3 ECTS credits
90 h study time
Offer 1 with catalog number 4023439ENR for all students in the 2nd semester at a (E) Master - advanced level.
In this course, students will learn how to reach, guard and preserve the sterility of medicines and other pharmaceutical preparations.
Students will also learn about cleanrooms and biosafety management of medical production facilities and about specific sterility measures for cell, gene and tissue therapy products. Furthermore, the students will get insight in the production process of solid dosage forms. Special attention is paid to the excipients, the quality, the production techniques and parameters as well as the release, biological availability and stability of the active substances in solid dosage forms.
The course covers the following topics:
- Sterility in the pharmacy and general sterilization processes (heat sterilization & filtration)
- Pyrogens and endotoxins
- Microbicide and microbistatic agents
- Preservation of medicines and cosmetics
- Parenteralia and biofarmaceuticals
- Industrial sterilisation processes
- Cleanrooms & Biosafety
- Sterility Assurance
- Special Sterility measures regarding cell, gene and tissue therapy products
- Agglomeration and (coated) tablets
- Controlled release from solid dosage forms
The topics about sterility of medicines and their sterilization processes are covered by Prof. J. De Kock.
The topics about solid dosage forms are covered by Prof. C. Vervaet.
The student:
- knows what is understood by ‘sterility’ and how this needs to be applied for the preparation of sterile medicines in the pharmacy
- can explain to a third person which sterilisation methods are being used in the pharmacy and how they work
- can identify and correct the consequences of bad sterilisation practices
- understands and is able to explain how disinfection solutions work, knows which factors influence their disinfection efficacy and how they can cause resistance
- understands the concept of ‘self-sterilisation’ in the context of preservatives and is able to explain it to a third person
- knows the legislation concerning the enforced or prohibited use of preservatives in sterile preparations
- knows the sterility criteria of parenteral medicines and biopharmaceuticals and knows how these criteria (sterility, pH, osmolarity) are influenced by the route of application
- can critically explain the difference between the quality criteria of parenterally applied chemical substances and biopharmaceuticals in the context of the latter’s biological origin
- knows and can explain to a third person which sterilisation techniques are used in the industry and how
- knows the differences between cleanroom and biosafety management and can explain this to a third person
- Has sufficient knowledge about which factors have an impact on the sterility of pharmaceuticals, how to test this, which process monitoring techniques can be applied, what bioburden is and which barrier systems can be installed to prevent microbiological contaminations
- can critically evaluate which special attention needs to be paid to the sterility of cell, gene and tissue therapy products
- knows the functions of the excipients in solid dosage forms
- knows the techniques used to manufacture solid dosage forms
- can assess the impact of the composition and the production parameters on the drug release rate of solid dosage forms
- has knowledge about the factors that determine the release, bioavailability and stability of the drug in a solid dosage form
- has knowledge about the interaction between the composition, production and quality of solid dosage forms
The final grade is composed based on the following categories:
Written Exam determines 100% of the final mark.
Within the Written Exam category, the following assignments need to be completed:
Written exam. Final score on /20.
This offer is part of the following study plans:
Master of Drug Development: Pharmacist (only offered in Dutch)
Master of Drug Development: AR without officinastage (only offered in Dutch)