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UNIVERSITI TUN HUSSEIN ONN MALAYSIA(UTHM)

INDUSTRIAL TRAINING REPORT

Company Name Company Address (Main plant)

: :

Regent Hospital Products Sdn Bhd Lot 9, Lorong Perusahaan 4, P. O. Box 52, Kulim Industrial Estate, 09000 Kulim, Kedah Darul Aman.

NAME MATRIX NO PROGRAM

: : :

NAGENTRAU S/O MUNIANDY AD080153 DIPLOMA IN MECHANICAL ENGINEERING

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,

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.

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.

TABLE OF CONTENTS

CONTENTS HOST OF COMPANY STATEMENT ABSTRACT ACKNOWLEDGEMENT CHAPTER 1: INTRODUCTION CHAPTER 2: ENGINEERING DEPARTMENT CHAPTER3: QUALITY ASSURANCE DEPARTMENT CHAPTER4: PRIMARY PRODUCTION DEPARTMENT DISCUSSION AND RECOMMENDATION CONCLUSION REFERENCE

PAGE 2 3 4 6 15 40 43 60 63 64

1.0 1.1

CHAPTER 1 INTRODUCTION 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.

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.

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 1.3.1

Process Flow in Main Plant Process Flow for Incoming Raw Material, Main Plant

Start

Incoming raw material (such as natural latex, synthetic latex, chemicals & packaging materials) QA Not Approve. Raw materials need to be returned to suppliers and exchange with new lot of raw materials.

QA Inspection

Quality inspected by QA (Quality Assurance) Department

QA Approved

Store in warehous e

Release to manufacturing use, once requested.

End 1.3.2 Glove Process Flow Chart


START

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 PACKING FAIL FINAL PACK Label Printer

QA LOT RELEASE PASS

WIP

CONTAINER LOADING

WAREHOUS E SALES ORDER

SHIPPING INVOIS

END

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1.4

Organization Chart 1.4.1 Regent Hospital Products (Kulim & Kuala Ketil)

11

1.4.2 Regent Hospital Products (Batang Kali)

12

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


Scope of Work / Task a) Good Manufacturing Practice: Implementation of 5S b) 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. a) Inspection of incoming formers in physical lab.

Department Engineering

Quality Assurance 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

Automated Glove (AG) Dipping Plants

chemical used. a) Understand the Automated Glove Dipping Process and function of each chemical used. b) Troubleshooting on AG Faults

CHAPTER 2 ENGINEERING DEPARTMENT 2.1 2.1.1 Good Manufacturing Practice 5S Introduction 14

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 Seiri Seiton Seiso Seiketsu Shitsuke Translated in English Sort Straighten Shine Standardize Sustain Definitions Separate what is needed in the work area from what is not, eliminate the unnecessary materials. Arrange the necessary items in an orderly fashion, so that they are easily accessed. Clean the workplace to clean the floor and equipment tidy. Look for ways to keep it clean. Clearly identified and stored the items in designated area 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 18

2.2.1

Purpose of Process Water Treatment System

The process water from treatment system is supplied to dipping stations (AG processing line), Process 1, Process 2, and Compounding. In order to save cost, company is using the both the underground water and council water. Both the underground water and council water is treated and sterilized, before it is supplied to the mention department, to prevent contamination of the gloves produced. The chlorine level, iron level and pH level of process water produced must meet the specified range.

2.2.2

Process Flow Chart of Process Water Treatment 19

Incoming Water from Underground

Incoming Council Water

Filter Vessel

Council Water Tank

Clarifier

Reagent 2 Dosage

Reagent 1 Dosage

Filter Vessel (x3) Raw Water Tank Final Filtration System (x4)

Filter Vessel (x3) Water Holding Tank

Sterilization System (x4)

Reagent 3 Dosage

Filter Vessel (x2)

Process Water Storage tank

Tube Well Over Flow Tank

Process Water Elevated Tank

Filter Vessel Used by AG, Process 1, Process 2, Compounding & Boiler

Soft Filter Vessel (x6)

Final Filtration System for Tube Well Water (x3)

2.2.3

Description of the Process Water Treatment System 20

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 21

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 22

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. 23

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. <OFF> 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 24

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

Incoming Council Water

Reagent 9

Reagent 10 Water Feed Tank

Burner

Boiler

Heated Water

Steam Produced

High Temperature Gas produced

Supplied to AG, Process 1, Process 2 & Air Compressor

Economizer

Chimney Steam which condensed to water

2.3.3

Description of Boiler Operation 25

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 fine particle 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 26

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


Flue Gas supplied to Economizer Double Spring Safety Valve Main Hole Main Steam Valve Check Valve

Steam supplied to Plant Burner Second Pass Tube Heated Water

First Pass Tube

Force Draught Fan

Rotatory Cup

Wet Back

Blow Down

Figure 10: Diagram of Internal Part of Boiler

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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 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. 29 :

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

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

High Temperature Flue Gas is passed through the Steel Tubes High Temperature Flue Gas produced from Boiler

Steel Tubes

Water from Water Feed Tank is Fed to Steel Tubes

Heated Water is fed to Boiler.

