pep report

30
Professional Experience Programme (PEP) Report Zubin Shrestha Energy Systems Engineering (Mechanical Stream) College of Engineering & Informatics, NUI Galway Submitted in fulfilment of the requirements for the B.E. (Hons) Degree in Energy Systems Engineering Company Placement: April August 2013 Boston Scientific Ireland, Ballybrit Business Park, Ballybrit, Co. Galway Company supervisor: Mr. Brian Moran Academic Supervisor: Dr. Nathan Quinlan Submission Date: 18 th July 2013

Upload: zubin-shrestha

Post on 22-Jan-2018

364 views

Category:

Documents


3 download

TRANSCRIPT

Page 1: PEP Report

Professional Experience

Programme (PEP) Report

Zubin Shrestha

Energy Systems Engineering

(Mechanical Stream)

College of Engineering & Informatics,

NUI Galway

Submitted in fulfilment of the requirements for the B.E. (Hons) Degree

in Energy Systems Engineering

Company Placement: April – August 2013

Boston Scientific Ireland,

Ballybrit Business Park,

Ballybrit,

Co. Galway

Company supervisor: Mr. Brian Moran

Academic Supervisor: Dr. Nathan Quinlan

Submission Date: 18th July 2013

Page 2: PEP Report

Zubin Shrestha [09424415]

1

ABSTRACT

The author, Zubin Shrestha, completed a five month work placement in Boston Scientific, a global developer, manufacturer and marketer of medical devices whose products are benefited in a range of interventional medical specialties as part of his Third Year Engineering Professional Experience Programme (PEP) course requirement. This report is from a student and not a professional, and is the student’s account of his experience gained from working in Boston Scientific Galway for PEP and is not intended to be used for professional engineering advice.

ACKNOWLEDGEMENTS

I would like to express thanks to all associates engaged in the Facilities Department where I was provided with the chance to be of assistance and work through a variety of tasks embracing numerous aspects of engineering. The variation in the work I was given to do, both practical and theoretical, provided for an invaluable experience that I will hold on to in my career path. The engagement with a wide assortment of fields in the workplace exhibited the importance of adaptation, team work, and communication in a real professional environment very different to college. I would like to show my gratitude to my Supervisor, Brian Moran, who was exceedingly supportive throughout my time at the company, as I feel that I have expanded my foundational knowledge of engineering that I received in college through his guidance.

Page 3: PEP Report

Zubin Shrestha [09424415]

2

TABLE OF CONTENTS

1. THE COMPANY 4

1.1 INTRODUCTION TO BOSTON SCIENTIFIC…………………………………………………………………. 4

1.2 BOSTON SCIENTIFIC GALWAY…………………………………………………………………………… 5

1.3 PRODUCTS………………………………………………………………………………………………...6

1.4 CORE BUSINESSES & DEPARTMENTS…………………………………………………………………… 8

2. PEP 11

2.1 INTRODUCTION TO FACILITIES…………………………………………………………………………...11

2.2 PLANTROOM & COMPONENTS…………………………………………………………………...……...11

2.2.1 AIR HANDLING UNIT (AHU)……………………………………………………………………...12

2.2.2 WATER PURIFICATION SYSTEMS………………………………………………………………...12

2.2.3 CHILLERS………………………………………………………………………………………... 13

2.3 ENERGY SAVING PROJECTS……………………………………………………………………………. 14

2.3.1 DATA CENTER DRY COOLING PROJECT………………………………………………………… 14

2.3.2 GREENMODE MEHODS………………………………………………………………………….. 16

2.3.3 COMBINED HEAT & POWER (CHP) SYSTEM……………………………………………………. 18

2.4 INTRODUCTION TO PEP………………………………………………………………………………… 19

2.5 PROJECTS & TASKS…………………………………………………………………………………… 19

2.5.1 FACILITIES DRAWING UPDATES/REVISIONS USING AUTOCAD SOFTWARE……………………. 19

2.5.2 CLEANROOM CERTIFICATION……………………………………………………………………. 20

2.5.3 FACILITIES PLANT CHECKS……………………………………………………………………… 23

2.5.3.1 MAGNEHELIC GAUGES CHECK………………………………………………………………... 23

2.5.3.2 PEST CONTROL DEVICES CHECK…………………………………………………………….. 24

2.5.3.3 PRESSURE & TEMPERATURE/HUMIDITY SENSORS CHECK………………………………….. 25

2.5.4 SECONDARY TASKS………………………………………………………………………………26

2.5.4.1 ADMIN HALL SEATING ARRANGEMENT INSPECTIONS………………………………………... 26

2.5.4.2 NITROGEN COMPOUND SURVEYING………………………………………………………….. 26

2.5.4.3 BMS DATA REPRESENTATION…………………………………………………………………27

Page 4: PEP Report

Zubin Shrestha [09424415]

