INTERCEPT Blood System for Plasma
Product Description
The INTERCEPT Blood System for plasma is a Class III medical device that is intended for the ex vivo preparation and storage of pathogen inactivated plasma intended for transfusion. The INTERCEPT Blood System for plasma is used to inactivate bacteria, viruses, parasites, and leukocytes. This process for treatment of plasma products is intended to reduce the risk of transfusion-associated transmission of viruses, bacteria, and parasites, and may also reduce the risk of adverse effects due to transfusion of contaminating donor leukocytes. The device uses amotosalen HCl (a photoactive compound) and long-wavelength ultraviolet (UVA) illumination to photochemically treat plasma.
The INTERCEPT Blood System for plasma is a sterile, non-pyrogenic fluid path integrated disposable plastic processing set. The set consists of 15 mL of amotosalen solution in a plastic container, a plastic illumination container, a compound adsorption device, and three plastic storage containers, all sequentially integrated. The single-use set is manufactured from inert polyolefin PL 2411, PL 2410 and PL 269 plastics compatible with plasma.
Plasma collected by apheresis or prepared from whole blood (containing <4 x 106 RBC/mL) is connected to the processing set using a sterile-connect device. Plasma to be treated is in a volume range of 385 mL to 650 mL, including anticoagulant and prior to addition of amotosalen. Plasma flows through the amotosalen container and into the illumination container. Prior to illumination the nominal concentration of amotosalen in plasma is 150 µM. Illumination is provided by the INTERCEPT Illuminator. This ancillary Class I device is microprocessor controlled and is designed to deliver a target UVA treatment of 3 Joules/cm2.
The INTERCEPT Plasma processing set includes a compound adsorption device (CAD), which significantly reduces the level of residual amotosalen in plasma prior to storage. The CAD consists of ground adsorbent beads and an ultra-high molecular weight polyethelene binder. The illuminated plasma flows by gravity through the CAD and into the storage containers. INTERCEPT Plasma is stored according to requirements for frozen plasma until released for transfusion.
Amotosalen Hydrochloride
Amotosalen HCl is a synthetic psoralen compound that reversibly intercalates
into the helical regions of DNA and RNA. Upon illumination with UVA
light at 320 to 400 nm, amotosalen forms covalent bonds with pyrimidine
bases in nucleic acids. The genomes of pathogens and leukocytes cross-linked
in this manner can no longer function or replicate. No pharmacological
effect of residual amotosalen is intended.
Technical Data Sheets section page 1 of 7 
Use of the INTERCEPT Blood System in the United States is limited by Federal law to investigational use. If you are a resident of the U.S., please click here.
The information on this site is not country-specific, and may contain information that is outside the approved indications for the country in which you are located. The INTERCEPT Blood System is CE marked for use with platelets and plasma.
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