Prospectus

nl en

Microbial Control in Pharmaceutical Manufacturing

Course
2024-2025

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.

Software
Starting from the 2024/2025 academic year, the Faculty of Science will use the software distribution platform Academic Software. Through this platform, you can access the software needed for specific courses in your studies. For some software, your laptop must meet certain system requirements, which will be specified with the software. It is important to install the software before the start of the course. More information about the laptop requirements can be found on the student website.