3

3. COMPANY SUPPORT 27

3.1 TRAINING………………………………………………………………………………………………... 27 3.2 MEETINGS ATTENDED…………………………………………………………………………………... 28 3.3 TEAM BUILDING………………………………………………………………………………………… 28

4. CONCLUSION & REFERENCES 28

4.1 CONCLUSION……………………………………………………………………………………………. 28 4.2 REFERENCES…………………………………………………………………………………………… 29

Page 5: PEP Report

Zubin Shrestha [09424415]

4

1. THE COMPANY

1.1 INTRODUCTION TO BOSTON SCIENTIFIC

Boston Scientific, Galway is where I was stationed for my five-month engineering work placement. It is one of the many plant branches of the main Boston Scientific Corporation, which operates on an immensely global level. The company is a leader in the development, manufacture, and marketing of highly innovative medical devices. The company has over 25,000 employees worldwide and has significantly evolved the use and performance of less-invasive medical equipment through profound and comprehensive innovation. Boston Scientific is partitioned into several disciplines throughout the world, with each sector striving to improve the quality of patient care on a daily basis. The image below summarizes the determination and attitude the company possesses regarding the development of less-invasive devices.

Fig.1.1 Boston Scientific logo

The core business of the entire Boston Scientific Corporation is partitioned as mentioned above and is as follows:

Interventional Cardiology

Cardiac Rhythm Management

Endoscopy

Peripheral Interventions

Neuromodulation

Electrophysiology

Urology & Women’s Health

Page 6: PEP Report

Zubin Shrestha [09424415]

5

1.2 BOSTON SCIENTIFIC GALWAY

The Boston Scientific plant in Galway is situated in the Ballybrit Industrial Park and is one of the many branch plants of the main corporation that are located worldwide. Within the Boston Scientific Corporation structure, the Galway facility is most unique as it is the only facility that produces products for three of the company’s main product ranges. With a full selection of technologies available on site and employing approximately 3,000 people consisting of full-time employees, part-time employees, and contractors, it is also the only Boston Scientific plant where all processes of product development are carried out on the one site. (E.g. The stents are produced, treated under various conditions, and fully packaged as well.) The products which are used to retrieve, analyze, and treat anatomic sites, bridge over 60 categories and comprise of over 14,5000 product deviations.

Fig.1.2 Galway Plant Branch located in Ballybrit Industrial Park, Galway

Page 7: PEP Report

Zubin Shrestha [09424415]

6

1.3 PRODUCTS

Of the core business areas mentioned previously, the Galway facility focuses mainly on Interventional cardiology, Endoscopy, and Peripheral interventions.The main products that are developed and manufactured in the Galway plant are drug-eluting stents (DES) and balloon catheters. Both of these products are produced to less-invasively treat blocked or damaged arteries in the human body over conventional surgical methods. The company mission statement, “To improve the quality of patient care and the productivity of health care delivery through the development and advocacy of less-invasive medical procedures” emphasises the company’s determination to be of great service to the community. This is achieved through the persistent enhancement of existing medical products and measures and growth of new technologies which can help to reduce risk, trauma, cost, procedure time, and the need for aftercare regarding medical treatment procedures.

Damaged or blocked arteries are triggered by plaque accumulation on the inner walls of the arteries which can be removed using balloon catheters. If the wall is damaged, stents are placed to support the weakened inner walls. The figures below shows blocked arteries and the treatment involved.

Fig.1.3 Blocked arteries Fig.1.4 The artery before and after treatment

Page 8: PEP Report

Zubin Shrestha [09424415]

7

Fig.1.5 A Stent on a Balloon Catheter

The figure above shows a stent on a balloon catheter, which is one of the main product types that are manufactured on site in the Galway facility. The stents are can generally be described as small mesh ‘tubes’ which are inserted into a natural passageway or channel in the body to avert or stabilize a disease-stimulated flow constriction and can also be used to hold a natural channel open inside the body to allow for medical procedure. These types of stents can be utilized to improve the quality of life of a patient suffering from illnesses such as throat cancer, cardiovascular diseases, etc. which underlines the unparalleled high level of distinction and quality to which these medical products are made.

