GALAXY®: Both a Production Process and a Container
GALAXY is a manufacturing process and a plastic flexible container system for delivering albumin to our customers.1,3,4 This drug delivery system enables the manufacturing of pharmaceutical agents that cannot be terminally sterilized because they are heat sensitive.1
FLEXBUMIN® 25% is available in 50 mL and 100 mL GALAXY plastic containers. FLEXBUMIN 5% is available in 250mL GALAXY plastic containers.3,4 The GALAXY container is a four-layer system,2 which is a proven technology used extensively with pharmaceutical products.5 The GALAXY process is capable of aseptically filling albumin into GALAXY containers,1 which are free of latex, PVC, DEHP, and DEHA.*5,6,7
*Polyvinylchloride (PVC), diethylhexyl phthalate (DEHP),
diethylhexyl adipate (DEHA)
1. Data on file, VV-MED-7536, Shire Inc. 2. Data on file, VV-MED-7407, Shire Inc. 3. Baxalta US Inc. FLEXBUMIN 25%, Albumin (Human), USP, 25% Solution. Package insert. 4. Baxalta US Inc. FLEXBUMIN 5%, Albumin (Human), USP, 5% Solution. Package insert. 5. Data on file, VV-MED-7448, Shire Inc. 6.http://www.baxterbiopharmasolutions.com/sterile-manufacturing-solutions/iv-systems/frozen-premix.html. Accessed January 23, 2019. 7. Data on file, VV-MED-7241, Shire Inc.