Entry requirements

60 credits including 45 credits in chemistry/chemical engineering/pharmaceutics/biotechnology and 15 credits in cell biology/microbiology.Filtration in Biopharmaceutical Industry I. Proficiency in English equivalent to the Swedish upper secondary course English 6.

Learning outcomes

After the completion of the course, participants will be able to:

• discuss criteria for filter selection, including filter type, configuration, and stress resistance,
• select appropriate methods for sterilizing grade filter characterization and integrity testing,
• analyze bacterial breakthrough risk factors and mitigation strategies during sterile filtration.

Content

The course covers both theoretical and practical basis of sterile filtration of biopharmaceuticals.

The following topics will be covered:

Historical overview of sterile filtration development from a regulatory perspective. Sterile filtration fundamentals. Sterilizing grade filter selection and characterisation. Sterilizing grade filter use, handling and design considerations. Filtration of diminutive bacteria. Mycoplasma filtration. Sterilizing grade filter integrity testing. Sterilization of sterilizing grade filters.

Instruction

Lectures, seminars, and laboratory praxis. 

Assessment

Mandatory active participation in laboratory praxis and seminars (1 credit). Oral examination (2 credits).