GALAXY®: Both a Production Process and a Container
Shire has developed a manufacturing process and a plastic flexible container system for delivering albumin to our customers.1,2 This drug delivery system, called GALAXY, 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.2 The GALAXY container is a four-layer system,1 which is a proven technology used extensively with pharmaceutical products.3 The GALAXY process is capable of aseptically filling albumin into GALAXY containers,1 which are free of latex, PVC, DEHP, and DEHA.4
*Polyvinylchloride (PVC), diethylhexyl phthalate (DEHP),
diethylhexyl adipate (DEHA)
1. Data on File. Biologics License Application. Baxter Healthcare Corporation. 2. FLEXBUMIN 25% [Albumin (Human)], USP, 25% Solution [package insert]. Westlake Village, CA: Baxter Healthcare Corporation. 3. http://www.baxter.com/about_baxter/scientific_excellence/ctc/medical_plastics.html. Accessed January 16, 2015. 4. Data on File. Certificate of Non-Use: Concerned Chemicals for Environment, 2014. Baxter Healthcare Corporation. 5. http://www.baxterbiopharmasolutions.com/sterile-manufacturing-solutions/iv-systems/frozen-premix.html. Accessed January 20, 2015.