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What is the fiber-free release standard of the microporous filter membrane, and how to prevent the f

Issuing time:2023-08-18 14:47

What is the "fiber-free release" standard of microporous filtration membrane? It refers to the phenomenon of fiber shedding on the surface of the membrane caused by factors such as material, production process, and chemical compatibility during the filtration process. So far, Microporous membranes do not yet have a specific, universally accepted standard for "no fiber release", and for the medical industry, "no fiber release" generally means that the filter should not release fibers into the filtrate during filtration, including Industries such as food and beverage and semiconductor manufacturing are also of particular importance, where the purity of the filtrate is critical. However, there are many standards and regulations in different countries and industries, which implicitly or explicitly require the filter (membrane) not to release fibers or particles into the filtrate, such as in the US Food and Drug Administration (FDA ) and the European Medicines Agency (EMA ) and other regulatory agency guidelines require that pharmaceutical products be free of particle contamination, including the fibers in filters.

PES filter membrane for biopharmaceutical manufacturing.jpg

In the process of membrane filtration, there are several reasons for the factors affecting fiber shedding.

1. The quality (material) of the filter membrane

Different materials have different amounts of fiber shedding. Good materials have obvious advantages. In addition, the dense layer on the surface of the membrane will play a key role in fiber shedding during the membrane manufacturing process. With the current production process, including optimizing the casting process and using Appropriate additives or binders, some membrane materials such as mixed cellulose acetate membranes, nylon membranes, polypropylene membranes, etc., can meet the standard of no fiber release, most of the modern use of high-quality filter membrane materials designed and manufactured, Such as filter membranes made of materials that are inherently less likely to shed fibers, such as polyethersulfone (PES), PES membranes used in biopharmaceutical manufacturing, or materials such as polyvinylidene fluoride (PVDF).

2. During the manufacturing and post-processing, the manufacturing and post-processing of filter membranes and filters should minimize fiber release, which involves methods such as post-manufacturing cleaning, backflushing, reagent removal, air pressure cleaning, etc., to loosen filter membranes and filters Fiber and other steps.

PES membrane filter for sterile filtration in healthcare.jpg

3. For correct use, the filter membrane should be used correctly according to the manufacturer's guidelines, which includes not exceeding the recommended flow rate or pressure, and hydrophilic wetting of the filter membrane before use, etc.

4. Periodically test the filtrate for particle contamination, including fibers, by visual inspection, light-obscuring particle counting, or other methods, depending on the requirements of the industry.

PES medical filter membrane for pharmaceutical applications.jpg

Membranes are manufactured to minimize fiber shedding, but it is still recommended that proper handling, installation and cleaning procedures be followed in practice to maintain membrane integrity and minimize the risk of contamination, always refer to the manufacturer’s guidelines for use Membrane Guidelines and Recommendations. Fiber-free release criteria for filter membranes should always refer to the specific regulations and standards applicable in your industry and country to ensure full compliance with all requirements related to fiber release.

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