Page 9: PEP Report

Zubin Shrestha [09424415]

8

1.4 CORE BUSINESSES & DEPARTMENTS

Fig.1.6 Boston Scientific’s solutions to Cardiovascular Disease

Fig.1.7 Boston Scientific’s solutions to diseases of the digestive system, airway, and lungs

Page 10: PEP Report

Zubin Shrestha [09424415]

9

Fig.1.8. Boston Scientific’s solutions to treat vascular system blockages

As mentioned beforehand, the Galway facility focuses on three core businesses which are shown in the figures above. It can be seen from these figures that numerous solutions to the medical problems have been developed through the company’s incessant innovation and determination to provide the finest quality service to the patients. This has led to Boston Scientific being one of the leading developers, manufacturers, and marketers of less-intrusive medical solutions.

Coronary artery disease (CAD) occurs when the arteries that provide blood to the heart muscle become hardened and narrowed. Due to the build-up of plaque on the inner walls or lining of the arteries, blood flow is reduced and oxygen supply is eventually decreased. Over time, CAD weakens the heart muscle and contributes to heart failure and Arrhythmias (changes in normal rhythm of the heart beats). Boston Scientific manufactures Balloon Catheters, Stents, and Drug Eluting Stents.

Non-vascular interventions involve the treatment of diseased vessels of the body that are not blood vessels. Examples of non-vascular diseases are Biliary Obstructions (Gallstones), Esophageal Obstructions, Colonic & Duodenal Obstructions, and Tracheobronchial Obstructions. Boston Scientific manufactures various specialized products for each of the conditions. Examples of these products types are Tracheobronchial Stents, Endoscopy balloon and baskets, Wall Stents, etc.

As with the heart, the peripheral vascular system is also a critically important link in the overall circulatory network of the body. Vascular disease occurs when blood vessels that serve as a medium of transport after blood has left the heart via the aorta become damaged or blocked. Blood flow is disturbed as a result and it also affects other systems in the body (e.g. Respiratory, Digestive, and Urinary). Solutions for vascular system damage are balloon angioplasties, carotid stents, stent grafts, and vena cava filter systems.

Page 11: PEP Report

Zubin Shrestha [09424415]

10

Boston Scientific Galway is divided into numerous departments, each playing a vital role in the growth and development of the company. Each of these departments is then again divided according to the role they serve in the development of products and services. The performance of each of the departments is assessed on the capacity of the respective departments to keep within their budgets and maximize savings within their sector. This challenging work environment heartens team work, desire to succeed, and establishes a good working environment, which in turn increases productivity.

The departments involved in production line in the plant are listed below:

DES (Drug- Eluting Stents) - [Zone 2 Controlled Environment]

MCT (Metals Core Technology) – [Zone 4 Controlled Environment]

PCT (Polymer Core Technology) – [Zone 3 Controlled Environment]

POBA (Plain Old Balloon Angioplasty) - [Zone 2 Controlled Environment]

PTA (Percutaneous Transluminal Angioplasty) – [Zone 2 Controlled Environment]

SES (Self Expanding Stents) - [Zone 2 Controlled Environment]

SDC (Stent Delivery Catheter) - [Zone 2 Controlled Environment]

Where, the zone indicates the level of control with Zone 2 Environments having the tightest specifications and Zone 4 having the most relaxed specifications. The ISO standard specification for non-viable 0.5µm airborne particles in Zone

2 (High Risk) and Zone 3 (Medium Risk) controlled environments is 325,000 particles per and 10,560,000 particles

per in Zone 4 (Low/Negligible Risk) controlled environments. The specification for particles at rest for Zone 2 & 3

environments is 3,520,000 particles per and is non-applicable for Zone 4 environments.

Examples of other departments within the plant include:

Site Services

Finance

Human Resources

Quality Operations

Research & Development

Information Technology

Manufacturing Engineering

I was working as a Co-op Engineer in Facilities, a sector of the Site Services department although interaction with a wide variety of departments provided a great deal of experience and highlighted the importance of collaboration and communication in the professional environment. All employees working in their respective site sectors are expected to behave with an equal degree of merit and honesty in order to maximize productivity and continuously enhance product or service quality, which is the primary objective or goal of the company.

Page 12: PEP Report

Zubin Shrestha [09424415]

11

2. PEP

2.1 INTRODUCTION TO FACILITIES

The Site Services Department consists of three primary sub-departments, which are listed below:

Facilities Engineering

Equipment Engineering

Environment, Health & Safety

Facilities are responsible for the improving and upholding of the buildings & site and organizing the provision of site services including security, cleaning etc. throughout the plant. An example of a task carried out by the Facilities Team is ensuring the maintenance of tolerances of various areas with respect to pressure, temperature, and humidity. This sector is also in charge of supplies to several zones of the plant like purified water, nitrogen, argon, etc. Energy saving projects are also of great importance within the Facilities Department and each member of the team has different energy-related projects along with the conservation of site services. During my work placement in the Facilities Department, I was fortunate enough to obtain both practical experiences through tours of plant areas whilst work shadowing engineers of a variety of fields in the sector, and theoretical experience through data representation and calculations involved in tasks that were given to me by different engineers within the department. Data representation played an integral part in the projects and tasks I was involved in, as it made calculations much easier to visualize for analysis and review. As an engineer in Facilities, one has to have a comprehensive knowledge of engineering concepts as jobs related to different fields of engineering are encountered on a daily basis.

