Process and apparatus for removal of unwanted fluids from proces

Liquid purification or separation – Processes – Separating

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55421, 210188, 2101951, 210252, 210254, 2102571, 210295, 210435, 210436, 210472, 210767, 604406, 604410, B01D 3700, B01D 3600

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056017308

DESCRIPTION:

BRIEF SUMMARY
This application is an application filed under 35 U.S.C. 371 of PCT/GB93/01849 filed Sep. 1, 1993.
The invention relates to the removal of unwanted fluids from processed blood products.
As used herein, "blood product" refers to any treated or untreated fluid associated with living organisms, particularly blood, including whole blood, warm or cold blood, and stored or fresh blood; treated blood, such as blood diluted with a physiological solution, including but not limited to saline, nutrient, and/or anticoagulant solutions; one or more blood components, such as platelet concentrate (PC), platelet-rich plasma (PRP), platelet-free plasma, platelet-poor plasma, plasma, packed red cells (PRC), or buffy coat; analogous blood products derived from blood or a blood component or derived from bone marrow. The blood product may include leucocytes, or may be treated to remove leucocytes. As used herein, blood product refers to the components described above, and to similar blood products obtained by other means and with similar properties.
When a blood product is processed by a functional biological device there is a clinical risk of gases, including air, remaining in the processed blood product.
The sources of residual oases include the functional biological device performing the process and tubing used for passing the blood product to and from the device. There may also be gases present in the container to which the processed blood product is transferred.
The term "functional biomedical device", as used herein, may be any of a number of devices or assemblies in which air or gases are present and/or may collect or form, or should be displaced prior to use of the assembly. Exemplary functional biomedical devices include a filter, such as a leucocyte depletion filter; a separatory device, such as a platelet concentrator, preferably a non-centrifugal platelet concentrator; a debubbler; or a pump. The functional biomedical device may also include a device for destroying biological contaminants, such as a high intensity light wave chamber, or a device for sampling a biological liquid. Exemplary devices for use with red blood cells are disclosed in U.S. Pat. Nos. 4,925,572 and 4,923,620; an exemplary device for use with platelets is disclosed in U.S. Pat. No. 4,880,548. It is intended that the invention should not be limited by the type of functional biomedical device employed in a specific assembly.
The presence of such residual gases can reduce the quality of the biological fluid being stored and thus can reduce the time period for which the biological fluid can be stored. In addition, such gases reduce the storage capacity of the containers in which the blood product is held. In addition, such residual gases, on transfusion, may enter the recipient of the transfusion and result in embolism. The clinical consequences of this are well documented in the literature.
It is thus important to have as little gas as possible, ideally no gases, left in the processed blood product. Section IV 2.2.2.1 of the European Pharmocopoeia states that less than 5 ml of gases should remain in the container for processed blood product.
It is also important that any processing be wholly free from bacterial contamination from the environment.
It has previously been proposed to provide in the functional biomedical device, an outlet for the bleeding off of air collecting in the device. The vent may include a hydrophobic filter medium--see for example GB-A-1585989 which separates air from a filtered blood product. It is a problem with such a proposal that this deals only with air at or reaching the functional biomedical device. It does not remove air exiting the functional biomedical device with the processed blood product.
In another proposal, a by-pass line is provided between a first container for the unprocessed blood product (often called the "donor bag") and a second container receiving the processed blood product (often called the "transfer bag"). The by-pass line by-passes the functional biomedical device and includes a clamp or breakaway

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