Study-Unit Description

Study-Unit Description


CODE PHR1613

 
TITLE Pharmaceutical Process Technology 1

 
UM LEVEL 01 - Year 1 in Modular Undergraduate Course

 
MQF LEVEL 5

 
ECTS CREDITS 8

 
DEPARTMENT Pharmacy

 
DESCRIPTION Introduction to the pharmaceutical industry with an insight to the Good Manufacturing Principles requirements in terms of premises, equipment, personnel, training requirements for a manufacturing site.

Pharmacopoeial tests used in industry including Disintegration Test, Dissolution Test, Uniformity of weight and Uniformity of content are presented.

Microbiology aspects in terms of different types of microorganisms, classification and methods of identification of microorganisms are described. Bacterial physiology, growth and multiplication and culturing are discussed. Development of immunisation and anti-infective agents is introduced.

Study-unit Aims:

- To introduce the student to the different sections and to the procedures of the Pharmaceutical Industry.
- To establish the basic principles of the Pharmacopoeial tests commonly used to test tablets, capsules and other pharmaceutical dosage forms.
- To establish and consolidate general principles of pharmaceutical microbiology.
- To introduce the student to microbial structure, taxonomy, growth, replication and the laboratory examination of micro-organisms.
- To expose the student to the implication of micro-organisms in disease states and the role of anti-infective agents.

Learning Outcomes:

1. Knowledge & Understanding:

By the end of the study-unit the student will be:
- Able to describe hierarchy and organisation of the Pharmaceutical Industry;
- Able to appreciate the training and management requirements within the Pharmaceutical Industry;
- Able to list the basic Pharmacopoeial tests;
- Able to describe the process of packaging;
- Familiar with basic principles of microbiology;
- Knowledgeable of the role of micro-organisms in infectious diseases;
- Knowledgeable on the effect of anti-infective agents.

2. Skills:

By the end of the study-unit the student will be able to:
- Attend the Industrial sector with knowledge on its function;
- Compare pharmacopoeial tests on different dosage forms and explain requirements for packaging;
- Identify different types of micro-organisms;
- Describe the impact of micro-organisms in the food industry, pharmaceutical industry and hospital setting.

Main Text/s and any supplementary readings:

- Sharp J. Quality in the Manufacture of Medicines and other Healthcare Products. London: Pharmaceutical Press; 2000.
- Aulton ME, editor. Aulton’s pharmaceutics the design and manufacture of medicines. Edinburgh: Churchill Livingstone; 2007. ISBN 978-0-443-10108-3.
- British Pharmacopoeia Commission Secretariat of the Medicines and Healthcare products Regulatory Agency. British Pharmacopoeia. London: The Stationery Office; 2011. ISBN 9780113228492.
- Hugo WB, Russell AD. Pharmaceutical Microbiology. Oxford: Blackwell Science. 1998. ISBN 0-632-04196-X.
- Greenwood D, Slack R, Peutherer J, Barer M, editors. Medical Microbiology: A guide to microbial infections: Pathogenesis, immunity, laboratory diagnosis and control. London: Churchill Livingstone. 2007. ISBN 9780443102103.
- Mohr ME. Standards of Practice for the Pharmacy Technician. 1st ed. USA: Lippincott Williams & Wilkins; 2009.
- Moini J. Comprehensive exam review for the pharmacy technician. New York: Thomson Delmar Learning; 2005.

 
STUDY-UNIT TYPE Lecture and Tutorial

 
METHOD OF ASSESSMENT
Assessment Component/s Assessment Due Sept. Asst Session Weighting
Examination (3 Hours) SEM2 Yes 100%

 
LECTURER/S Andrew John Cauchi
Clinton Muscat
Nicolette Sammut Bartolo
Mark Cilia
Lara Marie Giudice
Mark Sean Zammit

 

 
The University makes every effort to ensure that the published Courses Plans, Programmes of Study and Study-Unit information are complete and up-to-date at the time of publication. The University reserves the right to make changes in case errors are detected after publication.
The availability of optional units may be subject to timetabling constraints.
Units not attracting a sufficient number of registrations may be withdrawn without notice.
It should be noted that all the information in the description above applies to study-units available during the academic year 2023/4. It may be subject to change in subsequent years.

https://www.um.edu.mt/course/studyunit