Nagen Li Final Report

7/27/2019 Nagen Li Final Report

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UNIVERSITI TUN HUSSEIN ONN MALAYSIA(UTHM)

Company Name : Regent Hospital Products Sdn Bhd

Company Address (Main plant) : Lot 9, Lorong Perusahaan 4,

P. O. Box 52, Kulim Industrial Estate,

09000 Kulim,

Kedah Darul Aman.

NAME : NAGENTRAU S/O MUNIANDY

MATRIX NO : AD080153

PROGRAM : DIPLOMA IN MECHANICAL ENGINEERING

1

INDUSTRIAL TRAINING REPORT


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HOST COMPANYS VERIFICATION STATEMENT

We hereby declare that, Nagentrau s/o Muniandy (matrix number: AD080153), student of

Diploma in Mechanical Engineering, University Tun Hussein Onn Malaysia (UTHM) has

successfully undergo his Engineering Industrial Training from 23rd May 2011 to 29th July

2011 (10 Weeks) at Regent Hospital Products Sdn. Bhd.

Due to private and confidential of the company, practical students are not allowed to include the

following items in their reports:

a) Any Process Flow Diagram (PFD) or Piping and Instrumentation Diagram (PID)

b) The chemicals name used by any department

c) Detail of each process

d) Standard Operating Procedures

e) Photos of equipments and instruments

f) The detail design of equipments and instruments

This report is prepared by the above-mentioned student as a partial fulfillment of this Industrial

Training. All the information given in this report is true and does not contain any private and

confidential information or classified data that might in a way or another abuse the companys

policies.

Approved by,

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ABSTRACT

This is an industrial training report that contains a brief introduction of the host company, Regent

Hospital Products Sdn Bhd. This report mainly describes the tasks and main activities that I

carried out during the training duration in the host company. The duration of the industrial

training is approximately 10 weeks and was scheduled from 23rd May 2011 to 29th July 2011.

During the training duration, I had been assigned to Engineering Department, Quality Assurance

Department and Primary Manufacturing Department. I was given the chance to carry out the

company daily tasks, with the guidance of my supervisors. These tasks are crucial for

maintaining the products quality and productivity.

This report ends with some suggestions and recommendations to Universiti Tun Hussein Onn

Malaysia (UTHM), in order to improve the industrial training programme.

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AKNOWLEDGEMENTS

Special thanks to my supervisors, Mr A. Nagarajan (Works Engineer) Mr Zulkipli Ahmad

(Assistant Engineer), Mr Segaran (SHE Manager) and Miss Arni Aslinda (Compounding Senior

Controller), who gave me the opportunity to complete my industrial training pragramme in

Regent Hospital Products Sdn Bhd. The supervision, advices and suggestions assisted me in the

development of daily tasks.

My grateful thanks also go to all of the staffs, as the help and admonishes given contribute to the

successfully progression of the daily tasks.

Thanks for being patient in helping and answering all my problems as well as questions that

might be hard to search in books. Without their help, my industrial training programme might

not be completed successfully. All of the help is much indeed appreciated.

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TABLE OF CONTENTS

CONTENTS PAGE

HOST OF COMPANY STATEMENT 2

ABSTRACT 3

ACKNOWLEDGEMENT 4

CHAPTER 1: INTRODUCTION 6

CHAPTER 2: ENGINEERING DEPARTMENT 15

CHAPTER3: QUALITY ASSURANCE DEPARTMENT 40

CHAPTER4: PRIMARY PRODUCTION DEPARTMENT 43

DISCUSSION AND RECOMMENDATION 60

CONCLUSION 63REFERENCE 64

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1.0 CHAPTER 1 INTRODUCTION

1.1 Company Profile

Regent Hospital Products Sdn. Bhd. is a leading manufacturer of medical gloves, specializing in

powder free surgical, dental and diagnostic gloves. It is a subsidiary of Mlnlycke Health Care, a

global leader in the manufacturing and marketing of surgical and wound care products, with

headquarters based in Gothenburg, Sweden. Products that manufactured in Malaysia, are only for

export purpose. The manufactured gloves are under the brand name Biogel.

Regent Hospital Products manufacturing sites are located at the Kulim Industrial Estates and

Kuala Ketil, in Kedah and the Batang Kali Industrial Estate in Selangor, with a total workforce

of close to 1900 employees.

Regent Hospital Products operates in accordance with international regulatory requirements

including ISO 9001:2008 (Quality Management System), ISO 13485:2003 (European Quality

System for Medical Devices), ISO 14001:2004 (Environmental Management System) and

OHSAS 18001:2007 (occupational health and safety management system).

Manufacturing processes follow guidelines of Good Manufacturing Practices (GMP Standards),

whereby the entire manufacturing process from raw material to finished goods follows a

combination of strict process tests and quality control procedures to ensure that the manufactured

product is of a consistent high quality.

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1.2 Regent Hospital Products Sdn. Bhd. manufacturing sites

Regent Hospital Products Sdn. Bhd. manufacturing sites are located at:

1. Kulim (main plant & expansion plant) manufacturing (main plant started

manufacturing and packaging operation in 1990 until 2000 when the packaging facilities

partially transferred to Kuala Ketil and completed the transfer in year 2001. Capacity

expansion plant started manufacturing operation in 1997. The sites produced sterile and

non-sterile gloves, which eventually sent to Kuala Ketil for packaging.

2. Batang Kali manufacturing and packaging (started operation from 1997 2000 under

Ampri Rubberware Industries Sdn. Bhd. until it was sold to Regent Hospital Products

Sdn. Bhd. in 2000. The site manufactures both sterile & non-sterile gloves. Non-sterile

gloves are packed here and sterile surgical gloves are packed Kuala Ketil facilities.

3. Kuala Ketil packaging (started packaging operation in year 2000 in a new facilities

when the operation was transferred from Kulim. Sterile & non-sterile gloves from Kulim

and sterile gloves from Batang Kali are packed here.

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Figure 1: RHP Kulim (Main Plant) Figure 2: RHP Kulim (Capacity Expansion)

Figure 3: RHP-Batang Kali, Selangor Figure 4: RHP-Kuala Ketil, Kedah

1.3 Process Flow in Main Plant

1.3.1 Process Flow for Incoming Raw Material, Main Plant

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Start

QA Not Approve.

Raw materials need to bereturned to suppliers and

exchange with new lot Quality inspected by QAof raw materials. (Quality Assurance)

Department

QA Approved

End

1.3.2 Glove Process Flow Chart

START

9

Incoming raw material (such as

natural latex, synthetic latex,chemicals & packaging materials)

Release to manufacturing use, once

requested.

