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Studiegids

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Microbial Control in Pharmaceutical Manufacturing

Vak
2021-2022

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.

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 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.

Timetable

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

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

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

Contact

Coordinator for the Industrial Pharmacy specialization: Emily Ouwehand MA (email: studyadvisorBPS@lacdr.leidenuniv.nl).

Remarks

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

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