Direct flow cartridge filtration for sterile products processing

 

Filtration is a means of sterilising fluids (liquids or gases) through the removal, rather than the destruction or inactivation, of microorganisms. The design, construction and media used in the direct flow filtration of fluids or gases to provide sterile products represents a critical step. Membrane filters for sterile filtration are generally composed of microporous polymeric materials such as polyethersulphone (PES), polyvinylidene fluoride (PVDF), polypropylene, polysulphone and polytetrafluoroethylene (PTFE) each with its own characteristics and suitability for liquid or gas filtration.

 

 

This article looks at the essential requirements for the use of filters for sterile applications.

 

Sandle, T. (2023) Direct flow cartridge filtration for sterile products processing, Pharmig News, Issue 90, pp2-6

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Failure Mode Effects Analysis for Filter Integrity Testing

From a more global point of view, the goal of failure mode effects analysis (FMEA) for filter integrity testing (FIT) is to align the risks as closely as possible with its source. This analysis can identify the root cause of the risk and help the quality assurance staff and operators detect the occurrence of a particular deviation. Additionally, the analysis also helps define the adapted level of training to reduce operator mistakes.

Magnus Stering has written an interesting article for Pharmaceutical Processing about the risk assessment of filter testing.

The article identifies risks for achieving a higher level of FMEA for FIT and for improved quality assurance. It can be accessed here.

Posted by Dr. Tim Sandle

Understanding sterile filtration

An article on filtration of interest, understanding sterile filtration.

The removal of microorganisms from fluids by passage through filters is a complex process, and careful attention must be paid to the selection and validation of the filters, according to Dr Tim Sandle:

"The removal of microorganisms from fluids by passage through filters is a very complex process and is dependent on interactions relating to the chemistry and surface characteristics of the membrane, the micro-organisms, and the suspending fluid. The selection of a membrane filter for a particular product or process is an important choice and one that requires an assessment of the filter, the chemical nature of the product and the physical demands that will be placed on the filter."

Read more at: Cleanroom Technology

The reference is:

Sandle, T. (2012). Making the grade in filters, Cleanroom Technology, December 2012, pp19-20

For more details, see Cleanroom Technology or contact Tim Sandle for a copy

Posted by Tim Sandle