COURSE OUTLINE

Kulliyyah

/

Department

Pharmaceutical Technology

Programme

/ B. Pharmacy
Course Title / Sterilization and Aseptic Technology
Course Code / PHM 4122
Status / Core course
Level / 4000
Credit Hours
Contact Hours / 2
Lecture = 21, Practicals = 3 x 3,
Visit = 1 x 3, Tutorial = 3
Total = 36 hours
Pre-requisites
(if any) / Nil
Co-requisites
(if any) / Nil
Teaching Methodology / Lecture
Tutorial
Practical/Laboratory
Visit
Method of Evaluation / Mid-semester assessments 40%
Practical/Report 5%
MCQs 10 questions 10%
Duration: 20 minutes
Short Essays 3 out of 4 questions 15%
Long Essays 1 out of 2 questions 10%
Duration: 1 hour 30 minutes
End of semester assessments 60%
Practical/Reports 10%
MCQs 15 questions 15%
Duration: 30 minutes
Short Essays 3 out of 5 questions 15%
Long Essays 2 out of 4 questions 20%
Duration: 2 hours
Course Coordinator
Instructor(s) / Dr. Mohamed Awang
Dr. Nasreldin El Hadi
Dr Tajuddin Akasah (BPFK)
Mr. Mizan Ab. Wahid (MINT)
Semester Offered / 1
Course Objectives / At the end of the course, students should be able to understand the following:
1.  Basic principles of sterilisation, various sterilisation techniques and their application in manufacture of sterile pharmaceutical products
2.  Basic principles of aseptic manufacture of sterile products that are not able to be terminally sterilised
3.  Sterility and pyrogen testings
4.  Control and work procedures of clean room/laminar flow work station
5.  Environmental Monitoring
Course Synopsis / This course introduces the principles and practice of sterilisation and aseptic processing in the manufacture of sterile products.
The requirements on the control of and the procedures to work in a clean room or clean work station will also be introduced.
Students will be learning about the elements of factory (or work station) hygiene and good manufacturing practice.
Course Outlines / It covers the principles and practice of sterilisation, tests of sterility, work procedures in clean room environment, and the aseptic handling of sterile products.
During the course, a visit will be arranged to enable students to observe the unit operations involved in the production of sterile pharmaceuticals or items which include sterilisation, aseptic handling and packaging.
Weeks
1
2
3
4
5
6
7
8
9
10
11
12
13
14 /

