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 FLEXBUMIN 5% Biologics License Application 2014. 2. Data on file VV-MED-7407 - FLEX-010 Four Layer Container Composition. 3. Baxalta US Inc. FLEXBUMIN 25%, Albumin (Human), USP, 25% Solution. Package insert. July 2017. 4. Baxalta US Inc. FLEXBUMIN 5%, Albumin (Human), USP, 5% Solution. Package insert. July 2017. 5. Data on file VV-MED-7448 - FLEX-011 Certificate of Non-Use. 6.http://www.baxterbiopharmasolutions.com/sterile-manufacturing-solutions/iv-systems/frozen-premix.html. Accessed September 30, 2017. 7. Data on file VV-MED-7241 - FLEX-007 Latex Free Manufacturing of FLEXBUMIN.