FAKULTI of ENGINEERING TECHNOLOGY

1

Course Code and Name

BTP2362 CONTAMINATION CONTROL & CLEAN ROOM

2

Semester and Year Taught

Semester 1 Year 2

3

Program Level/Category

Degree/Engineering Technology

4

Unit

2 Credits

5

Prerequisite Course

Nil

6

Contact Hours

Lecture:

Tutorial:

Laboratory:

2 units

0 unit

1 unit

7

Course Synopsis

This module aims to provide the student with in-depth knowledge to understand and work clean room environment with clear concepts in contamination control

8

Course Outcomes

By the end of semester, students should be able to:

CO1

CO2

CO3

CO4

Introduction and basic concepts of clean room and contamination control

Principles, problems and equipment related to clean room and contamination control

Ability to present as individuals in matters related to contamination control and cleanroom concepts

Ability to monitor and decontaminate the clean-room environment.

9

Assessment Methods

Distribution (%)

CO1

CO2

CO3

CO4

Quiz

5

×

×

Test

10

×

×

Assignment/Presentation

5

×

Laboratory

30

×

Laboratory Report

10

x

Final Examination

40

×

×

Total

100

10

Learning References

1.Introduction to contamination controla dn clean room technology. Matts Ramstorp. Ist edition. 2000 Wiley, Germany. ISBN: 3-527-30142-9

2.Cleanroom Technology. Fundamentals of Design, testing and Operation. William Whyte Wiley. 2nd edition. 2010. ISBN:978-0-470-74806-0

3.A. Miller et al Clean-room technology and procedures, 1992 [ISBN: 0961388056]












UNIVERSITI MALAYSIA PAHANG

Relationships between Program Outcomes (PO) with Course Outcomes (CO)

Course Outcomes

PO1

PO2

PO3

PO4

PO5

PO6

PO7

PO8

PO9

PO10

PO11

PO12

CO1

Introduction and basic concepts of clean room and contamination control

x

CO2

Principles, problems and equipment related to clean room and contamination control

x

CO3

Ability to present as individuals in matters related to contamination control and cleanroom concepts

x

CO4

Ability to monitor and decontaminate the clean-room environment

x

.

Assessment

%

CO1 PO1

CO2PO3

CO3 PO8

CO4 PO11

Quiz

5

X

x

Test

10

X

x

Assignment/Presentation

5

X

Laboratory

30

x

Laboratory Report

10

x

Final Examination

40

X

x

Total

100

Program Outcomes (PO)

PO1

Ability to apply knowledge of mathematics, science, engineering fundamentals and pharmaceutical engineering technology principles to define and applied pharmaceutical engineering technology procedures, processes, systems or methodologies.

PO2

Ability to solve broadly-defined pharmaceutical engineering technology problems systematically to reach substantiated conclusions by using appropriate tools and techniques.

PO3

Ability to design solutions for broadly-defined pharmaceutical engineering technology problems, and to design systems, components or processes to meet specified needs with appropriate consideration for public health and safety, as well as cultural, societal, environmental and sustainability concerns.

PO4

Ability to plan and conduct experimental investigations of broadly-defined pharmaceutical engineering technology problems by using data from relevant sources.

PO5

Ability to select and apply appropriate techniques, resources and modern pharmaceutical engineering technology tools, with an understanding of their limitations.

PO6

Ability to function effectively as individuals, and as members or leaders in diverse technical teams.

PO7

Ability to communicate effectively with the pharmaceutical engineering technology community and society at large.

PO8

Ability to demonstrate an awareness of and consideration for societal, health, safety, legal and cultural issues and their consequent responsibilities.

PO9

Ability to demonstrate an understanding of professional ethics, responsibilities and norms of pharmaceutical engineering technology practices.

P10

Ability to demonstrate an awareness of management, business practices and entrepreneurship in the field of pharmaceutical engineering technology.

P11

Ability to demonstrate an understanding of the impact of pharmaceutical engineering technology practices, taking into account the need for sustainable development

P12

Ability to recognize the need for professional development and to engage in independent and lifelong learning in the field of pharmaceutical engineering technology.



Chapter

Week

Topic

Topic Outcomes (TO)

CO

PO

Delivery Methods



1

1

Clean-rooms

·Clean-room classifications and standards

·Air filtration analysis

·Classify the types of clean rooms

·Analysis of air filtration concepts

CO1

PO1

Lecture


CO2

PO3


2

2

Materials and equipment

·Room components

·Room accessory

·Corridor structure

·Distinguish room components (wall, floor, celing) material of construction

·Locate the positions of showers and cabinets

·Predict the corridor movement

CO1

PO2

Lecture

Asssignment


CO2

PO3


CO3

PO8

 

3

3

Clean Room Practices

·Personal restrictions

·Entry points

·SOPs

·Categorize clothing for staff and contractor

·Critical control of clean-room entrance practices

·Standard Operating Procedures for clean-room work.

CO1

PO1

Lecture

Asssignment


CO2

PO3


CO3

PO8

 

4

4-5

Contamination Monitoring

·Materials entry supervision

·Air and surface

·Warning signals

·Monitoring the quality of materials entering the clean-room

·Monitoring air and surface quality in clean-rooms.

·Clean-room standards for designating normal, alert and alarm levels.

CO1

PO1

Lecture

Asssignment


CO2

PO3


CO3

PO8

 

5

6

Working area sortment

·Decontamination methods

·Air pressure segregation

·Personal working habits

·Introduction to specialized methods of cleaning

·Introduction to positive air pressure environments

·Review of personal behavior in clean rooms

CO1

PO1

Lecture

Asssignment


CO2

PO3


CO3

PO8


6

7-8

Contamination Categories

·Types

·Types of physical contaminants

·Types of chemical contaminants

·Types of biological contaminants

CO1

PO1

Lecture

Asssignment


CO2

PO3


CO3

PO8


7

9

Cleaning Equipment

·equipment selection

·equipment criteria

·Selection of cleaning items of equipment in use in the pharmaceutical manufacturing sector.

·Criteria used in the selection of appropriate cleaning agents and equipment

CO1

PO1

Lecture

Asssignment


CO2

PO3


8

10

Cleaning reagents

Cleaning agents selection

Cleaning agent criteria

·Selection of cleaning agents in use in the pharmaceutical manufacturing sector.

·Criteria used in the selection of appropriate cleaning agents

CO1

PO1

Lecture

Asssignment


CO2

PO3


9

11

Channelized cleaning

·Effective cleaning

·Documentation

·Principles of effective cleaning

·Writing standard operating procedures describing controlled cleaning practices

CO1

PO1

Lecture

Asssignment


CO2

PO3


10

12

Air Quality Monitoring

Experiment

·Air particulate matter in lab environment

·Air particulate matter in outside lab environment

CO4

PO11

Lecture


11

13

Air Capture Hood Experiment

·In normal ambient condition

·In chemical induced contamination condition

·In biologicalinduced contamination condition

CO4

PO11

Lecture


12

14

Revision