QA

Inspection

Store in

warehous

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FAIL

PASS

END

10

COMPOUNDING

(Compound chemical & latex)

AG DIPPING LINE

1-12

PROCESS 1

Washer, Kent Dryer

PROCESS 2

Silker Bay, Kent Dryer

CER INSPECTION

Q-Max Machine

CONTROL ENVIRONMENT PACKING

FINAL PACK

Label Printer

WIPQA LOT

RELEASE

CONTAINER LOADING

SHIPPING INVOISWAREHOUS

E SALES

ORDER


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1.4 Organization Chart

1.4.1 Regent Hospital Products (Kulim & Kuala Ketil)

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1.4.2 Regent Hospital Products (Batang Kali)

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1.5 Company Vision & Mission

Our Vision and Mission establish the overriding targets for all our activities. They are not just

words but will be the benchmarks for us in our process of building a strong corporate brand.

Vision

Our passion for progress will make us the most trusted health care brand in the world.

Mission

To be a global company that provides outstanding solutions for safe, efficient surgical

procedures and gentle, effective wound healing.

1.6 Objectives of the Industrial Internship

To expose students to Engineering practice and professional attitude.

To encourage students to apply the theoretical and practical knowledge in

industry.

To adopt students to working environment and teamwork.

To introduce students to potential employers.

To enhance the ability to improve students creativity skills and sharing ideas with

others

To develop skills in work ethics, communication and management.

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1.8 Training Scope

Table 1: Scope of Work and Tasks in each department

Department Scope of Work / Task

Engineering a) Good Manufacturing Practice: Implementation of 5Sb) Understand the Process Flow of Process Water Treatment.

c) Conduct the iron test of process water.

d) Understand the operation of boilers and usage of steam in manufacturing.

e) Understand the operation of Air Compressor and its important to the process

of manufacturing gloves.

f) Learn the guideline to produce process validation protocols.

Quality Assurance a) Inspection of incoming formers in physical lab.

Primary Production

Department:

- Compounding

Section

a) Understand the chemicals preparation and latex compound.

b) Good Manufacturing Practice:

i) Translate the Standard Operating Procedures of chemical preparations and

latex compound, from English version into Bahasa Melayu version.

c) Understand the Process Flow of Waste Water Treatment and function of each

chemical used.

- Automated Glove

(AG) Dipping Plants

a) Understand the Automated Glove Dipping Process and function of each

chemical used.

b) Troubleshooting on AG Faults

CHAPTER 2 ENGINEERING DEPARTMENT

2.1 Good Manufacturing Practice

2.1.1 5S Introduction

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5S is the method of workplace organization and visual controls, which is popularized by

Hiroyuki Hirano (1990). This methodology originates from Japanese housekeeping idea. The 5S

was named due to five Japanese words, which every word is beginning with letter S.

Table 2: The Meaning of Five Japanese words in English and Their Respective Definitions

Japanese Words Translated in English Definitions

Seiri Sort Separate what is needed in the work area from what is not,

eliminate the unnecessary materials.

Seiton Straighten Arrange the necessary items in an orderly fashion, so that they

are easily accessed.

Seiso Shine Clean the workplace to clean the floor and equipment tidy.

Look for ways to keep it clean.

Seiketsu Standardize Clearly identified and stored the items in designated area

Shitsuke Sustain Implement the 5S daily by everybody, without being told.

Figure 5: The 5S Cycle, which is started from Sort

2.1.2 5S Implementation

Arrangement of Tool in Orderly

Systematic of arrangement of the tools is very important to have efficient assembly, modify,

service or maintenance work done.

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Figure 6: Arrangement of tool in orderly

Positioning Arrangement

Positioning of the instruments / equipments in the fix position is very important to have tidiness

of workplace. Labeling is done on both the instrument / equipments and demarcation line, to

avoid misplace of instruments.

Figure 7: Positioning the equipments or instrument within the demarcation line

Cleaning and Systematic Arrangement of Working Table

It is very important to have a clean and tidy working table. This can prevent misplace of

important documents, thus avoid the loss of working time.

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Figure 8: Cleaning and systematic arrangement of working table

Systematic Arrangement of Files

By using the colour codes and dedication location, it gives a better visual management. Besides

that, it takes shorter time to get the files needed.

Figure 9: Systematic Arrangement of Files

Internal 5S audit

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Internal 5S audit, regularly by person in charge is required, in order to maintain the cleaning and

systematic arrangement of work place. Audit checklist is used to ensure proper implementation

and sustain of 5S.

2.1.3 5S Benefits

To have a:

a. Safe and comfortable environment.

b. Increase work efficiency and support quick setup.

c. Ease maintenance activities.

d. Increase equipment life span.

2.2 Process Water Treatment System

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Reagent 2 Dosage

Reagent 1

Dosage

Reagent 3

Dosage

2.2.3 Description of the Process Water Treatment System

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Incoming Water from

Underground

Filter Vessel

Clarifier

Raw Water

Tank

Filter Vessel

(x3)

Water HoldingTank

Filter Vessel

(x2)

Tube Well Over

Flow Tank

Filter Vessel

Soft Filter

Vessel (x6)

Final Filtration

System for Tube

Well Water (x3)

Incoming Council

Water

Council Water

Tank

Filter Vessel(x3)

Final

Filtration

System (x4)

Sterilization

System (x4)

Process Water

Elevated Tank

Used by AG,

Process 1,

Process 2,

Compounding

& Boiler

Process Water

Storage tank


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Filter Vessels and Filtration System

The entire filter vessels are used to trap the solid particles and iron that contained by tube well

water and council water. Multistage of filtrations are required, in order to trap the solid particles

and iron which escaped from the previous filter vessel.

Soft Filter Vessels

They are used to trap the fine particles which escaped from the filter vessels.

Clarifier

The function of the clarifier is to settle out particles. This can be done by properly recognizing

that small turbulence levels can bring particles together to help them settle more easily. A strong

turbulence level is not allowed as it will break particles leading to an increase in turbidity.

Raw Water Tank

It is used to distribute the water from clarifier to filter vessels. Reagent 1 is dosed in this tank,

with the purpose of increasing pH of tube well water, until the specified range.

Tube Well Flow Tank

It is used to distribute the tube well water from previous filter vessels to the next filter vessel.

Council Water Tank

It is used to receive the incoming council water and tube well water from final filtration system.

Reagent 2 is dosed into the pipelines that are linked from council water tank to filter vessels.

This reagent makes the particles which contained in the water, easier to be trapped by filter

vessels.

