Sterile Manufacturing
Knowledge
The student
- has knowledge of aseptic production methods and end sterilisation in respect of the production of sterile pharmaceuticals
- have knowledge of the purity requirements which apply to the raw materials and excipients used in the production of sterile pharmaceuticals
Skills
The student
- is able to find, assess and refer to monographs when producing sterile products, and comply with any current storage provisions, as well as other requirements/orders and recommendations
- is able to master isotonicity calculation in accordance with both column I and column II of the pharmacopeia and prepare a worksheet for the production of sterile pharmaceuticals
- is able to practice aseptic working techniques for sterile production on both vertical and horizontal LAF benches.
- is able to practice and reflect on the use of quality assurance systems and possess knowledge of the requirements relating to production hygiene, accuracy and order of production (GMP)
- is able to use their academic knowledge to carry out impact assessments of completed aseptic/sterile production
- is able to master relevant calculations such as new tonicity in connection with the production of sterile pharmaceuticals
- is able to use labelling rules and guidelines - as well as nomenclature
- is able to use sources and referencing techniques for academic writing
General competence
The student
- has insight into the statutes and regulations relating to the supply, labelling and manufacture of pharmaceuticals
- is able to use relevant works of reference and academic literature
- is familiar with innovation processes relating to the production of pharmaceuticals
In addition to the semester fees and course literature, students are expected to provide their own laptops, web cameras and headphones.
Students must obtain their own calculator which is approved for the study programme. Students must have their own shoes that are only used in the laboratory.
Teaching takes place on campus. Some teaching may be done online.
It is required that students themselves become actively involved in their learning process. Individual work accounts for a high percentage of the course workload.
The following learning activities are used during teaching:
Online lessons/lectures
Literature studies and work on theoretical assignments:
Supervision Laboratory exercises with compulsory attendance
During the Sterile Production course, laboratory exercises are very important for ensuring that individual students are able to develop their skills and their ability to reflect on aseptic working techniques/sterile production. In the laboratory, emphasis is placed on hygiene, accuracy, order and control systems. In the event of production, students must be able to master undertaking new tonicity calculations and further impact assessments in respect of the patient and product concerned.
Compulsory attendance (100%) is necessary for ensuring that students achieve the learning outcomes described for the course (skills and general competence).
Attendance yields skills and general competence that cannot be acquired on one’s own.
Compound assessement, grading scale Passed / Not Passed.
All parts described below must be approved/passed in order to receive a final grade in the course.
- Assessment task, comprises 0/100 of the grade, grading scale Approved/ Not approved.
- Compulsory participation - 100%, comprises 0/100 of the grade, grading scale Approved/ Not approved.
- Practical examination, 2,5 hours, comprises 100/100 of the grade, grading scale Passed / Not Passed.