Low Temperature Flue Gas Exit through Chimney

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. 31

2.4 2.4.1

Process of Air Compressor Operation 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

Air is sucked from surrounding

Air Compressor

Air Receiver Vessel

Auto Drain

Oil tank

Separator

Water tank

Filter Vessel

Refrigeration Dryer DOE Filter Vessel (x2)

Air outlet Waste Water Treatment plant

Ready to be used

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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 2.5.1

ISO 13485 & American Food and Drugs Administration (FDA) ISO 13485

ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. ISO 13485:2003 is recognized by the European Union, Japan, Australia, Canada and many other countries. Requirements to comply with ISO 13485 a) Risk management throughout the product life cycle b) Control of non conforming products c) Document data control: Personal: Health and cleanliness of clothing Environmental control in manufacturing plant Cleanliness of product Maintenance of PLC (Programmable Logic Controller), electrical and mechanical moving parts Records of installation (process validation protocol for any software or equipment installed) and checking performed Documents for the validation of computer software used in process control must be established and maintained d) Establish and maintain a documented feedback system to provide early warning of quality problem, and for input of the corrective or preventive action system Medical device manufacturers must audit their quality systems on a regular basis to ensure compliance with the appropriate regulations and standards. Failure to do so can result in poor product quality, lack of process improvement and loss of certification when audited by external party (on a regular basis). 34

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-thecounter pharmaceutical 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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2.6 2.6.1

Similarities of Requirements from ISO 13485 & FDA: Process Validation Protocol 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 in: Quality Assurance Engineering Manufacturing Research & Development Purchasing/Planning Members of the validation team

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

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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 38

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 3.1.1 Physical Lab 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

41

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 4.1.1 Compounding 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 developmental birth 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

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 10 o, 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.

Motor

Extended Metal

10o

Stirring Shaft

Tank Diameter

Stirrer

Figure 10: Diagram shows the lifted stirrer shaft of mixing tank 44

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. PRODUCT: LOT NO.: MATERIAL SUBJECT TO: EXPELLER NO: STANDARD QUANTITY (KG) SPECIFICATION ( KG) PREPARED BY: CHECKED BY: ISSUE DATE: DOCUMENT NO:

SAIZ: LOT NO. OF MANUFACTURER:

LITRE MATERIAL LOT NO.:

MANUFAC. DATE: WEIGHED QUANTITY (KG)

WEIGHED BY: PROCEDURES: 1. 2. 3. 4. 5. DOCUMENTATION COMPLETED: CHECKLIST (MARK AS ) PERFORMED BY:

CHECKED BY: CHECKED BY:

CHECKED BY:

Table 4: Template for SOP in Bahasa Melayu


REGENT HOSPITAL PRODUCTS SDN. BHD. DISEDIAKAN OLEH: DISEMAK OLEH: TARIKH DIKELUARKAN: NO. DOKUMEN:

45

PRODUK: NO. LOT: BAHAN

SAIZ: NO. LOT PEGELUAR:

LITER NO LOT BAHAN: KUANTITI PIAWAI (KG)

SUBJEK KEPADA: NO. EKSPELER TARIKH SPESIFIKASI ( KG) DIKELUARKAN KUANTITI DITIMBANG (KG)

DITIMBANG LANGKAH-LANGKAH: 1. 2. 3. 4. 5. 6. 7. 8. ADAKAH SEMUA DISI DENGAN LENGKAP: SENARAI SEMAK (TANDAKAN ) OLEH: DILAKUKAN OLEH:

DISEMAK OLEH: DISEMAK OLEH:

DISEMAK OLEH:

4.2 4.2.1

Waste Water Treatment 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

Waste Water from Production

Reception Tank (Incoming of Raw Waste Water)

Reception Tank (Incoming of Chemical A Waste Water)

Reagent 4 & Primary Treatment Tank Reagent 5 47

Dosage Reagent 8

Balancing Tank 1

Chemical treatment Process Tank

Dosage
Balancing Tank 1 Treated Water

Reagent 6 Dosage

Flocculation Tank

Sludge Collection Tank

Settlement Tank (x2) Filter Press Filter Feed Tank Sludge Dryer Filter Media (x5) Bulk Packing Water Collected

Reagent 7 Dosage Bacteria & Urea Dosage

pH Adjustment Tank

Bio Feed Tank

Send to DOE Disposal

Biological Tower (x2)

Humus Tank

Humus Pit

Final Discharge to Common Drain

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 48

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. 49

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 flow rate 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 50

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 bag which are durable and which are able to prevent spillage or leakage into the environment, since it is a toxic waste.

4.3 4.3.1

Automated Glove (AG) Dipping Plant Purpose of AG Dipping Plant and Former Loading 51

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


Reagent B Former Cleaning Dipper Initial Beading Station

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Reagent A Former Cleaning Dipper

Ink Jet Printer

Leaching Station Reagent C Former Cleaning Dipper Reagent F Dipper Former Brushing Station

Reagent F Rinse Tank

Flood wash Station

Pre Reagent G Dryer

Preheat Dipper & conditioning formers with a layer of Reagent D Reagent E Dipper

Reagent G Dipper

Final Beading Station

Vulcanizes (x8) Reagent E Dryer Pre Strip Tank Latex Dipper Stripping Station Pre Bead Oven

4.3.3

Description of AG Dipping Plant

Reagent B Former Cleaning Dipper 53

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

54

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 55

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 56

Defects on Gloves: 1. Thick Bead 2. 3. 4. Thin Bead Torn Bead Holes

Solutions: 1. Adjust the alignment of rollers. 2. Check latex level in Latex Dipper, repair or change the level sensors. 1. Adjust the alignment of rollers. 2. Check latex level in Latex Dipper, repair or change the level sensors. 1. Change the rollers. 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. 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.

5.

Dirty Sport On gloves

4.4 4.4.1

Process 1 Washing and Drying Process

57

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

58

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 59

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: 60

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 62

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

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