Admission requirements
Only for students of the specialisation Industrial Pharmacy.
Description
The changed pharmaceutical environment from primarily oral administration forms to more-and-more injection-based preparations requires that Qualified Persons also have knowledge of how sterile dosage forms are produced as well as of the critical quality attributes involved. Personal experience with sterile work in practice in cleanrooms is therefore an essential part of the training, including practical experience with dressing procedures, cleaning procedures, environmental monitoring and media fills. Moreover, during this course demonstrations are provided of various types of sterile preparations.
This course aims to:
Provide a practical training in how to work in a cleanroom.
Increase knowledge on contamination control mechanisms in the production of sterile products.
Course objectives
At the end of this course the student is able to:
Adhere to guidelines and procedures for working in cleanrooms.
Describe and explain contamination control mechanisms in the production of sterile products.
Timetable
This course is offered by Biotech Facility Training and is scheduled in semester 1, period 2.
Mode of instruction
Lectures, tutorials, practical work.
Assessment method
This course will be concluded by a pass/no pass based on participation in all components of the course. Students must provide a certificate for the result to be registered in uSis.
Reading list
Will be announced during the course.
Registration
Enrollment via MyStudymap is not necessary for this course. Students need to enroll via the website of PCS (contact the coordinator of the specialisation for questions).
Contact
Coordinator of the Industrial Pharmacy specialisation: t.b.d.
Remarks
This course is only available to students of the Industrial Pharmacy specialisation.
This information is without prejudice. Alterations can be made for next year.