Reagent 3

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It is added into the pipelines that are linked from final filtration system to sterilization system. It

has the function to increase the chlorination level of process water to a specified level. It is added

after the filter vessel, as it is a corrosive chemical which can destroy the filter vessels.

Sterilization System

It is use to kill the microorganisms that contained in the water.

Process Water Storage Tank

The process water is stored in this tank before it is distributed to process water elevated tanks.

Process Elevated Tanks

Water from these tanks is distributed to AG processing line, Process 1, Process 2 and

Compounding, by gravity flow.

2.2.4 Test for Iron Concentration in Process Water

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Equipments Required

1. Two empty cells

2. Preheat Thermo Reactor

3. Photometer

Chemicals Required

1. Reagent R-1

2. Reagent R-2

3. Reagent R-3

4. Reagent R-4

Personal Protective Equipment

1. Appropriate Respiratory

2. Gloves

3. Goggle

Procedure

1. 10ml of sample water from process water elevated tanks was pipette into an empty cell.

2. One drop of Reagent R-1 was added into the cell.

3. One dose of Reagent R-2 was added into the cell.

4. The cell was closed tightly, and it was shook for a few second, for better mixing.

5. The cell was heated at the specified temperature in the preheat thermo reactor for one

hour, for reaction between reagents added and process water.

6. Then it was cooled to room temperature.

7. Three drops of Reagent R-3 were added to the cell. It was closed tightly, and was shook

for few seconds, for better mixing.

8. 10ml of distilled water was pipette into a blank cell and it was closed with a screw cap.

9. Photometer was turned on, and the blank cell was inserted into the cell compartment,

method was selected to test on the distilled water, according to the specified guide line.

10. Result was written down.

11. Blank cell was taken out from the cell compartment.

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12. Six drops of Reagent R-4 were added into the cooled cell. It was closed tightly, and

shook for few seconds for better mixing.

13. The cooled cell was inserted to the cell compartment of photometer, and method was

selected to test on the cooled cell, according to the specified guideline.

14. Result was written down.

15. The cooled cell was taken out and the blank cell was placed back to the cell compartment.

16. It was taken out after the result shown (Result should be the same as result from

Procedure 10).

17. on the photometer was pressed before the electricity supplied was turned off.

Result

1. Result of distilled water was 0, as there is no iron concentration.

2. Result of process water showed should lie between the specifications.

2.3 Process of Steam Produced, by Boiler

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2.3.1 Purpose of Boiler Operation

Boiler is used to produce steam. Steam produced is used to heat the air which will be supplied to

the oven.

The heated air is supplied to the driers in AG dipping plants, Process 1 as well as Process 2, in

order to dry the gloves.

2.3.2 Process Flow Chart of Boiler Operation

Heated Water

2.3.3 Description of Boiler Operation

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Incoming Council Water

Water Feed Tank

Boiler

Economizer

Steam Produced

Supplied to AG, Process

1, Process 2 & AirCompressor

Burner

High Temperature Gas

produced

Steam which condensedto water

Reagent 10

Reagent 9

Chimney


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Water Feed Tank

The incoming council water is fed into the water feed tank, before distribute to boiler.

Burner

Gas and oil is supplied to the burner, in order to heat up the water to a specified temperature.

Boiler

Council water that fed to the boiler is heated up to a specified temperature, in order to produce

steam. Steam produced is sent to AG dipping plants, Process 1 as well as Process 2, in order to

dry the gloves.

Reagent 9

Reagent 9 is added into the boiler, in order to remove oxygen of water, since oxygen can cause

corrosion to the internal part of boiler.

Reagent 10

Since council water that is not undergo filtration, contains fine particles, therefore reagent 10 is

added into the boiler, to bring fine particles into contact so that they will collide,

stick together, and grow to a size that will readily settle. Bigger size of fineparticle is known as sludge. Regularly blown down is required, by opening

the specified valve, to remove the sludge from the boiler.

Steam which Condensed into Water

Steam which is condensed into water is sent back to water feed tank, and then to economizer, for

reprocessing.

High Temperature Gas Produced

The high temperature gas is released during the operation of boiler. Safety valve will release the

pressure when the specified pressure has been reached. At the same time, high temperature gas is

released.

Economizer

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The high temperature gas that released from boiler is fed into the economizer. This gas is used to

heat up water from water feed tank to a specified temperature. The heated water cannot reach the

set temperature which is able to generate steam. Therefore, it is transferred to the boiler to be

heated up to the set temperature.

With the help of economizer, the fuel (gas & oil) consumed to heat up the water to set

temperature, is reduced. Therefore, the company is cutting down the operational cost when

generating steam.

Chimney

Chimney is used to transfer the gas exit from economizer to the environment. Since the heat of

higher temperature gas is transferred to water, the out flow of the gas to the environment is in

lower temperature. This can reduce the global warming issue.

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2.3.4 Internal Part of Boiler

Figure 10: Diagram of Internal Part of Boiler

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Double

Spring

Safety Valve

Burner

Force

Draught Fan

Rotatory

CupWet Back Blow

Down

Flue Gas supplied to

Economizer

Check

Valve

Main

Steam

Valve

Main

Hole

Steam

supplied to

Plant

Heated

Water

First

Pass

Tube

Second

Pass

Tube


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Function of Each Part

1. Rotatory Cup:

It is used to break the oil into pieces.

2. Wet back :

It is used to block the oil, preventing from carry over to second pass tube, since only the flame

and heat is allowed to enter the second pass tube.

3. Force Draught Fan:

Environmental air will be forced to enter the combustion chamber. The entered air is used to

force the flame and heat to enter the second pass tube.

4. First Pass Tube & Second Pass Tube:

Flame is generated in the first pass tube. The flame and heat will be forced to enter the second

pass tube, to heat up the water to the set temperature, to generate steam.

5. Expansion Joint :

The steam pass through is in high temperature. Therefore expansion joint is used to prevent

the pipe from cracking.

6. Check Valve :

To ensure the steam is moving in one way.

7. Man Hole :

For maintenance purpose, man will enter the boiler, to disassemble and assemble the internal

parts.

8. Blow Down Outlet :

It is used to discharge the sludge to waste water treatment plant, once the blow down valve is

opened manually.

9. Main Steam Valve :

It is controlled automatically to allow steam to go through.

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10. Double Spring Safety Valve :

Second Spring Safety Valve is set at pressure higher than First Spring Safety Valve. When

the pressure reaches the first set point, pressure is released by First Spring Safety Valve.

When the pressure reaches the first set point, and not released by First Spring Safety Valve,

the pressure will be increased. As it is increased until the second set point, it is released by

Second Spring Safety Valve. They are designed for safety purpose.

