Clean Rooms and Proper Practices for Modern Pharmaceutical Preparations

Garant předmětu:

Martin Mayer

Lecturer:

Tutor:

Supervisor:

Department of Biomedical Technology

Synopsis:

Students will gain expert insight into the functioning of superclean spaces, isolators, and the basics of gas dynamics. Students will also become familiar with the requirements of clinical evaluations for medicinal products of modern therapy, with the design and division of superclean spaces for the production of these products; they will learn about the theoretical foundations and necessary components of quality assurance systems and, using the example of Good Manufacturing Practice (a system common in pharmacy), they will gain insight into the activity of production and control pharmaceutical operations of modern companies developing medicinal products for modern therapies. They will learn about the necessary legislation, requirements for validation and qualification of instruments, they will acquire the basics of metrology. In the theoretical part, students will be introduced to the latest technologies of cell and gene therapy, which are tested in clinical evaluations. In the practical part, students will try the production steps for cell preparations in super clean rooms.

Requirements:

Form of verification of study results: Successful completion of the final verification of knowledge from the Good Manufacturing Practice system discussed within the course. The awarding of the exam will have a written and an oral part. The written part will be done in the form of a test, the number of questions is 15 to 30. Some questions may have more weight in the assessment than others, for example those that are more complex and complex. The evaluation will correspond to the percentage of success exactly according to the valid ECTS classification scale. If the results of the written part are sufficient for classification, the oral part may be waived.

Student requirements: 100% participation in exercises, practical skills of aseptic handling of medicinal products: material handling, work in an isolator, sanitation and cleaning, dressing; implementation of prepared laboratory tasks.

Syllabus of lectures:

1. Quality systems and Good practice, documentation, quality.

2. Clean rooms and ventilation, basics of gas mechanics, gas quality, pressure differentials.

3. Basics of laboratory techniques and their implementation in a quality system environment.

4. Basics of work in clean areas, hygiene, dressing.

5. Production, quality control, certification. GMOs, modern and gene immunotherapy preparations, their production and quality control.

6. Risk analysis and management. Devices and their use, biomedical engineering in production.

7. Preparations of modern therapy, human tissues and cells, cryostorage, biobanking.

8. Immunodiagnostics, modern analytical and detection methods in hematology.

9. Monitoring – microbiology, air quality, temperatures, pressures, control systems.

10. Closed and open technologies, clean rooms, operating theaters and isolators, Basics of metrology, validation, qualification, Technological transfer of production, clinical evaluation, regulatory environment, ethics.

Syllabus of tutorials:

1. Safety of work in the laboratory, basics of aseptic production arrangement, pressure cascade.

2. Dressing in clean spaces, hygiene, sanitation. Work with material in clean areas, interleaving passes.

3. Laminar boxes, isolators, work safety in BSL classes.

4. Basic manufacturing steps for cell preparations in super clean rooms. Handling of cell cultures.

5. Sampling from cell cultures.

Study Objective:

Study materials:

Note:

Further information:

No time-table has been prepared for this course

The course is a part of the following study plans:

• Biomedical Laboratory Methods (compulsory elective course)