A-A-53667 Thrombin, Usp

Pages 1 - 2 - 3 - 4

A-A-53667A

Material shall remain stable for its labeled shelf life when stored at room temperature 15°-30°C (59°-86°F).

For Type I, non-sterile package containing a vial of Thrombin and vial diluents.

For Type II, sterile package with Tyvek lid containing sterile vial of Thrombin, sterile vial of diluents and sterile transfer device in a sterile inner tray. (SEE NOTE 1).

For Type III, sterile package with Tyvek lid containing sterile vial Thrombin, sterile vial of diluents, sterile transfer device and sterile pump sprayer cap in a sterile inner tray. (SEE NOTE 1).

The diluents supplied shall contain a preservative acceptable to the Bureau of Biologics.

All ingredients entering into the manufacture of the product shall be of a pharmaceutical grade.

Workmanship. The product shall be free from defects which detract from its appearance or impair its serviceability.

Unit. Package (PG).

For Size 1, each package shall consist of vial containing 5,000 units of dried Thrombin, USP, and one vial containing not less than 5 ml of sterile isotonic saline diluents. One package, as specified, constitutes one unit.

For Size 2, each package shall consist of vial containing 20,000 units of dried Thrombin, USP, and one vial containing not less than 20 ml of sterile isotonic saline diluents. One package, as specified, constitutes one unit.

For Size 3, each package shall consist of sterile vial containing 20,000 units of dried Thrombin, USP, and sterile vial containing not less than 20 ml of sterile isotonic saline diluents, one sterile transfer device and one sterile pump sprayer cap. One package, as specified, constitutes one unit.

For Size 4, each package shall consist of sterile vial containing 10,000 units of dried Thrombin, USP, one sterile vial containing not less than 10 ml of sterile isotonic saline diluents, and one sterile transfer device. One package, as specified, constitutes one unit.