiation exposure on biological pharmaceuticals for RF application. Based on that reasons, I doing this project to support and provide some data based on my experiment on few biological and pharmaceutical samples.

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1.3 Objectives

This study embarks on the following objectives: i. To study the RF application and RF radiation.

ii. To develop experiment to characterize on RF Radiation Exposure. iii. To analyze of RF Radiation Exposure on Biological Pharmaceuticals.

1.4 Scope

The scope of this study will cover the analysis of RF radiation exposure on biological pharmaceuticals for RF application. The RF radiation will generates on few fixed frequency, where it is the most applied frequencies in biological and pharmaceutical for RF application. Beside that’s, the most commons biological pharmaceutical samples will choose and tested, where the tablets samples in powdered form. The effects of RF radiation on biological pharmaceuticals for RF application will test in term of frequency, power and the return loss parameters. Further study will carry out if the listed scopes are finis tested. It may in thermal effect and so on. The experiment will follow the Federal Communications Commission (FCC) rules and regulation that approved for RF application. The biological pharmaceuticals samples will base on the Biologics License Application (BLA) and New Drug Application (NDA) rules and regulations.

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1.5 Report Structure

The report structure is the detail of the report ingredients or the layout that divided into few chapters. In this reports, there are six chapter were it is introduction, literature review, methodology, results, discussion and conclusion chapters.

First of first, introduction chapter is chapter one. This introduction chapter will cover briefly describe about the background and overview of this project. Besides that, this chapter covers problems statement, objectives, scope of the project, expected outcome and methodology.

Following that, second chapter contains the literature review or research to get information about this project. In order to get the information which is related, there will have many resources can gained from, such as internet, journals, books and etc. Those facts, figure and information that found from the resources will use as references and informative data. This information will used in this project by comparing info and founds the best method and technique that can implement or add in this project.

In chapter three, mainly focuses on the methodology of the way the project is carried out. In here, the step, methods and process of the experiment and planning schedules of projects will discuss more detail. Follow this methodology will get a better view, proper planed work scope and better understanding on project flow.

In chapter four, all the results are observed and all the measurement is recorded. Beside that this chapter will cover the simulation parts by using the proper software. Based on simulation and experiment results, all the data are well recorded in table form.

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By that, all the comparison study and analyzing is carried out. The well presentable graph, figure and chart will produce in order to summarized the result part overall. Based on the outcome of all table, graph and chart will be briefly discussed. All testing results are attached with the proper aid of figure and table.

Chapter five is the discussion chapter. In this chapter, the results based discussion will carry out. All the fact and figure is declared with giving proper reasons based on theoretical fact. The interrelationship between the theoretical and practical will detailed. The observed, analyzed, and measured fact is well detailed and declared.

The chapter six is the conclusion chapter. This chapter will conclude the whole procedures of the project that including project finding, achievement analysis and conclusion of the research implementation that had been used. If necessary, this chapter can discuss about the suggestion for enhancement in future of the project.

By compile all listed six chapter above will produced a proper full report of Final Year Project. This report structure is based on the fixed rule in UTeM for final year project report. Further related chapter can be added, by approved of supervisor specified but all listed chapter above is necessary included.

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CHAPTER 2

LITERATURE REVIEW

2.1 Introduction

Literature reviews is a progress in read and collect all the informative material such as journal, magazine, article, bulletin and many more, where it used to relate all theoretically, fact and figure which is true and recognize by a specific organization or institute or bodies. Besides that, it all so mean about literature we review regarding project overall. For this project, i was review some IEEE journals, bulletin, books and internet websites.

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2.2 Food & Drug Administration

The Food and Drug Administration (FDA) at United States is responsible for protect and promoting public health by regulation and supervision on food safety, dietary supplements, medications, vaccines, biopharmaceuticals, electromagnetic radiation devices and many more. The Centre for Devices and Radiological Health (CDRH) is one of branch under United States Food and Drug Administration (FDA) where it responsible on premarket approval of medicine device and overseeing manufacturing, performance and safety of devices. The CDRH also responsible for the radiation safety performance of non medical devices which emit certain range electromagnetic radiation.

FDA not allows drugs covered under Biologics License Application (BLA) and New Drug Application (NDA) [8]. Mean while, have a lots of encourage future research involve RF application such as Radio Frequency Identification (RFID) due to insufficient information about potential impact of RF on biologics [23]. The RF application used to track and trace on number or code, and maintain supply chain visibility of products. By history, the RFID system is replacing the bar code technology which has been using past years [6]. The type of bar codes system in RFID is effective which applied the Universal Product Code (UPC) for unique individual items compare to the Electronic Product Code (EPC) for unique to product .

The RFID system gets the information from ID and dates which provide more information in real time and sensor temperature sensitive products entirely. The information is valuable in term of product shipment and the product in market based on current real time e-pedigree which can prevent missed used or food and drugs [2]. The RF radiation can analyze in term of temperature and frequency combination. The thermal effect arise from noticeable change in temperature which comparable to

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twice than Federal Communications Commission (FCC) approved for RF application. A standard was adopted by the FCC for protection against any effects of RF radiation in August 1996 [27, 28]. It because, to maximized the analyze experiment test to investigated the effect on purity and potential stable integrity went RF radiation exposure on biological pharmaceuticals for RF application. Direct and indirect effect on central nervous system has been reported by Soviets at level below 10Mw/cm2._[12,13]. The most recent and most intense public concern stems from both the passage of Radiation Control for Health and Safety Act of 1968 [14,15], and the increasing sales of Microwave ovens [16]. There is considerable data on hemoglobin solution and whole blood, some data skin, and some interest in cellular effects [17, 18]. Ultraviolet irradiation has been subjected of interest for many years due to the hazarders involved [19, 20].

1.2 Problem Statement

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1.3 Objectives

This study embarks on the following objectives: i. To study the RF application and RF radiation.

ii. To develop experiment to characterize on RF Radiation Exposure. iii. To analyze of RF Radiation Exposure on Biological Pharmaceuticals.

1.4 Scope

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1.5 Report Structure

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8 CHAPTER 2

LITERATURE REVIEW

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