University of Jordan/Faculty of Pharmacy
Department of Pharmaceutics and Pharmaceutical Technology
Course Syllabus
Course Information:
Course Title: Pharmaceutical Microbiology II
Course Code: 1202441
Prerequisite: Pharmaceutical Microbiology I ( 1202341)
Credit Hours: 2
Course Instructor
Name
Office No.
Office Phone
Office Hours
Dr Amal Al- Bakri
215 A
23330
To be announced
http://www.ju.edu.jo/sites/academic/agbakri/default.aspx
E-mail Address
agbakri @ ju.edu.jo
Course Objectives:
1. Introduce the students for the concept of sterilization, disinfection, antisepsis and preservation.
2. Introduce the students for the different chemical and physical methods used to control microbial contamination.
3. Introduce the students for the methods used for the evaluation of antimicrobial efficacy and factors affecting it .
4. Introduce the students for the principle of controlled environment, quality control and quality assurance.
5. Introduce different applications of microorganisms in pharmaceutical sciences.
Intended Learning Outcomes for Microbiology II
A- Knowledge and Understanding
1. know the meaning of biocide and the difference between biocide and antibiotic
2. Know the meaning of disinfection, antisepsis, and preservation process
3. Know the meaning of bacteriocidal, bacteriostatic and chemical sterilants.
4. Know the different biocides in use their chemical nature, their spectrum of activity and their mode of actions.
5. Know the different chemical and physical factors that affect the antimicrobial activity
6. know the effect of microorganisms on the spoilage of pharmaceutical preparations
7. Know the principle of preservation
8. Know the principle of sterilsation
9. Know the different methods used for sterilization
10. Know the principle of the controlled environmewnt (aseptic and clean room facilities)
11. Know the different quality control and quality assurance measures for the control of microbial contamination
12. Know the different in vitro tests used to evaluate the efficacy, the potency and the capacity of different
antimicrobial agents
B. Cognitive and Intellectual Skills
1. Decide the best biocide to be used in different practical situations
2. Interpret the results of the different test used to evaluate the antimicrobial efficacy
3. Calculate different the temperature and dilution coefficients of different antimicrobial
agents and interpret the results towards their effect on the antimicrobial efficacy
4. Allocate the different measures to be taken to obtain an aseptic and clean environment
and monitor those measures
5. Decide the appropriate test to be performed on different pharmaceutical preparation so as to measure their
microbial quality
6. Decide the most suitable sterilization method to be used for each particular pharmaceutical preparation
C. Practical Skills
1. Perform different qualitative and quantitative tests for the evaluation of the bacteriostatic and bacteriocidal
activity of different antimicrobial agents towards different microorganisms
2. Perform test to measure the antimicrobial potency.
3. Perform sterility test using aseptic methods and interpret the results
4. Design of the appropriate autoclave cycle to obtain the optimum and acceptable lethality.
D. Transferable Skills
1. Communicate effectively with the drug manufacturing bodies concerning GMP for microbial quality monitoring
2. Gain basis for the design of different disinfection policies in hospitals or pharmaceutical industry
3. Develop the skills of self-learning
1
University of Jordan/Faculty of Pharmacy
Department of Pharmaceutics and Pharmaceutical Technology
Teaching Methods: Lectures, Self Readings and Homeworks
Tests and Evaluations:
Quiz and Self reading*1 (10%)
Mid-term exam
(30%)
2
Quizand Self reading*
(10%)
Final Exam
(50%)
Time table for exams will be announced latter
Self reading*1: Chapter 17: Antimicrobial combinations and system. Disinfection policies. , pp 303-304
Self reading*2: Chapter 19: Sterile Pharmaceutical Products:Dressings, Implants, Absorbable haemostats,
Surgical ligatures and sutures and Instruments and equipment pp 333-336.
Course Contents and Schedule:
Number of Lectures
Topics
1- Disinfection and Antisepsis
(10 lectures)
Definition
Mode of action of disinfectants
Dynamics of disinfectant
Factors affecting activity of disinfectants
Evaluation of disinfectants and antiseptics
Disinfectants and antiseptics in common use
2. Microbial Contamination and Spoilage of Pharmaceutical Products
( 6 lectures)
Introduction
Spoilage of pharmaceutical products
Sings of spoilage
Consequences of using spoiled product
Causes and factors influencing microbial spoilage
Mid –Term exam
3. Control of Microbial Contamination and Spoilage
Good manufacturing practice (GMP)
Proper formulation and storage conditions
Preservation of pharmaceutical products
Preservatives commonly used in pharmacy
Factors influencing preservation
Determination of preservative efficacy
4. Sterilisation
Introduction
Dynamics of microbial kill process
Sterilisation methods, instruments and operation
Sterilisation control and sterility testing
Sterile pharmaceutical products
5. Aseptic Area and Aseptic Processing
Definitions
The need for aseptic techniques and aseptic areas
Features of aseptic areas, design, facilities and control
6. Applications of Microorganisms in Pharmaceutical sciences
Final Exam
References
Hugo, W.B and Russell, A.D. Pharmaceutical Microbiology. Seventh Edition
Important Regulations:
The University Regulations are applied
2
( 6 lectures)
( 6 lectures)
(2 lectures)
( 2 lectures)