11. Check Valve :

It is used to ensure steam is supplied in only one way.

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2.3.5 Internal Part of Economizer

Figure 11: Diagram of Internal Part of Economizer

Description

Generally, steel tubes, are used for the heat-absorbing purpose. Flue gas that produced by boiler

is supplied to economizer. When the flue gas is passing through the steel tube, heat is transfer to

the steel tube, to heat the water. After heat transfer process, the flue gas temperature is reduced,

and it will exit through chimney, to environment.

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High Temperature Flue

Gas is passed through

the Steel Tubes

High

Temperature

Flue Gas

produced

from Boiler

Water from WaterFeed Tank is Fed to

Steel Tubes

Heated Water is fed

to Boiler.

Low Temperature Flue

Gas Exit through

Chimney

Steel

Tubes


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2.4 Process of Air Compressor Operation

2.4.1 Purpose of Air Compressor Operation

A series of process is used to produce dry and cleaned air. The air produced is used to control the

pneumatic or solenoid valves in process water treatment plant, waste water treatment plant and

manufacturing plants.

2.4.2 Process Flow Chart of Operation

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Air is sucked from surrounding

Air Compressor

Air Receiver Vessel

Separator

Filter Vessel

Refrigeration Dryer

Filter Vessel (x2)

Air outlet

Ready to be used

Auto Drain Oil tank

DOE

Waste Water

Treatment

plant

Water tank


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2.4.3 Description of the Operation

Air Compressor

It is used to compress the air that is sucked from the surrounding. A Piece of filter cloth is placed

at the inlet of air compressor, to prevent the unwanted particles from entering it. Partial of the air

sucked is used to cool the pipelines inside the air compressor, while the rest will be compressed

by oil.

Air Receiver Vessel

The compressed air is fed into the air receiver vessel.

Auto Drain System

The oil that carried over from air compressor is trapped by the auto drain system. Then the oil is

sent to the oil tank. The oil collected is sent to DOE (Department of Environmental) regular

basis.

Water Separator

Water is trapped and sent to water tank.

Water Tank

Water from it is sent to waste water treatment plant.

Filter Vessels

The entire filter vessels are used to trap the solid particles and dust that contained in air. Two

stages of filtration are required, in order to trap the particles that escaped from first filtration.

Refrigeration Dryer

It is used to produce the humidity free air.

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2.5.2 American Food and Drugs Administration (FDA)

The Food and Drug Administration (FDA or USFDA) is an agency of the United States

Department of Health and Human Services, one of the United States federal executive

departments, responsible for protecting and promoting public health through the regulation and

supervision of food safety, tobacco products, dietary supplements, prescription and over-the-

counterpharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions,

medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and

cosmetics.

If the manufacturers want to distribute their products (any product that is mentioned in paragraph

1) in US, one of the requirements from FDA is to establish process validation protocol for any

software or equipment installed in their manufacturing plants.

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http://en.wikipedia.org/wiki/Government_agencyhttp://en.wikipedia.org/wiki/United_States_Department_of_Health_and_Human_Serviceshttp://en.wikipedia.org/wiki/United_States_Department_of_Health_and_Human_Serviceshttp://en.wikipedia.org/wiki/United_States_federal_executive_departmentshttp://en.wikipedia.org/wiki/United_States_federal_executive_departmentshttp://en.wikipedia.org/wiki/Public_healthhttp://en.wikipedia.org/wiki/Regulationhttp://en.wikipedia.org/wiki/Food_safetyhttp://en.wikipedia.org/wiki/Tobacco_productshttp://en.wikipedia.org/wiki/Dietary_supplementhttp://en.wikipedia.org/wiki/Prescription_drughttp://en.wikipedia.org/wiki/Over-the-counter_drughttp://en.wikipedia.org/wiki/Over-the-counter_drughttp://en.wikipedia.org/wiki/Pharmaceutical_drughttp://en.wikipedia.org/wiki/Vaccinehttp://en.wikipedia.org/wiki/Biopharmaceuticalhttp://en.wikipedia.org/wiki/Blood_transfusionhttp://en.wikipedia.org/wiki/Medical_devicehttp://en.wikipedia.org/wiki/Electromagnetic_radiationhttp://en.wikipedia.org/wiki/Veterinary_medicinehttp://en.wikipedia.org/wiki/Cosmeticshttp://en.wikipedia.org/wiki/Government_agencyhttp://en.wikipedia.org/wiki/United_States_Department_of_Health_and_Human_Serviceshttp://en.wikipedia.org/wiki/United_States_Department_of_Health_and_Human_Serviceshttp://en.wikipedia.org/wiki/United_States_federal_executive_departmentshttp://en.wikipedia.org/wiki/United_States_federal_executive_departmentshttp://en.wikipedia.org/wiki/Public_healthhttp://en.wikipedia.org/wiki/Regulationhttp://en.wikipedia.org/wiki/Food_safetyhttp://en.wikipedia.org/wiki/Tobacco_productshttp://en.wikipedia.org/wiki/Dietary_supplementhttp://en.wikipedia.org/wiki/Prescription_drughttp://en.wikipedia.org/wiki/Over-the-counter_drughttp://en.wikipedia.org/wiki/Over-the-counter_drughttp://en.wikipedia.org/wiki/Pharmaceutical_drughttp://en.wikipedia.org/wiki/Vaccinehttp://en.wikipedia.org/wiki/Biopharmaceuticalhttp://en.wikipedia.org/wiki/Blood_transfusionhttp://en.wikipedia.org/wiki/Medical_devicehttp://en.wikipedia.org/wiki/Electromagnetic_radiationhttp://en.wikipedia.org/wiki/Veterinary_medicinehttp://en.wikipedia.org/wiki/Cosmetics


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2.6 Similarities of Requirements from ISO 13485 & FDA: Process Validation Protocol

2.6.1 Introduction

Process validation is part of the integrated requirements of a quality management system. It is

conducted in the context of a system including design and development control, quality

assurance, process control, and corrective and preventive action.

Process validation protocol is a written and approved plan, stating how process validation will be

conducted, including test parameters, product characteristics, and production equipment as well

as decision points on what constitutes acceptable test results.

Process validation protocol be generally be regarded as comprising of three parts

a) An initial qualification of the equipment used and provision of necessary services also

know as installation qualification (IQ) protocol.

b) A demonstration that the process will produce acceptable results and establishment of

limits (worst case) of the process parameters also known as operational qualification

(OQ) protocol.

c) Establishment of long term process stability also known as performance qualification

(PQ) protocol.

