MSc Pharmaceutical Industrial Advanced Training (PIAT) / Course details

Year of entry: 2020

Course unit details:
Antimicrobials (PMAT 8)

Unit code PHAR71370
Credit rating 15
Unit level FHEQ level 7 – master's degree or fourth year of an integrated master's degree
Teaching period(s) Variable teaching patterns
Offered by Pharmacy
Available as a free choice unit? No

Aims

This unit aims to cover the three broad areas discussed above, namely;
(i) Antibiotics and Antimicrobial Chemotherapy;
(ii) Disinfection and Disinfection Validation;
(iii) Preservation of Sterile and Non-Sterile Pharmaceuticals; 
and to examine the regulatory aspects relevant to each within the pharmaceutical industry. Aspects of Current Good Manufacturing Practice (cGMP), process validation and efficacy testing as well as laboratory evaluation of antimicrobial agents are covered in the relevant units.

Syllabus

Unit 1 Introduction to Module 8:
Provides a general introduction to the module and the areas which will be covered in the course of studying module 8.
 
 
Unit 2 Antibiotics: Major Classes and Modes of Action:
In this unit the major classes of currently used antibiotics is discussed, alongside their mode of action and the mechanisms by which bacteria have evolved resistance to their action. Antibiotics have been group together by family and by bacterial target site. Therefore, the learning objectives of this unit are as follows
(i) To become familiar with the major antibiotic classes
(ii) To understand the concept of selective toxicity with reference to the modes of action and targets of each class of antibiotic agent
(iii) To gain an appreciation of the mechanisms by which bacteria elaborate resistance to antibiotics
(iv) To appreciate the sources of antibiotics, namely, natural, semisynthetic and synthetic agents
 
Unit 3 Laboratory Evaluation of Antimicrobial Agents:
In this unit, the standard assays for the evaluation of antimicrobial agents is discussed in detail. A description of microbial biofilm formation and factors contributing to their tolerance to antimicrobial challenge is given, alongside methods for evaluation of biofilm susceptibility to antimicrobial agents. Finally, specific current GMP regulations pertaining to antibiotics and APIs prepared via processes involving cell culture or classical fermentation. The learning objectives of this unit are therefore:
(i) To understand the standard methods for determination of antimicrobial activity of antimicrobial agents
(ii) To gain an appreciation for the process of microbial biofilm formation and the features of the biofilm
(iii) To become familiar with the terms minimum inhibitory concentration, minimum bactericidal concentration and minimum biofilm eradication concentration
(iv) To understand the concept synergy and antagonism between antimicrobials in planktonic and biofilm assays
(v) To become familiar with current GMP guidance and regulations regarding antibiotic manufacture, specifically relating to dedicated facilities and antibiotics/APIs manufactured by processes involving cell culture and/or classical fermentation steps
 
Unit 4 Laboratory Evaluation of Disinfectants:
In this unit, the various types of disinfectant, their mode of action and advantages/disadvantages will be discussed. The factors affecting the activity of disinfectants will also be considered. Finally, the laboratory methods for evaluation of disinfectant activity will be described for the
various types of agent. The learning objectives of this unit are therefore:
(i) To become familiar with the main classes of disinfectant, their modes of action and advantages and disadvantages associated with their use
(ii) To gain an appreciation of the circumstances under which disinfectant activity may be attenuated
(iii) To use this information to guide rational selection of disinfectants
(iv) To understand the standard laboratory methods for evaluation of disinfectant agents and the design of such standard methods to permit evaluation of disinfectant attenuation
 
Unit 5 Disinfectants: Process Validation and Current Regulatory Requirements:
In this unit, the practical considerations for disinfectant selection and disinfectant validation are discussed. The disinfectant efficacy tests involved in disinfectant process validation are discussed, alongside current GMP relating to disinfectants/disinfection and regulation of disinfectant/biocide use in Europe. The learning objectives of this unit
are:
(i) To understand the factors influencing the selecti

Assessment methods

Method Weight
0%

Study hours

Scheduled activity hours
Assessment written exam 2
Independent study hours
Independent study 148

Teaching staff

Staff member Role
Matthew Shaw Unit coordinator

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