The Fixation Rig provides the environment for the fixation process of fresh porcine aortic root tissue valves.
The fixation process is performed in order to fix or cross-link the collagen in the tissue in order to prevent an immunologic response in-vivo.
The process is also intended to maintain, as close as possible, the geometry of the porcine valve.
The fixation processes consists of two steps.
The initial step that dictates the shape of the valve utilizes a fixation rig to subject the tissue to a 0.2% glutaraldehyde solution (the cross-linking agent) at a set time and pressure.
The second step consists of continuation of the cross-linking under ambient conditions outside of the fixation rig in 0.2% glutaraldehyde solution to allow completion of the cross-linking process. The equipment being qualified as part of this IQ is for the 1st step of the fixation process.
The Fixation Rig system consists of a sink that can accept 14 fixtures (known as piccolo tubes) used to hold the valves immersed in the solution. Each piccolo tube accepts 8 valves for a total of 112 valves per fixation rig. Each sink is capable of operating individually and fixes tissue for the product lines: Root Pressure and Hancock II (HKII). Root Pressure tissue utilizes a 0.2% glutaraldehyde solution known as Buffered Isotonic Glutaraldehyde or BIG. Hancock II tissue utilizes a 0.2% glutaraldehyde solution known as “Glutaraldehyde, 0.2%” or GA5. The rig maintains a water column height in a standpipe in order to subject the valves to the correct pressure (known as head pressure).
Included with the system are 8 fix rig sinks.
Each one is one fixation machine consist of water piping and other exhaust system for whole system.
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