Study Guide

Objective

The participants are able to
- outline the main principles needed in the planning of a bioprocess
- demonstrate good clean room practices and to design and implement the most important activities in cleanrooms
- describe quality systems, regulation and sustainable development and their role in biotechnlogical production.

Content

- Planning of biotechnological production and cleanrooms
- Quality systems and production control and management systems

Materials

Whyte, William. Cleanroom Technology - Fundamentals of Design, Testing and Operation

Teaching methods

Lectures, group work, individual tasks, lab demomstrations

Content scheduling

- Planning of biotechnological production and cleanrooms
- Quality systems and production control and management systems

Autumn 2024

Further information

ITS

Evaluation scale

H-5

Assessment methods and criteria

Tasks 50 % (8 * 2 p = max 16 p)
Grading of tasks: 0-2 p.
Exam 50 % (max 16 p)

Course grading:
16 p = 1
19 p = 2
22 p = 3
25 p = 4
28 p = 5

Assessment criteria, fail (0)

16 p = 1
19 p = 2
22 p = 3
25 p = 4
28 p = 5

Assessment criteria, satisfactory (1-2)

16 p = 1
19 p = 2
22 p = 3
25 p = 4
28 p = 5

Assessment criteria, good (3-4)

16 p = 1
19 p = 2
22 p = 3
25 p = 4
28 p = 5

Assessment criteria, excellent (5)

16 p = 1
19 p = 2
22 p = 3
25 p = 4
28 p = 5

Objective

The participants are able to
- outline the main principles needed in the planning of a bioprocess
- demonstrate good clean room practices and to design and implement the most important activities in cleanrooms
- describe quality systems, regulation and sustainable development and their role in biotechnlogical production.

Content

- Planning of biotechnological production and cleanrooms
- Quality systems and production control and management systems

Evaluation scale

H-5