Within facilities, weekly meetings are held in which the team members meet with the head manager, who provides a general plant performance update. These meetings usually last for two hours and any problems that had occurred during the previous week are discussed and an appropriate solution is devised and noted. I was given training for correct meeting practices through HR Connect, a personal online training system for employees of the company. At the end of each weekly consultation, each member of the team gives a brief description of work completed during the previous week and updates of any on-going projects. I too was expected to speak at these meetings, and provided updates of any work I was involved in to the team.

2.2 PLANT ROOM & COMPONENTS

The plant is sectioned out into three phases and so, there are three plant rooms within the Galway site to provide for cleanrooms in the three phases. The various clean rooms have to be operated within specific regulations and require being under specialized conditions that are allowed by various components in these plant rooms. Examples of the components in operation in the plant rooms are AHU (Air Handling Unit) Compressors, Humidifiers, Extraction Fans, Vents, Water Purification Systems, and Electrical Control Boards. The piping network for the entire plant can be accessed from these plant rooms and all of the components found in the plant room are monitored electronically in order to detect defects in the machines through the BMS (Building Management System), which is accessed from a normal desktop PC in an admin hall in the plant.

Three of the main systems that I came across and was involved with in my time with the company are listed below:

Air Handling Units (AHU’s)

Water Purification Systems

Chillers

Page 13: PEP Report

Zubin Shrestha [09424415]

12

2.2.1 AIR HANDLING UNITS (AHU):

The AHU’s present on site are used to regulate temperature and humidity of the cleanrooms and also keep the respective rooms at a greater pressure than the areas outside the cleanrooms to ensure the prevention of contamination from particles in the air blowing into the rooms. They are monitored and controlled by the building management system (BMS). The image below shows one of the air handling units on site:

Fig.2.1 An AHU on site

2.2.2 WATER PURIFICATION SYSTEMS:

Water supplied to various cleanrooms of the plant require treated and extremely pure water and the water that is produced from the purification processes on site does so by obtaining water from the mains tank and removing all chlorides away from it. A variety of filters are used and through reverse-osmosis, it is filtered several times to meet the cleanroom requirements. The water is then chilled and transported throughout the plant. There is a continuous flow of water in the piping network around the plant to minimize the risk of microbial growth due to stagnation of the water.

Page 14: PEP Report

Zubin Shrestha [09424415]

13

The images below show the types of water purification systems in the plant:

Figs.2.2 & 2.3 The water treatment systems in the plant

2.2.3 CHILLERS:

Chiller systems remove heat from liquids by means of vapor-compression or refrigeration. The cooled liquid is then circulated through a heat exchanger to cool air or equipment in contact with the flow medium. The chillers I was shown in the plant were those responsible for providing a cool environment for the data server towers in the data center to prevent over-heating. The chillers are shown in the image below:

Fig.2.4 The chiller systems on site

Page 15: PEP Report

Zubin Shrestha [09424415]

14

2.3 ENERGY SAVING PROJECTS

Energy saving is at the heart of the operation of Boston Scientific Galway. Higher energy consumption leads to greater operation costs and also affects the environment in many ways. For manufacturing companies, reduction of costs through energy reduction has emerged as a fundamental approach. The main energy saving projects that I was informed about during my time at the company was the following:

The Installation of a Dry Cooler System for the Data Center

Green Mode Methods

The CHP System

2.3.1 DATA CENTER DRY COOLER PROJECT:

The data center on the site consists of several arrays of data servers that enable the computer network communications not only internally within the Galway plant, but allow information to be monitored by other branches of the main company at different locations worldwide. These towers discharge a lot of heat when in operation and as they are constantly powered on, a cooling system is required to maintain temperatures to prevent over-heating. A network of pipes runs from chiller systems to under the data towers to provide a cool environment for the towers. These chiller systems cool the water directly which flows through this network, thus cooling the towers. The operation of the chillers, however consumes a massive amount of energy and an alternative solution was required.

The Dry Cooler Project proposed this alternative solution to using solely chiller systems to cool the heated environment inside the data center. The main concept of this project was the indirect cooling of water to reduce the chiller usage for the process. Water would still be travelling to the chillers, but they would not require full functioning as the water would have already been chilled to the required temperature to cool down the data server tower units.