2.6.2 Members of the validation team

Members of the validation team could include representatives from or personnel with expertise

in:

Quality Assurance

Engineering

Manufacturing

Research & Development

Purchasing/Planning

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2.6.3 Considerations of IQ, OQ and PQ Protocols

IQ Protocol

Important IQ protocol considerations are:

Equipment / software design features

Installation conditions (wiring, utilities, functionality, etc.)

Calibration, preventative maintenance, cleaning schedules

Safety features

Supplier documentation, prints, drawings and manuals

Software documentation

Spare parts list

Environmental conditions (such as clean room requirements, temperature, and humidity)

IQ Protocol is established by objective evidence that all key aspects of the process equipment

and ancillary system installation adhere to the manufacturers approved specification and that the

recommendations of the supplier of the equipment / software are suitably considered.

OQ Protocol

Important OQ Protocol considerations include:

Process control limits (time, temperature, pressure, lines peed, setup conditions, etc.)

Software parameters (if there is a software installation)

Process operating procedures

Material handling requirements (if there is a equipment installation)

Process change control limits (time, temperature, pressure, lines peed, setup conditions, etc.)

Short term stability and capability of the process (control charts)

Potential failure modes, action levels and worst-case conditions (Failure Mode and Effects

Analysis, Fault Tree Analysis)

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Statistically designed experiments to optimize the process after equipment / software

installation

OQ Protocol is mainly established by objective evidence that upper and lower process control

limits and action levels which result in product that meets all predetermined requirements. All

the considerations must be evaluated and documented during process validation to determine the

robustness of the process and ability to avoid approaching worst case conditions.

PQ Protocol

PQ considerations include:

Actual product and process parameters and procedures established in OQ

Acceptability of the product

Assurance of process capability as established in OQ

Process repeatability, long term process stability

PQ Protocol is established by objective evidence that the process, under anticipated conditions,

consistently produces a product which meets all predetermined requirements.

Process and product data should be analysed to determine what the normal range of variation is,

for the process output. Knowing the normal variation of the output is crucial in determining

whether a process is operating in a state of control and is capable of consistently producing the

specified output.

Appropriate measures should be taken to eliminate controllable causes of variation. Eliminating

controllable causes of variation will reduce variation in the process output and result in a higher

degree of assurance that the output will consistently meet specifications.

2.6.4 Final report

A final report should be prepared for each IQ, OQ and PQ protocols. This report should

summarize and reference all protocols and results. It should derive conclusions regarding the

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validation status of the process. The final report should be reviewed and approved by the

validation team and appropriate management.

2.6.5 Revalidation

Revalidation means that the IQ, OQ, PQ protocols and final report are needed to be redone.

Revalidation may be necessary under such conditions as:

change(s) in the actual process that may affect quality or its validation status

change(s) in the product design which affects the process

transfer of processes from one facility to another

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CHAPTER 3 QUALITY ASSURANCE DEPARTMENT

3.1 Physical Lab

3.1.1 Purpose of Physical Lab

Every delivery of incoming former needs to be inspected before they are released to production

use. Formers are the molds used to produce medical gloves.

3.1.2 Equipment Required for:

Visual Inspection

1. Magnifying Glass

2. Eye Piece

Dimension measurements

1. Measuring Tape

2. Digital Height Gauge

3. Vernier Caliper

4. 2B Pencil (to mark the line)

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3.1.3 Aspect of each formers inspection:

a) Visual inspection:

1. Check that the actual size of each former is tally with the label on the former carton.

2. Check for colour spot, pit, pimple and iron spot on each former.

If the actual size of a former is deviated from the label on the former carton, it will be rejected,

individually.

Either colour spot, pit, pimple or iron spot appears on a former, the respective former will be

rejected.

b) Dimension measurements

1. Total length

2. Wrist circumference

3. Shank circumference

4. Every finger length

5. Every finger circumference

6. Former weight

7. Palm circumference

8. Socket (inner and outer)

If one of the measurements of a former does not fall between the specifications given, the

respective former will be rejected

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Figure 9: Diagram of Dimensions Measurements

3.1.4 Inspection Procedures:

They are inspected in detail, according to Standard Operating Procedures.

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CHAPTER 4 PRIMARY PRODUCTION DEPARTMENT

4.1 Compounding

4.1.1 Chemicals and Latex Compound

Compounding is a section which compound the chemicals and latex. Chemical A1 and Chemical

A2 are compounded, become Chemical B1, and supplied to Process 1. It is used to wash the

gloves from AG dipping plants, to remove the chemical residues, and also to maintain the inner

smoothness of the gloves. The rest of the chemicals are compounded before they are added to

latex. Both the chemicals and latex are compounded according to the Standard Operating

Procedures.

The equipments used to compound natural rubber latex and synthetic rubber latex cannot be

mixed up. They must have a clearly label, and used separately.

4.1.2 Differences between Natural Rubber Latex and Synthetic Rubber Latex

Natural rubber latex

It is a milky fluid comprising 30 - 40% of the rubber hydrocarbon particles suspended in a serum

together with a few percent of other non-rubber substances such as proteins, lipids, carbohydrates,

sugars and alkaloids, starches, , tannins, resins, and gums. The remaining major component is

water.

Synthetic rubber latex

Synthetic rubber latex is produced protective chemicals. These do not contain proteins.

Latex Allergy

The proteins contained in natural rubber latex are contributing for latex allergy. Proteins kept on

the skin for long periods cause a different immune reaction in the body, if compared to proteins

which we eat.

Many people with spina bifida (is a developmentalbirth defect caused by the incomplete closure

of the embryonic neural tube) are allergic to natural latex rubber, as well as people who have had

multiple surgeries, and people with Anaphylaxis (is an allergic reaction that can be fatal within

minutes, either through swelling that shuts off airways or through a dramatic drop in blood

pressure). Proteins may cause death to this population.

43
http://en.wikipedia.org/wiki/Alkaloidhttp://en.wikipedia.org/wiki/Starchhttp://en.wikipedia.org/wiki/Tanninhttp://en.wikipedia.org/wiki/Resinhttp://en.wikipedia.org/wiki/Natural_gumhttp://en.wikipedia.org/wiki/Spina_bifidahttp://en.wikipedia.org/wiki/Birth_defecthttp://en.wikipedia.org/wiki/Embryohttp://en.wikipedia.org/wiki/Alkaloidhttp://en.wikipedia.org/wiki/Starchhttp://en.wikipedia.org/wiki/Tanninhttp://en.wikipedia.org/wiki/Resinhttp://en.wikipedia.org/wiki/Natural_gumhttp://en.wikipedia.org/wiki/Spina_bifidahttp://en.wikipedia.org/wiki/Birth_defecthttp://en.wikipedia.org/wiki/Embryo


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4.1.3 Design on Mixing Tanks of Chemicals and Latex

Since every mixing tank is not equipped with baffles, therefore the stirrer shaft is design in such

way to be lifted up, at 10o, to reduce swirling and vortex of fluid. Fluid will be well mixed,

without swirling or vortex.

