Abdel Naser Zaid
Nature of Work
University President
Email Address
[email protected]

Abdel Naser Zaid

Nature of Work
University President
Email Address
[email protected]
Pharmaceutical sterilization & Quality Assessment - 7730472
Course Title
Pharmaceutical sterilization & Quality Assessment
Course Number
Instructor Name
Abdel Naser Zaid
Contact Information
[email protected]
Semester(s) and academic year(s)
First Semester 2018
Compulsory / Elective
Course Description

The sterilization course covers the entire range of sterilization processes utilized in the pharmaceutical and medical device industries. Sterilization methods, validation practices and related subjects to be covered include: Prerequisites for Sterilization; Microbiology of Sterilization; Use of Biological Indicators; Steam sterilization; Terminal Sterilization using Steam; Dry heat sterilization and depyrogenation; Gas, sterilization, Radiation sterilization; Filtration sterilization.

The course aims to review the quality assurance aspects in the manufacture and control of sterile products and to describe the requirements for routine monitoring and control of sterilization.

Course Objectives
  • To emphasize the knowledge of the student about the most important techniques involved in this field.
  • To comprehend the skills necessary in order to work in sterile conditions.
  • To design a unit of sterile area which should be installed in pharmaceutical industry, hospital pharmacy or surgery room.
Intended learning Outcomes and Competences

Upon completion of the course, the student should be able to:


A.        Knowledge and understanding:

A.1. Recognize the various sterilization methods available in the pharmaceutical industry.

A.2. List the advantages and disadvantages of each sterilization method.

A.3. Identify the factors that affect the final quality of a sterilized dosage forms.

A.4. Describe the packaging materials used in parenteral and ophthalmic prepation and their limitations in each sterilization method.

B- Intellectual skills:

B.1. Demonstrate the pharmaceutical skills necessary for the sterilization of different pharmaceutical dosage forms.

B.2. Evaluate how the quality of the sterilized products is affected by changes in the sterilization method.

C- Professional Skills:

C.1. Select an appropriate sterilization method for a specific product.

C.2. Perform and prepare a sterilized product in a hospital setting.

D- General and transferable skills:

D.1.     Perform online computer searching.

D.2.     Work cooperatively in a team on projects.

D.3.     Learn how to use external and supplementary references to explore in depth a given topic.

D.4.     Communicate- by presentation- scientific information to other healthcare professionals.

Textbook and References


Assessment Criteria
Activity Percent (%)