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EXPORT-ORIENTED MANAGEMENT - IMC Fachhochschule Krems

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Teaching Concept<br />

Students are assisted during their application process and develop strategies for their<br />

application.<br />

Evaluation<br />

Updated CVs and motivation letters<br />

Scale up – Scale down techniques<br />

Semester Hours per week Subject code ECTS<br />

Fall 2 SCALE 2<br />

Learning Outcomes/ Course Objectives<br />

The students learn the most important purification techniques commonly used in<br />

biotechnological industry with a special emphasis on their scalability.<br />

Prerequisites/ Level<br />

Advanced<br />

Course Description<br />

The four main downstream operations are outlined: Separation, Isolation of the product.<br />

Purification, preparation in pure state. Thus the following unit operations are examined:<br />

filtration, lysis, flocculation, sedimentation, extraction, chromatography, adsorption,<br />

precipitation, crystallisation, drying and centrifugation. Purification strategies of specific<br />

products are discussed to high lighten the advantages and disadvantages of these<br />

processes.<br />

Teaching Methods<br />

Lecture<br />

Evaluation<br />

Final exam<br />

Standardization<br />

Semester Hours per week Subject code ECTS<br />

Fall 1 SCT 1<br />

Learning Outcomes/ Course Objectives<br />

General overview how and which standards (engineering as well as pharmaceutical) are<br />

applied in the pharmaceutical industry.<br />

Prerequisites/ Level<br />

Advanced<br />

Course description<br />

The course covers the basic principles how engineering and especially pharmaceutical<br />

standards are implemented respectively transcribed into internal specifications (e.g. URS,<br />

Material Specification, Product Specification) and the concerned parts of the CTD of<br />

regulatory submissions. Students will be introduced to national (e.g. ÖNORM, DIN) and<br />

international (e.g. EN, ISO, Ph.Eur.) standards and regulations (e.g. DGVO, MSV, AM-VO).<br />

FHR-5-0008_Vers.03_Rev.00_2012 549

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