Microbiological quality assurance of the environment

Duration

10h Th, 15h Pr

Number of credits

Lecturer

Sébastien Bontems

Language(s) of instruction

French language

Organisation and examination

Teaching in the second semester

Schedule

Schedule online

Units courses prerequisite and corequisite

Prerequisite or corequisite units are presented within each program

Learning unit contents

Contents





The teaching includes several parts relating to the microbiological quality of the environment, pharmaceutical or similar products and agro-food products in particular. 
 The impact of certain microbial contaminations in the environment (industrial and recreational water), of para- and pharmaceutical products or food consumption reported in the literature is described: infectious risk, degradation of products and alteration of bacteriological analysis results.
 This course introduces the student to production in compliance with GMP/GLP and microbiological quality assurance. The control techniques in a production flow are presented: principles of microbiological control techniques of raw materials, finished products and the production environment.
 The identification of health risks related to natural and artificial bathing waters will also be discussed. An overview of the legislation in force will be given, as well as the means of control used to ensure compliance with it.
 A reminder of basic microbiological techniques and some pathogens of interest will be presented.
 Subsequently, the aspects of a quality assurance system in a microbiology laboratory are presented with emphasis on the specific aspects. The elements of internal quality control in microbiology are explained and illustrated.  The course also describes the questions presiding over the choice of new techniques to be implemented in a laboratory, the objectives of screening, diagnostic and confirmatory tests, the elements to be verified or included in a validation file of tests used in microbiology.
 Finally, the main biosafety aspects associated with the handling of infectious agents are presented.

Table of contents:
-Introduction -Epidemics related to environmental quality problems -Controlling microbiological environmental quality -Problems related to environmental quality -Challenges faced in industry - production units -The problem of recreational water quality - microbiological risks & controls -Contaminating microorganisms and their modes of transmission -Definition of appropriate standards: pharmacopoeias and norms -GMP and QA, controls during production  -Review of basic microbiological techniques -Quality assurance in microbiology laboratories -Standards: ISO 15189 -Quality system, specificities in microbiology -Premises and environment - Equipment -Calibration and reference materials -Sample processing -Reports -Biosafety rules.

Learning outcomes of the learning unit

This course provides an overview of various considerations related to microbiological quality assurance of the environment, pharmaceuticals and foodstuffs and the specific elements of a quality system in a microbiology laboratory.
At the end of the course, the student will be aware of the risks of abnormally high contamination or contamination by unwanted microorganisms and the consequences. They should be able to
 
 
-Describe the consequences of product contamination: product degradation and infectious risk to the consumer or exposed population. -Describe the consequences of contamination in recreational waters: health risks and means of control. -Describe the characteristics and sources of the most common contaminants. -Summarise the basic notions of production under Good Manufacturing Practice (GMP), analysis under Good Laboratory Practice (GLP) and methods of assessing microbiological quality. -Establish, argue and justify a microbiological control plan for a production stream or bathing water and select appropriate tests to verify the microbiological quality of products. -Propose strategies to reduce the level of contamination of raw materials above acceptable levels -Propose strategies to reduce the level of contamination of bathing waters -Establish plans for monitoring a particular environment and carry out tests for the detection and identification of contaminants. -Formulate architectural and space planning recommendations to reduce the risk of airborne contamination. -Establish plans for the validation and verification of new techniques, reagents and equipment in a microbiology laboratory -Make recommendations concerning biosafety with regard to operators and the environment. 
 

 

Prerequisite knowledge and skills

Prerequisite or corequisite units are presented within each program.

Planned learning activities and teaching methods

The course is taught as lectures, supported by PowerPoint-type slides.
Students are invited to ask their questions during lectures, after or by email.
The practical work aims to put the student in a real life-like situation. He is asked to audit microbiological related aspects of a sector of the clinical microbiology lab of the university hospital. He visits the sector, interviews the lab technicians or any operator on the activities.  He has to estimate the microbiological risks either for the operator or the results of the performed analysis.  He proposes a control plan and performs the microbiological controls of the environment. He reads the cultures and prepare an extensive report from the analysis of the situation up to the interpretation of results; possibly suggests corrective actions.
 

Mode of delivery (face to face, distance learning, hybrid learning)

Face to face and practical training

Recommended or required readings

Print of set of slides are distributed before starting lectures or are posted on the ULg website and can be downloaded by the students.
Reference books that could help for better understanding or for extensive learning:
- Microbial Quality Assurance in Pharmaceuticals, Cosmetics, and Toiletries, R. Baird,  Sally F. Bloomfield, Taylor and Francis, 1996
- Cumitech 31A, 2009, Verification and Validation of Procedures in the Clinical Microbiology Laboratory, ASM press
- Cumitech 39, 2003, Competency Assessment in the Clinical Microbiology Laboratory, ASM press
- Bactériologie médicale, F.Denis, MC. Ploy, C. Martin, E. Bingen, R. Quentin et al. 2ème Ed., 2011, Masson Paris
- Biological Safety, principles and practices. D. Fleming & D. Hunt 2006, ASM Press
- Principle and Practice of Desinfection, Preservation & Sterilization, Russel, Hugo & Ayliffe, 2012, Willey-Blackwell

Any session :

- In-person

oral exam

- Remote

oral exam

- If evaluation in "hybrid"

preferred in-person


Additional information:

The global assessment includes
- an oral exam with a written preparation
- and the mark of the practical work report

Work placement(s)

Internship opportunity during last year of master (final thesis)

Organisational remarks and main changes to the course

The practical work aims to put the student in a real life-like situation.
They are organized within the clinical microbiology lab of the university hospital of Liege

Contacts

Clinical Microbiology Department
University Hospital of Liège,
B-23 Sart Tilman,
4000 LIEGE
Belgium

Secretary
For any contact or appointment request, please address your demand to the secretary Mrs Stephanie Wauquier

• Phone : 00.32.4.323.22.90
• Telecopy: 00.32.4.323.24.40
• email : micromed@uliege.be

Association of one or more MOOCs

Items online