The main reason for the large energy consumption for the operation of the chillers is the use of compressors in the system. This requires a significant amount of energy to run and so, using the dry cooling unit, would result in substantial savings reducing the operation of chillers, as well as the major cut of the cost of the entire process of providing a chilled temperature to the data server room. The dry cooler and chillers are connected in series and when

the outside temperature is over 17°C, only the chillers are in operation to chill the water. For outside temperatures less

than 10°C, only the dry cooler is operated. Between 10°C and 17°C, the two systems operate proportionally as

required. With the two systems in series, the data server room is kept within a temperature range of 18-25°C.

Page 16: PEP Report

Zubin Shrestha [09424415]

15

The sketch below demonstrates the proposed dry cooler system which would be placed on the plant roof above the data center building.

Fig.2.5 The Dry Cooler System Project Alternative Idea

Fig.2.6 The Dry Cooler System on site

Page 17: PEP Report

Zubin Shrestha [09424415]

16

2.3.2 GREENMODE METHODS:

This energy saving scheme is developed by a third party company wishing to help big manufacturing companies reduce their energy consumption costs and is a risk based approach to enhancing energy performance in compliant environments.

I attended a presentation meeting with a few members from the Facilities team and the GreenMethods Company who explained the risk based energy saving approaches. GreenMode Methods deliver up to a 40% reduction in production line energy costs through the enhancing of visibility of the company into energy consumption, fingerprinting production consumption, and supporting a greener knowledge of operations within the company.

The methods allow for characterization of consumption within a factory and build an understanding of production portion. It allows for the categorization of opportunities within the company into High/Medium/Low risk options on selected equipment. By providing the equipment owner the data regarding energy consumption, an informed decision can be made. The GMM (GreenMode Methods) 6-Phase methodology is shown in the figure below:

Fig.2.7 The GMM 6-Phase Methodology

Page 18: PEP Report

Zubin Shrestha [09424415]

17

The images below show what each phase of the entire method consists of:

Fig.2.8 The Phases of the GMM Methodology

Page 19: PEP Report

Zubin Shrestha [09424415]

18

2.3.3 COMBINED HEAT & POWER (CHP) SYSTEM:

Combined heat and power is the use of a power station or heat engine to simultaneously generate electricity and heat. The onsite CHP system is powered by natural gas and yields approximately one quarter of the power expended on site (i.e. 1 megawatt). The main motive for the installation of this system involves the extraction of latent heat from the engine, utilizing the exhaust for the heating of the plant phase. As a result, the dependency on boilers is lessened to a certain extent, which saves the company power, gas, and thus, overall operational costs.

The figure below shows the CHP system on site:

Fig.2.9 The energy saving CHP system on-site

Page 20: PEP Report

Zubin Shrestha [09424415]

19

2.4 INTRODUCTION TO PEP

My work experience in the Facilities Department at first consisted of work shadowing several different engineers as I was given tours around the plant and was provided with information about the various ongoing projects that were looked after by Facilities Engineers. I feel I was very lucky to be involved in a variety of engineering fields within the department as it exposed me to an environment where one needed to apply logic to a range of problems faced whether it is mechanical, electrical, or energy related. By experiencing both practical and technical aspects of work involved in Facilities, it was understood that even with a wide variation of fields involved on the same projects or tasks, all members had to stick to the one same goal to achieve their targets whether it was to stick within the budget set out for them or whether the task had to be completed within a target date. I noticed the importance of teamwork as soon as I started my placement as communication seemed to be at the heart of any task undertaken by the department members. Interaction between various people, not only from the same department on a daily basis meant that interpersonal skills were very important in the working environment.

I have been able to assist members of the Facilities department with various tasks and projects during my time in the company as a Co-op Student Engineer. These tasks carried out comprised of both practical and technical work in different areas of the plant. Before I was given any tasks to execute, I was given several tours in various locations relating to the services the Facilities department provide and explanations of how the plant operates with regards to site services.

2.5 PROJECTS & TASKS

Examples of the tasks carried out during my work experience are listed below:

2.5.1 FACILITIES DRAWING UPDATES/REVISIONS USING AUTOCAD SOFTWARE:

External Underground Services drawing update with removal of inactive services and inclusion of new

components in drawing.

Fire Point and Hose Reel Locations drawing update with the removal and addition of fire points and fire safety

related services. (E.g. extinguisher points, fire exits etc.)

Environment, Health & Safety Ladder Locations drawing update with the removal and addition of ladder location

points

Pest Control Layout drawing update with pest control device updates.

