Membrane Role in Microbial Retention

This technical brief explores the role of membranes in microbial retention.

Food and beverage, as well as pharmaceutical industries, rely on microfiltration membranes to remove microbial contamination from liquid or gas streams. This is crucial to prevent product spoilage, foodborne illnesses, and contamination in pharmaceuticals that can lead to severe side effects. Filter manufacturers conduct microbial retention tests to demonstrate the effectiveness of their filters, with sterilizing grade liquid filters exhibiting removal efficiencies of over 99.99999999% of microorganisms challenging the filter.

Food/Beverage Applications:

o Microbiological quality is a common food safety objective achieved through filtration.

o HACCP principles are crucial in reducing the risk of microbial contamination.

Biopharmaceutical Applications:

o Sterile filtration is essential to ensure sterile products in pharmaceuticals.

o Double-layered membrane filters are typically used for critical applications.

Sterile Filtration versus Bioburden Reduction:

o Guidance for microbial removal is provided in FDA documents for sterile drug products.

o Sterilizing grade filters must have a pore size of 0.2 microns or smaller and be validated for removing viable microorganisms.

Cartridge Validation:

o Non-destructive test procedures like bubble point and diffusional flow are used to document the retentive potential of filters.

o Integrity testing of filters is performed to validate retention, especially in biopharmaceutical companies required by the FDA.

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