Topics

Introduction:
Definition, Overview of terminal sterilization and aseptic processing
Sterile pharmaceutical products; types and uses,
effects of contamination
Principles of sterilization, definition of sterility, bioburden, sensitivity of microorganisms to sterilization
Heat sterilization, design and operation of autoclave; design and operation of oven
Practical 1: Terminal Sterilization (filtration, autoclaving) and sterility test
Non-heat sterilization:
Gas (ETO, VPHP),
Non-heat sterilization:
Radiation
Non-heat sterilization:
Filtration
Validation and Routine Monitoring of Sterilisation Process
Tutorial 1
Factory Hygiene:
Essentials of GMP 1
Factory Hygiene:
Essentials of GMP 2
VISIT
Manufacturer of Sterile Pharmaceutical Products
Principles of Aseptic Processing
Media fills
Sterility tests, media,
New microbial test methods (radiometric, etc)
Pyrogen: sources of, prevention, monitoring of,
(rabbit, LAL and QCL methods, etc)
Practical 2: Pyrogen test (rabbit/LAL/QCL)
Tutorial 2
Disinfection,
Types of Disinfectants I
Types of Disinfectants II
Design and operation of aseptic room, class of clean rooms
Types of airflow:
uni-directional, non-unidirectional, mixed flow, types of LAF cabinets, handling of cytotoxic (biohazard) products
Practical 3: Aseptic process (aseptic filling) and sterility test
Environment monitoring,
Particles monitoring (coulter counter), microbial monitoring (exposed plates)
Isolator Technology
BFS technology in isolator
Production of sterile water for injection,
-regulatory standards, purified water, water for injection, conductivity, total organic carbon
-design of water purification system
-source water, treatment, storage and distribution
Principles of CIP/SIP
Tutorial 3 / References
Reference 1: Chapter 19, pp. 333
Lecturer: Dr. Mohamed
Reference 2: Chapter 21, pp. 410; Reference 4, Chapter 1, pp 1
Lecturer: Dr. Mohamed
Reference 2: Chapter 20, pp. 385
Lecturer: Dr. Nasreldin
Reference 2: Chapter 20, pp. 390
Lecturer: Dr. Mohamed
Mohamed/Nasreldin
Reference 2: Chapter 20, pp. 398
Lecturer: Dr. Mohamed
Reference 2: Chapter 20, pp. 401
Lecturer: Dr. Mohamed
Reference 2: Chapter 20
pp. 405
Lecturer: Dr. Mohamed
Reference 3: pp. 554
Reference 2: Chapter 23, pp 441
Lecturer: Dr. Mohamed
Mohamed/Nasreldin
Reference 1: Chapter 5, pp. 59;
Reference 2: Chapter 22, pp. 426
Lecturer: Dr. Tajuddin (BPFK)
Reference 1: Chapter 5, pp. 59;
Reference 2: Chapter 22, pp. 426
Lecturer: Dr. Tajuddin (BPFK)
Mohamed/Nasreldin
Reference 2: Chapter 22, pp. 430
Reference 3: pp 561
Reference 4: Chapter 3, pp 53
Lecturer: Dr. Mohamed
Reference 2: Chapter 23, pp. 446
Reference 4: Chapter 7, pp 157
Lecturer: Mr. Mizan, MINT
Reference 3: pp 527
Lecturer: Mizan, MINT
Mohamed/Mizan
Mohamed
Reference 2: Chapter 10, pp. 201-288
Lecturer: Dr. Nasreldin
Reference 2: Chapter 10, pp. 201-288
Lecturer: Dr. Nasreldin
Reference 1: Chapter 20 pp. 363
Reference 5: Chapter 42 pp 686
Lecturer: Dr. Mohamed
Reference 3: pp. 569
Lecturer: Dr. Mohamed
Mohamed/Nasreldin
Reference 4: Chapter 2, pp 23
Lecturer: Dr. Mohamed
Reference 1, pp 389
Lecturer: From Industry
Reference 6: pp. 342
Lecturer: From Industry
Reference 7: Chapter 17, pp 449
Reference 8: pp 260-262
Lecturer: From Industry
Mohamed/Nasreldin
References / Required:
1.Quality and Manufacture of Medicines and Other Healthcare Products (2000), John Sharp, Pharmaceutical Press, London
2. Pharmaceutical Microbiology (2002), WB Hugo and AD Russel (ed), Blackwell Science, UK
3.The Pharmaceutical Codex (1994), Walter Lund (ed), The Pharmaceutical Press, London
4. Microbiological Contamination Control in Pharmaceutical Clean Room (2004), Nigel Halls (ed), CRC Press, Boca Raton, Florida
5. Pharmaceutics: The Science of Dosage Forms (1988), ME Aulton, Churchill Livingstone, London
6. Pharmaceutical Dosage Forms: Parenteral medications, Vol. I (1992), KE Avis et al (eds), Marcel Dekker Inc., New York.
7. Freeze Drying/Lyophilization of Pharmaceutical and Biological Products (2004), Louis Rey (ed), Marcel Dekker
Inc., New York
8. Pharmaceutical Dosage Forms: Parenteral medications, Vol. 3 (1993), KE Avis et al (eds), Marcel Dekker Inc., New York.
Recommended:
1. Modern Pharmaceutics 3rd Edn (1995), GS Banker, CT Rhodes, Marcel Dekker.
2. Achieving sterility in Medical and Pharmaceutical Products ,1st Edn (1994), NA Halls, Marcel Dekker.
3. Guidance for Industry: Sterile Drug products Produced by Aseptic processing-Current Good Manufacturing Practice (2004), US Department of Health and Human Services, Food Drug Administration, USA.
(http://www.fda.gov/cder/guidance/
index.htm)
4. Guide to Good Manufacturing Practice for Medicinal products (2004), PIC/S Secretariat, Geneva
(http://www.picscheme.org)
Proposed Start Date ( Semester) / Year 2005/2006 (Semester 1)
Batch of Students to be Affected / Year 2005/2006 and onward