All the design details are kept as companys private and confidential terms.

Figure 10: Diagram shows the lifted stirrer shaft of mixing tank

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Motor

Stirring Shaft

Tank Diameter

Stirrer

10o

ExtendedMetal


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4.1.4 Good Manufacturing Practice (Translating SOP)

After go through the latex and chemical compounding procedures, I was assigned to create a

standard format, in order to modify the existing English version of SOP in the batch cards used,

into the standard format. Another responsibility is to translate the Standard Operating Procedures

(SOP) in the batch cards used, from English Version into Bahasa Melayu Version.

After modifying batch card, or creating a new batch card, both of them must be updated in QA

Documentation Control Department. The completed batch cards were sent to QA Documentation

Control Department, waiting to be approved, and then issued. The issued date and the new

documentation number were given and registered, once the batch cards were approved to be

used.

Table 3: Template for Standard Format of SOP in English

REGENT HOSPITAL

PRODUCTS SDN.

BHD.

PREPARED BY: CHECKED BY: ISSUE DATE: DOCUMENT

NO:

PRODUCT: SUBJECT TO:

LOT NO.: SAIZ: LITRE EXPELLER NO: MANUFAC.

DATE:

MATERIAL LOT NO. OF

MANUFACTURER:

MATERIAL

LOT NO.:

STANDARD

QUANTITY

(KG)

SPECIFICATION

( KG)

WEIGHED

QUANTITY

(KG)

WEIGHED BY: CHECKED BY:

PROCEDURES: CHECKLIST

(MARK AS )

PERFORMED BY: CHECKED BY:

1.

2.

3.

4.

5.

DOCUMENTATION COMPLETED: CHECKED BY:

Table 4: Template for SOP in Bahasa Melayu

REGENT HOSPITAL

PRODUCTS SDN.

BHD.

DISEDIAKAN OLEH: DISEMAK OLEH: TARIKH

DIKELUARKAN:

NO. DOKUMEN:

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PRODUK: SUBJEK KEPADA:

NO. LOT: SAIZ: LITER NO. EKSPELER TARIKH

DIKELUARKAN

BAHAN NO. LOT

PEGELUAR:

NO LOT

BAHAN:

KUANTITI

PIAWAI (KG)

SPESIFIKASI

( KG)

KUANTITI

DITIMBANG

(KG)

DITIMBANG

OLEH:

DISEMAK

OLEH:

LANGKAH-LANGKAH: SENARAI SEMAK

(TANDAKAN )

DILAKUKAN

OLEH:

DISEMAK

OLEH:

1.

2.

3.

4.

5.

6.

7.

8.

ADAKAH SEMUA DISI DENGAN LENGKAP: DISEMAK OLEH:

4.2 Waste Water Treatment

4.2.1 Purpose of Waste Water Treatment

The waste water collected in the Waste Water Treatment Plant is mainly from the dipping

stations (AG processing line), Process 1, Process 2, Compounding and air compressor. The major

pollution concern are alkalinity of raw waste water, high Biological Oxygen Demand (B.O.D.),

high Chemical Oxygen Demand (C.O.D.) level, indicated pollution level of organic and

inorganic matter, suspended solids and chemicals content. Most of these pollutants are from the

raw material used in the manufacture of Biogel gloves. Waste water treatment plant is required to

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reduce the pollutant level as specified by the local regulatory body, Department of

Environmental, also known as DOE, and to comply with the clauses in ISO 14001.

4.2.2 Process Flow Chart of Waste Water Treatment

Reagent 4 &Reagent 5

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Primary Treatment Tank

Reception Tank

(Incoming of Raw WasteWater)

Waste Water from Production

Reception Tank

(Incoming of Chemical A Waste

Water)


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Dosage Reagent 8

Dosage

Reagent 6Dosage

Reagent 7

Dosage

Bacteria &

Urea

Dosage

4.2.3 Description of the Waste Water Treatment

Reception Tank

Reception tank is the collection point of waste water generated from Compounding, AG, Process

1, Process 2 and air compressor. There are two reception tanks, due to Chemical A is a high

alkalinity chemical. Therefore it is needed to be treated in chemical treatment process tank,

before it is lifted to another reception tank.

Primary Treatment Tank

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Bulk Packing

Balancing Tank 1

Final Discharge to Common

Drain

Humus Tank

Biological Tower (x2)

Bio Feed Tank

pH Adjustment Tank

Filter Media (x5)

Filter Feed Tank

Settlement Tank (x2)

Flocculation Tank

Balancing Tank 1

Treated Water

Sludge Collection Tank

Chemical treatment Process Tank

Humus Pit

Filter Press

Send to DOE Disposal

Sludge Dryer

Water

Collected


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The addition of chemicals, Reagent 4 is dosed, to break up the molecule of waste water, while

Reagent 5 is dosed, to adjust the pH of waste water until it falls between the specifications.

Balancing Tank

The tanks are fitted with a submersible blower and with a high speed mixer

to remove a typical chemical, by volatilization of the chemical.

Flocculation Tank

With the help of Reagent 6 dosing, flocculation bring particles / flock into

contact so that they will collide, stick together, and grow to a size that will

readily settle. Bigger size of flock is known as sludge.

Settlement Tank 1 & 2

Sludge will be settling down and will be sent to sludge collection tank, while the upward water

will be sent to filter feed tank.

Filter Feed Tank

This tank consolidates water from both settlement tank and distributes to the

filter vessels.

Filter Media 1 -5

The water leaving the sedimentation tank still contains flock particles. Water filtration is a

process for separating suspended or colloidal impurities from water by passage through a porous

medium (sand).

pH Adjustment Tank

The pH of the waste water requires to be neutralized to a specified range, by dosing Reagent 7.

Bio Feed Tank

Microorganism is added to decompose the content of the waste water, while

urea is used as a food of microorganism, so that they can survive for one

week.

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Biological Tower 1 & 2

The biological towers consist of a bed of a highly permeable medium to which microorganism is

attached and through which waste water is percolated or trickled. The filter media consist of

granite rocks.