Lotus-Valve Chemstar Ovens Electrical Schematic drawing for new ovens required for a new production line to

be introduced to the plant.

Gowning Facilities Surveying to check for the positions of gowning facilities such as wash basins, gown hooks,

troughs, hand dryers, sinks, etc.

Experience gained:

After carrying out drawing updates for the CAD Technician in the Facilities department, I understood the process of

making drawing revisions and the steps that needed to be taken to correctly make drawing updates and upload them

to the department’s network folder system. I also discovered many additional useful tools on the software that was not

covered in college as I received training in the company too.

Page 21: PEP Report

Zubin Shrestha [09424415]

20

2.5.2 CLEANROOM CERTIFICATION:

Cleanrooms in the plant have to be of a certain standard and have to pass a certification test that is carried out on an annual basis. Each of the cleanrooms may have distinct specifications to meet depending on the type of work that is to be carried out in them. Certification of a cleanroom is verified by a third party company who provides a certificate of conformity and approves the certification for the concerned cleanrooms. The cleanrooms are certified and conformed to ISO Class Specification as per ISO 14644, first created from the US Federal Standard Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones. The actual certification report that is provided by the third party company is filled in and examined to see if everything that is recorded in it, is within the specified restrictions. This certification report includes a number of tests that are to be done in the respective cleanroom environment.

The report includes the following tests:

Air Volume Reading

Air Change Calculation

Room Pressurization Test

HEPA Filter Integrity Test

Particle Count Test

Recording Of Temperature & Humidity Profiles

Room Recovery Test

Enclosure Containment Test

Equipment Calibration Check

I carried out the calculations for a number of different cleanrooms and verified the equipment that was used for each of the tests as it was critical to check if the equipment had passed calibration tests and if the equipment information (e.g. Serial Number, Calibration Cert. Number, Date of Expiry, Calibration Date, etc.) matched up to the equipment calibration test sheets that were sent by companies specializing in the calibrating of cleanroom testing equipment. The temperature and humidity readings were taken for the associated areas using a Hygrometer. It was understood that all

results for the production area were to be within the required temperature specification of 19°C to 23°C and 45 ± 5%

Relative Humidity according to the Operation of Building Management System regulation. After having completed the calculations and checks for the report, I created template files for the Air Changes & Particle Count tests for the different clean rooms to make it easier for anyone to carry out the calculations for the report in the future. The image below shows an example of these templates:

Page 22: PEP Report

Zubin Shrestha [09424415]

21

Fig.2.10. An Air Change calculation template for Cleanroom 2

Regarding the Air Change calculations for a cleanroom, volumes of the various areas associated with the cleanroom are measured. A number of volume readings regarding air change are taken at each of the supply air grilles in the concerned cleanroom. The grille air volumes are proportionally balanced, between the different grilles such that roughly equal amounts of air reach all parts of the tested room. These volume readings are then summed for each area. The Air Changes per hour are then calculated by using the following formula shown below. The results obtained from this calculation were then compared to the test result sent in by the third party company to see if they corresponded.

∑ ( ) ( )

( )

Page 23: PEP Report

Zubin Shrestha [09424415]

22

The particle count involved recording two sets of counts for each sample location. Each count set contained number of particles of two different sizes. The two types of particles recorded for each sample location were 0.5μm and 5.0 μm. The two types of particles were counted twice each at the different sample location points in each respective room. A figure of the created template below shows this:

Fig.2.11 A Particle Count Template for a Mixing Lab

Fig.2.12 The Calculation Template for the Particle Count

The figure above shows the calculation steps for the particle count. An average number of particles are calculated for each concerned area. The maximum number of particles is noted along with the location in which there were a maximum number of particles present.

Page 24: PEP Report

Zubin Shrestha [09424415]

23

Experience gained:

The Certification process demonstrated the authorized process of compiling an important document and the

importance of being very thorough when checking various components that may be involved in the full certification

which included the equipment used, the data being recorded, etc. If any mistakes were made when writing the report,

the changes would have to be made in red and it was required for a number of different but relevant authorities to

approve these changes. This was done electronically through the online PDM system that is integrated into the Boston

Scientific Galway network as an online archive of all documents that are uploaded by employees in the company

internally. During my placement with the company, checks of recertification reports were carried out by both DEKRA

and FDA auditors.

