WATERS IGL COLD STORAGE SOLUTION

WATERS IGL COLD STORAGE SOLUTION (CSS) is a Solution for Hypothermic Flushing and Storage of Kidney, Liver and Pancreas Organs

Same composition as the solution originally formulated by F.O.
Belzer, MD and James Southard, PhD, at the University of Wisconsin

Available in 1 and 2 Liter bags, labeled with 2-year shelf life, to be
stored between 2° – 25°C (35.6° – 77°F)

Ready to use (no filtration)

Manufactured according to cGMP, by an ISO 13485 and ISO 9001
certified company.

CSS is a clear to light yellow, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs. The solution has an approximate calculated osmolarity of 320 mOsm, a sodium concentration of 29 mEq/l, a potassium concentration of 125 mEq/l, and a pH of approximately 7.4 at 20°C.

CSS must be cooled to 2° to 6°C (36° to 43°F) prior to use. The cold solution is used to flush the isolated organ immediately before removal from the donor and/or immediately after removal from the donor. The solution is then left in the organ vasculature during hypothermic storage and transportation. CSS is to be used for cold storage of the organ and is not acceptable for  ontinuous machine perfusion. Administration of CSS, at the recommended temperature, will effectively cool the organ and lower its metabolic requirements.

Constituents & Amount/1000 mL
Hydroxyethyl Starch (HES) 50.0 g
Lactobionic Acid (as Lactone) 35.83 g
Potassium Phosphate monobasic 3.4 g
Magnesium Sulfate heptahydrate 1.23 g
Raffinose Pentahydrate 17.83 g
Adenosine 1.34 g
Allopurinol 0.136 g
Glutathione (reduced form) 0.922 g
Potassium Hydroxide 5.61 g
Sodium Hydroxide/Hydrochloric Acid Adjust to pH 7.4
Sterile Water for Injection (SWI) To 1000 mL Volume