Humus Tank

Excess growths of microorganism from the rock media would cause

undesirably high levels of suspended solids in the plant effluent if not

removed. Thus, the flow from biological towers is passed through a

sedimentation basin known as humus tank to allow these solids to settle

down. The humus tank is referred to as a final clarifier.

Humus Pit

The humus pit is used to collect the accumulated settled solids in the humus

tank and simultaneously transfer the solids to the sludge collection tank.

Final Discharge

This is the final physical unit of the waste water treatment plant. The unit is fitted with a flowrate meter for the purpose of process control, process monitoring and discharge. The water flow

is measured in m3/ hour. The discharge pit also serves as a sample collection point for water

treatment analysis. Waste water analysis is conducted by Contract Company once in a month,

and result will be sent to DOE, once in a month too.

Chemical Treatment Process Tank

Reagent 8 is added, with the purpose to adjust the pH Chemical A waste water to a specified

range.

Sludge Holding Tank

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Sludge is hold by this tank. 98% of the sludge mass is water.

Filter Press

Filter press is used to separate water from the solid constituents. The water

collected is sent to incoming of raw waste water reception tank, to undergo

series of process.

Sludge Dryer

It is used to dry the sludge. The moist of the sludge will be vaporized,

through the scrubber unit.

Bulk packing

The dry sludge will be packed according to the specified quantity, and will be

collected by DOE, once it reaches the maximum quantity allowed, for proper

disposal. The dry sludge must be stored in containers / jumbo bagwhich aredurable and which are able to prevent spillage or leakage into the

environment, since it is a toxic waste.

4.3 Automated Glove (AG) Dipping Plant

4.3.1 Purpose of AG Dipping Plant and Former Loading

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There are eight AG dipping plants in main plant, which are used to produce gloves. Each type of

gloves is produced in their respective AG dipping plants.

The equipments used for natural rubber latex products and synthetic rubber latex products cannot

be mixed up. They must have a clearly label, and used separately.

Formers are used to dip into the chemicals and latex, to produce gloves. Formers are varying

from size 5.5 - 9.5, for both the left hand side and right hand side.

For each shift, there is a plan for former loading for every AG dipping plant. The purpose of

former loading is to replace the cracked formers with the new formers, and also to load and

unload the formers, according to the sizes of gloves ordered.

4.3.2 Process Flow Chart of Each AG Dipping Plant

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Reagent B Former Cleaning Initial Beading Station


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4.3.3 Description of AG Dipping Plant

Reagent B Former Cleaning Dipper

53

Reagent A Former Cleaning

Reagent C Former Cleaning

Former Brushing Station

Reagent E Dryer

Flood wash Station

Preheat Dipper & conditioningformers with a layer of

Reagent E Dipper

Latex Dipper

Pre Bead Oven

Ink Jet Printer

Leaching Station

Reagent F Dipper

Reagent F Rinse Tank

Pre Reagent G Dryer

Reagent G Dipper

Final Beading Station

Vulcanizes (x8)

Pre Strip Tank

Stripping Station


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This is a former cleaning dip. The area around the dipper is fitted with a fume extraction unit, to

meet Safety, Health and Environmental (SHE) requirements.

Reagent A Former Cleaning Dipper

This is a former cleaning dip. The area around the dipper is fitted with a fume extraction unit, to

meet SHE requirements.

Reagent C Former Cleaning Dipper

This is a former cleaning dip.

Former Brushing Station

The Former Brushing Station is used to brush the formers. Water pre-spray precedes the brushes

in this station.

Flood wash Station

This is used to wash / rinse the formers after cleaning. Process water is supplied.

Preheat Dipper & conditioning formers with a layer of Reagent D

This is used to heat up the formers while conditioning it with a layer of Reagent D. Reagent D is

fed continuously using a dosing pump.

Reagent E Dipper

This is used to deposit a layer of Reagent E on the formers. The dipper is constantly kept in

circulation via a pump, to prevent creaming issue.

Reagent E Dryer

This is used to dry the formers before latex dipper entry. Formers are positioned fingers down

for latex entry.

Latex Dipper

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Latex in the dip tank is continuously circulated using impellers. Temperature of the latex is kept

regulated using chiller water. Two (2) blob knockers are fitted along the exit cam to remove

excess finger tip latex. A 3-row sweep cam ensures that latex on the former fingers is evenly set.

Latex dipper impeller speed is controlled between the specifications. Dwell configurations are

adjustable; these include flat dwell time, bead step height and bead step dwell length. Latex is

fed-in automatically from the reserve tank through a ball valve controlled by level sensors.

Pre Bead Oven

This dry the glove cuffs partially to allow proper beading.

Initial Beading Station

Four (4) beading motor systems are provided. Rollers are used for beading.

Ink Jet Printer

A clear print of size, hand, logo / type and sequence numbering is required on each glove.

Leaching Station

This extracts water soluble material from the gelled gloves. There are 2 leach tanks. Water flow

rate is controlled using a ball valve and actual flow read on a float flow indicator.

Reagent F Dipper

It is used to condition glove surface for polymer adhesion. The area around the tank is fitted

with an extraction unit to meet SHE requirements.

The dip tank is continuously kept circulated using a pump. Temperature control is done using a

thermostatically controlled chilled water unit in the tank.

Reagent F Rinse Tank

Processed water is used to rinse-off Reagent F. Water continuously feeds in and overflows out,

while being circulated by pump.

Pre Reagent G Dryer

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This reduces the amount of water carried over by the formers from the rinse tank into the

polymer dipper.

Reagent G Dipper

This applies a layer of Reagent G onto the preconditioned glove. The dip tank is continuously

kept circulated using a pump. Temperature control is done using a thermostatically controlled

chilled water unit in the tank.

Final Beading Station

Two (2) beading motor systems are provided. Rollers are used for beading.

Vulcanizes (x8)

These dry and cure the gloves. Air temperature is controlled and monitored using a series of

temperature controllers.

Pre Strip Tank

Processed water is used to reduce glove and former temperature before stripping process. Water

continuously feeds in and overflows out.

Stripping Station

Gloves are stripped and placed in their respective prams, and ready to be transferred to Process 1,

when achieving the set weight.

4.3.4 Troubleshooting On Faults of AG Dipping Plant

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Defects on Gloves: Solutions:

1. Thick Bead 1. Adjust the alignment of rollers.

2. Check latex level in Latex Dipper, repair or change the level sensors.

2. Thin Bead 1. Adjust the alignment of rollers.

2. Check latex level in Latex Dipper, repair or change the level sensors.

3. Torn Bead 1. Change the rollers.4. Holes 1. Check vulcanizes temperature and adjust it to the specified range.

2. Check foreign particles on formers. Stop the running of products, and clean the

formers, from reagent B cleaning formers Dipper until Flood wash Station, while prevent

from dip into chemical tanks and latex dipper.