2.5.3 FACILITIES PLANT CHECKS:

2.5.3.1 MAGNEHELIC GAUGES CHECK:

A magnehelic gauge is an instrument that is used for the precise measurement of positive or negative differential air pressures. I reviewed magnehelic gauges in all areas of the plant including the corridors, cleanrooms, etc. and checked if they were in need of calibrating or not. Every magnehelic had their own respective ID number associated with them and by using these, their corresponding calibration ranges were checked to see if they were within the specified range. All of this data was then represented in MS Excel. This checking of the pressure gauges also led to drawing updates on AutoCAD as the magnehelics that were not currently in use had to be removed from any existing drawings involving magnehelics. The figure below shows one of the numerous magnehelic gauges installed on site:

Fig.2.13 A magnehelic pressure gauge

Page 25: PEP Report

Zubin Shrestha [09424415]

24

2.5.3.2 PEST CONTROL DEVICES CHECK:

As there was an Environmental, Health & Safety audit on site in June, I was given the task to check on the pest control devices placed across the entire plant. These devices included external rodent bait stations (ERB’s), internal rodent bait stations (ERB’s), electronic fly killers (EFK’s), and crawling insect monitors (CIM’s). The locations of the devices throughout the plant had to be cross-referenced to the pest control layout drawing, which needed an update, as many changes had to be made regarding the locations of these devices. Auditors would check if the pest control system meets specific requirements. Through the process of checking these devices, it was found that there were certain bait station devices out of their positions, and a few electronic fly killers needed their bulbs replaced and/or were out of position. Images of the different pest control devices used on the plant are shown below:

Fig.2.14 An ERB device Fig.2.15 An EFK device

Fig.2.16 A CIM device Fig.2.17 An IRB device

Page 26: PEP Report

Zubin Shrestha [09424415]

25

2.5.3.3 PRESSURE & TEMPERATURE/HUMIDITY SENSORS CHECK:

With the new Lotus Valve production line being introduced to the Galway Plant, a new cleanroom was designated for its manufacture. A report needed to be completed for the quality inspection (QI) of the cleanroom that needed to be verified by a third party cleanroom certification company. All facilities that were related to the new cleanroom had to be checked and their specifications had to be recorded and matched with the report sheet. These facilities components included magnehelic pressure gauges, temperature/humidity sensors, air handling unit (AHU) channel flows, and gowning area amenities. An example of a temperature/humidity sensor is shown below:

Fig.2.18 A temperature-humidity sensor

The temperature-humidity sensors are placed at point locations in the cleanrooms and record temperature and humidity readings at various point locations within the room. The different rooms have temperature and humidity specification range requirement that may be unique according to the nature of work involved to the respective room. The sensor ranges and magnehelic statuses were checked for the new cleanroom sensors and cross referenced to a QI document produced by a Facilities Engineer in the company. The AHU duct lines were followed into the void above the new cleanroom and were also checked for correct ID numbers and statuses.

Experience gained:

First of all, carrying out all of the inspection tasks allowed me to see all areas of the Galway plant. This was a great

opportunity as it provided me a great deal of knowledge regarding a wide range of disciplines in the workplace, not

being restricted to just one field of work. I feel that the data representation and computer work that was accompanied

with these inspection tasks were very helpful in developing my IT, time management, and communication skills in a

professional environment.

Page 27: PEP Report

Zubin Shrestha [09424415]

26

2.5.4 SECONDARY TASKS:

Along with the primary tasks and projects I was involved in as mentioned previously, there were several smaller tasks that were carried out during my placement. These jobs mainly consisted of data representation and plant inspections. Examples of such tasks are outlined below with a summary of each:

2.5.4.1 ADMIN HALL SEATING ARRANGEMENT INSPECTIONS:

As certain employees are relocated or take leave from the company, new recruits and interns are brought in to the company regularly; and it is essential to provide seating in the admin halls for the new personnel. Admin hall seating checks are carried out to allocate the vacant desks in the offices, whether it is a temporary or permanent change. I had to go to several admin halls and carry out these seating checks and report back to the CAD technician to make updates on the admin hall seating plan drawings, which is then uploaded on the company network. This was very important to detect any unoccupied spaces which could be used by personnel in need of working areas.

2.5.4.2 NITROGEN COMPOUND SURVEYING:

There was an ongoing expansion construction of the Nitrogen Compound at the rear of the plant. This change had to be integrated into the architectural site drawing. I had to survey and measure the extension of the compound and report back to update the site drawing on AutoCAD. Whilst in the compound, safety precautions had to be taken with a hard hat, high-visibility vest, and safety boots being compulsory. The company’s health and safety policy are set by senior management, measured and tracked on a regular basis, and are revised to reflect ongoing conditions on-site. I was required to complete an online health and safety training course through the Human Resources Training Program which informed me of all the health and safety precautions to be taken into consideration in various areas of the plant. It was made clear that health and safety management was an integral part of the job and awareness in the working environment helps to build a culture across the company where all employees encompass the company’s policy making it every employee’s responsibility. The image below shows the Nitrogen Compound where I was required to survey:

Fig.2.19 The Nitrogen Compound on site

Page 28: PEP Report

Zubin Shrestha [09424415]

27

2.5.4.3 BMS DATA REPRESENTATION:

The Building Management System (BMS) IS used to monitor and control machine systems across the plant to maintain constant environmental conditions throughout. All machines are watched over with the use of sensors and if any of the systems experience a change from the arranged specifications, the change will be shown on the BMS and the users are alerted. There had been a loss of data for a specific range of time in various areas and I was given the task to use the BMS system to graphically represent this loss of data, transposing the readings recorded by the BMS into MS Excel.

