Package Challenge/Distribution Testing Procedure Clause Samples

Package Challenge/Distribution Testing Procedure. Prior to use, GraftJacketTM must be rehydrated. At least 200 ml of rehydration fluid (sterile normal saline or sterile lactated Ringer’s solution) must be used. GraftJacketTM, with backing, must be submerged for at least five minutes in a dish of 100 ml of rehydration fluid. After five minutes the backing must be removed, and the product submerged for an additional five minutes in a separate dish of 100 ml of rehydration fluid. When fully rehydrated, the product is soft and pliable throughout.