T. GEETHA, Ph. D.
¾ Types of Aseptic filtration
¾ Types of materials used for aseptic filters
¾ Validation of filters
What is filtration?
The process of removing particulate matter from the solution
by passing it through a porous medium
What is Sterilization?
Sterile - Free from any living organisms
Sterilization - Process of killing or removing microorganisms
(including pathogenic and other bacteria, vegetative forms and
spores) from a product to ensure that it is sterile
What is Aseptic Filtration (Sterile Filtration)?
Aseptic filtration: Physical removal of microorganisms by size
exclusion/adsorption on the sterile filter medium (I.e.,
membranes of pore size 0.22μm or less)
¾ Many liquid pharmaceutical and biological products cannot
withstand any form of thermal sterilization
¾ Aseptic filtration involves passing the solution through a
sterile 0.1 to 0.22 μm membrane filter and capturing the
filtrate in a pre-sterilized bulk container
Positive pressure systems are advantageous over
negative pressure systems as:
• Greater pressure can be applied
• The need for transfer of sterile material from the
vacuum flask to point of use is eliminated
• The possibility of leaks drawing contamination into the
flask is eliminated
1. The sterilization of the filter and downstream
tubing, equipment etc.
2. The filtration of the fluid
3. The aseptic management of the sterilized liquid
Aseptic Filtration process involves three basic steps
¾ Reverse Osmosis
Types of Aseptic Membrane Filtration
Ranges of Filtration Process
$ Pore size of the filter is around 0.1-10 μm
$ Remove bacteria, Giardia cysts and Cryptosporidium
$ Neither microfiltration nor ultrafiltration can remove
$ The pore size of filter is around 0.01 – 0.1 μm
$ Ultrafiltration utilizes pressures up to 145 psi (10 bar)