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Microbial Control in Pharmaceutical Manufacturing


Admission requirements

Completed the first year of the master Bio-Pharmaceutical Sciences. Research Project 1 must be completed with at least an average of 7.5 for the components Practical work, Report, and Oral presentation. Only available to students of the Industrial Pharmacy specialization of the master BPS programme.


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 coursedemonstrations 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.


This course is provided by BioTech Training Facility. The specific dates are not available yet.

You will find the timetables for all courses and degree programmes of Leiden University in the tool MyTimetable (login). Any teaching activities that you have sucessfully registered for in MyStudyMap will automatically be displayed in MyTimeTable. Any timetables that you add manually, will be saved and automatically displayed the next time you sign in.

MyTimetable allows you to integrate your timetable with your calendar apps such as Outlook, Google Calendar, Apple Calendar and other calendar apps on your smartphone. Any timetable changes will be automatically synced with your calendar. If you wish, you can also receive an email notification of the change. You can turn notifications on in ‘Settings’ (after login).

For more information, watch the video or go the the 'help-page' in MyTimetable. Please note: Joint Degree students Leiden/Delft have to merge their two different timetables into one. This video explains how to do this.

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 via the provider of the course. Registration via uSis is not necessary.


Coordinator for the Industrial Pharmacy specialization: Emily Ouwehand MA (email:


This course is only available for students of the Industrial Pharmacy specialization.

This information is without prejudice. Alterations can be made for next year.