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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
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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.
35
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/Cosmetics7/27/2019 Nagen Li Final Report
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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.
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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/Embryo7/27/2019 Nagen Li Final Report
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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
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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