Microbiological quality assurance of the environment

Duration

10h Th, 15h Pr

Number of credits

Lecturer

Pierrette Melin

Language(s) of instruction

French language

Organisation and examination

Teaching in the first semester, review in January

Schedule

Schedule online

Units courses prerequisite and corequisite

Prerequisite or corequisite units are presented within each program

Learning unit contents

Contents

• Introduction
• Identifications of hazards associated with microbiological contaminations
• Description of contaminating microorganisms, reservoirs and transmission
• Contaminations: risks, causes and outcomes
• Control of microbiological contamination during manufacture  
• GMP and QA
• Systems of reference, official and unofficial limits
• Development of preservative systems
• Microbiological methods
• Rules of Biosecurity
• Microbiological controls
• Internal quality control in microbiology
• Aims and criteria for screening, diagnostic and confirmation tests
• Verification and validation

Learning outcomes of the learning unit

At the end of this course, students will be able to:

• describe risks of microbiological contamination along a manufacturing process
• describe the main contaminating microorganisms, reservoirs and transmission.
• describe the varied hazards associated with microbiological contamination of pharmaceutical products, of cosmetics and toiletries, of food products or on results in a microbiology lab.
• apply and integrate the concepts in GMP, GLP and QA.
• refer to systems of reference, official and unofficial limits.
• implement and manage a internal quality control system in a microbiology lab
• propose and perform the validation and verification of new methods, new reagents or new equipment in a microbiology lab.
• propose recommendations for biosecurity related to operators and 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)

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

Assessment methods and criteria

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

Work placement(s)

Internship opportunity during last year of master (final thesis)

Organizational remarks

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 MC Lhôte

• Phone : 00.32.4.366.24.39
• Telecopy: 00.32.4.366.24.40
• email : micromed@uliege.be