3. COMPANY SUPPORT

3.1 TRAINING

During my time at the company, I was recommended by my supervisor to complete a number of training courses which consisted of both online and in-class exercises. The online training courses consisted of reading and following the documents attached to the training programme and the in-class sessions had to be pre-booked online, and were all carried out in the site’s very own Learning & Development training area. While the majority of the online training programmes were company requirements and suggested by my supervisor, I did take initiative to enroll myself into the in-class training sessions after having consulted with my supervisor. All of these training programmes were organized through the company’s Human Resource Learning Connect website.

The following list provides examples of online training I received:

Control of Facilities Drawings

Good Documentation Practices

Spreadsheet Validation Management

Environment, Health and Safety Awareness

Document and Data Control

Creating a Change Request & a Document on PDM

Process Water Specification

Building Management System Deviation

Environmental Condition Control

Microbiological Air Analysis

Sanitization Of Process Water Systems

Room Pressure Monitoring The in-class training sessions included the following:

Level 2 PowerPoint 2010 Workshop

Excel 2010 Intermediate Course

Problem Solving for Practitioners

Project Management for Operations

The training I received provided me with a deeper understanding of how the company functions on a day-to-day basis and also informed me of the methodology and proper procedures required concerning various jobs that had to be completed. This was an integral part of the placement program as I learnt to adapt to the company system, which was a completely different environment to that which I was used to in college.

Page 29: PEP Report

Zubin Shrestha [09424415]

28

3.2 MEETINGS ATTENDED

In the Site Services department, weekly meetings involving the team members and the manager were held in which the manager updated the team about the performance of the department regarding the different sectors of the plant. Any setbacks or problems are communicated as well and remedial action is agreed on and noted by members involved. At the end of each of these weekly meetings, each team member was required to provide a concise description of tasks and project work carried out during the previous week.

I also attended meetings to discuss on-site projects whilst work-shadowing several engineers in the department. These meetings required proper meeting etiquette and protocol which was notified to me via several training courses received.

3.3 TEAM BUILDING

The importance of teamwork in the company was evident from the first day I started my placement and there were various team building activities organized by the company to develop a stronger employee relationship within the department. Communication and co-operation proved to be essential components to team achievements and the company trips and events provided me with a chance to get to know the members of the department better as I would be working with them on a daily basis.

4. CONCLUSION & REFERENCES

4.1 CONCLUSION

In conclusion, I believe my experience at Boston Scientific has greatly developed my understanding of Engineering in a professional environment as I was fortunate enough to be directly involved in such a large multinational company. The variety of work involved and the satisfaction knowing that your input has a part to play in the improving of lives of many people provided me with an experience that I will definitely take along with me as I further my career path.

At first, I was intimidated with the fact of working for such a large multi-national corporation as the contrast between the college environment that I was used to and the company was too great, but provided with excellent guidance and training from the team I was working with, I felt very comfortable working there. I have found from my time working at Boston Scientific that there is a great level of responsibility in the hands of each and every individual in the company, which was shown in the level of detail and determination that was put into their work throughout the plant. I developed numerous skills through my involvement in the company as I was required to carry out a range of tasks involving a mixture of disciplines. I believe I have enhanced my interpersonal skills as a result of the great amount of interaction that is needed to complete the tasks assigned to me, my IT skills through the completion of the many computer-related duties, and also my time management skills as I was required to complete several tasks and project work for more than a few people at once. I thoroughly enjoyed my time at the company and being part of a company that is such a major service to society on a worldwide basis is an experience that I shall truly value.

Page 30: PEP Report

Zubin Shrestha [09424415]

29

4.2 REFERENCES

http://www.bostonscientific.com

i2e2 GreenMode Methods Handbook

http://www.globalsources.com [reference for Fig.2.17 A Temperature-Humidity Sensor]

http://www.bostonscientific.com/interventional-cardiology/promus-element-

plus/PROMUS_Element_Plus_deliverability.html?

[reference for Fig.1.5 A Stent on a Balloon Catheter]