Karl Küfner GmbH & Co. KG has developed a new type of filter for patient-side filtration of contrast mediums for the use with imaging processes. These applications require a terminal filter that reliably protects patients from contamination while providing a contrast medium flow rate at the same time that is as large as possible. In these cases, the use of virus and bacteria filters is not reliable because the resistance in the filter casing is too great, which can cause the connection between membrane and corpus to burst.
The filter developed by Küfner specifically for this application consists of a plastic-framed metal mesh. The metal mesh used for the filter can be permanently shaped three-dimensionally and, thanks to the plastic frame, it can be individually adapted to components provided by the customer. This combination of materials enables the high flow rate as well as the required stability and material resistance and prevents the forming of bubbles during the injection of the contrast medium. When putting in place the corresponding manufacturing process for metal mesh filters, Küfner took hygiene requirements associated with medical technology standards into account. The company is certified in accordance with DIN EN ISO 13485 and produces the new type of filter (medical device class IIa) in a validated manual process in a class 7 white room.
Metal mesh filters with plastic frames for medical technology applications can generally be used for all applications during which a liquid or gas is introduced into the patient and a terminal filter must reliably prevent contamination. When developing a suitable filter, Küfner can respond to the particularities of the medical use, such as the flow behaviour, and coordinate the selection of materials for the plastic and the mesh to meet individual requirements. For the first time, Küfner is able to carry out the manual production of filters in small and medium lot sizes under the same hygienic conditions as parts manufactured in large batches.
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