5. Dirty Sport On

gloves

1. Check foreign particles on formers. Stop the running of products, and clean the formers,

from reagent B cleaning formers Dipper until Flood wash Station, while prevent from dip

into chemical tanks and latex dipper.

4.4 Process 1

4.4.1 Washing and Drying Process

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QA approved gloves from AG dipping plants are sent to Process 1, lot by lot (each lot has 80 kg

of gloves), for washing and drying purpose. Both the washing and drying procedures are

conducted according to the Standard Operating Procedures.

Washing

QA approved gloves from AG dipping plants are sent to washer in order to remove the entire

chemical residue, and at the same time, to maintain the inner smoothness of gloves. They are

washed with the Chemical B1.

Washers are divided into two zones; one is for natural rubber latex products, while another one is

for synthetic rubber latex products. Gloves are washed, according to their respective washers.

The gloves are weight according to the specified quantity before they are sent to washer. Each

washer only support for a specified quantity. The duration for washing had been set. All the

activities of washers are controlled by PLC (Programmable Logic Control).

Drying

Dryers are divided into two zones; one is for natural rubber latex products, while another one is

for synthetic rubber latex products. Gloves are dried, according to their respective dryers.

The gloves from washers are weight before they are sent to dryers. Each dryer only support for a

specified quantity. The duration for drying had been set. All the activities of dryers are controlled

by PLC (Programmable Logic Control).

After Drying

The gloves are sent to Process 2 for initial sterilization, after QA approved.

4.4.2 Inspection of Gloves by Using Water Tight Test (WTT) Machine

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WTT machine is used to test the holes on gloves produced. Adapters in WTT machine used

according to the labels, for natural rubber latex products and synthetic rubber latex products.

For each lot of QA approved gloves, only an amount of gloves are picked randomly, to be tested

on holes. The picked gloves are placed on the adapter of the WTT machine. Water will be filled

in each glove automatically. Detail procedures to conduct the test are not allowed to include in

this report.

If none of the gloves are leaking after filled in with water, the respective lot can be sent for

washing and drying process.

However, if one hole is found on a picked glove, the entire gloves from the respective lot need to

be inspected. Those gloves with holes are sent to be shredded.

CHAPTER 5 DISCUSSION AND RECOMMENDATION

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5.1 Discussion

It is necessary to conduct the preventive maintenance, servicing and calibration on machines,

equipments and instruments used, on a well planned interval, according to the written

procedures. Importance of maintenance, servicing and calibration are as bellow:

a) Downtime of the machines during production will be reduced. Therefore the productivity can

be optimum, while the waste of chemicals can be minimized.

b) To prolong the lifespan of machines, equipments and instruments.

c) To avoid malfunction of any machines, equipments and instruments, that may lead to

accidents.

Every modification or new development of any documentation must be updated from time to

time with QA Documentation Department. It is important to have a record, for the ease of

revision in the future.

Safety and health of employees, vendors and contractors are the first consideration in working

area. In order to comply with OHSAS 18001 Regulations, the following item must be complied:

a) Personal Protective Equipments, such as appropriate respiratory, gloves (acid resistant gloves

required if handling the corrosive material), goggles, face shield, ear plug and safety shoes are

required in the designated area.

b) Fire drill training is held planned interval, to train the people in duties and escape procedures

to be followed in case of fire. Emergency Response Team is built and the members are well

trained, to give fully play on their responsibility in case of fire.

c) Safety and Health Committee meeting is held at least once in three months. This meeting is

held to discuss, investigate, inspect and review any issue that related to safety and health in

work place.

d) Well classification, packaging and labeling of the hazardous chemical.

e) To have Material Safety Data Sheet, from vendors, of each chemical used.

Environment Management is required, to maintain the ecosystem. The following items must be

complied, in order to comply with Environmental Management System, ISO 14001:

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a) Any facility or process that discharge air impurities into open air, the parameters of air

impurities must falls between the specifications. The parameters are analyzed on a regular

basis.

b) The storage and clearance of contaminated wastes are done, in accordance to the writing

procedure.

c) Refrigerant systems are serviced by contractor at planned interval.

Work flow must be well planned and followed to have success work done in date. Usually Gantt

chart is used as a guideline to have success work done in date.

Good Manufacturing Practice (GMP) is very important. Employees have to comply with GMP,

to perform their job in accordance to established procedures. This can maximized the

productivity, while reducing the waste of chemicals and materials used. Therefore, operational

costs will be reduced.

Good communication skill among all is one of the important tools to get the work done and find

the solutions of any problems. All these cannot be done by only a person, working as a team is a

key to success.

When there is a problem exists, pushing the faults toward another is not a way to settle it. The

correct action is to work as a team, to investigate the causes, and then look for the solutions, as

soon as possible.

5.2 Recommendation

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I would like to express a recommendation to UTHM, in order to make the industrial training

more successful and meaningful.

Both the technical skills and management skills are useful and may lead us to become a

professional engineer in the future. Therefore UTHM should set the industry training aspects, fix

the students to spent a certain period of time to learn on both the technical skills and management

skills.

CHAPTER 6 CONCLUSION

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This internship was very fruitful to me as I was exposed to the real process

design in industry. By assigning me to the different departments, I was

having a chance to go through the different process in each department.

Every department is playing their important role and contributing in order to

produce the quality products.

Rather than process design, I was assigned to go through the reading assignment, on companys

ISO (International Standardize of Organization) certificates. These show me the clauses to be

complied by company, to achieve the ISO certificates.

I was given the chance to involve in the daily tasks of this company. All the given tasks were

finished right at the time, with the guidance and supervision from supervisors as well as

colleagues. All these cannot be done by my own strength, working as a team is very important.

This training wise me up a lot in communication skill, personality and point of view.

As a conclusion, I feel rather glad to undergo training in Regent Hospital Sdn. Bhd. The

experiences gained sure can lead me to become a professional engineer in the future.

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CHAPTER 7 REFERENCE

[1] Nicholas Hebb (n.d.). Flow Chart Symbols. Retrieved 10 May 2010, from http://

www.breezetree.com/article-excel-flowchart-shapes.htm

[2] Hiroyuki Hirano and Bruce Talbot (1995). 5 Pillars of the Visual Work Place: The Source

Book of 5S Implementation, Productivity Press, United States of America.

[3] Company Library

Nagen Li Final Report

Documents

Transcript of Nagen Li Final Report