Flexing a New Package
Baxter is using its Galaxy aseptic process to fill and seal flexible packages for its new Buminate product.
Baxter Healthcare Corp. is now launching a human albumin product in a single-dose flexible package. FDA approved Flexbumin 25% solution in October 2005. The firm’s Buminate human albumin 25% solution has been available in glass packaging for more than 50 years.
Flexbumin has the same indications and the same stability as Buminate, says Donna Williams, vice president, marketing, for Baxter’s BioPharma Solutions division. Flexbumin can be stored for up to two years at room temperature. “The advantages of flexible plastic packaging outweigh those of a glass container,” she says. These include less risk of breakage, lighter weight, and less space required for storage.
The ready-to-use solution should help reduce mixing mistakes, says Williams. “JCAHO’s [Joint Commission on Accreditation of Healthcare Organizations] medication management standards raised the bar for high-risk preparations in order to avoid mistakes,” she says. “Premixed containers are recommended for enhanced safety.”
Flexbumin is produced using Baxter’s Galaxy aseptic process for heat-sensitive products, which the firm has employed for more than 16 years for packaging chemicals and small molecules. Many of them are shipped frozen, whereas Flexbumin is at room temperature. Using barrier isolation technology, Baxter fills pouches made from the multilayer PVC-free film with the product and seals them with very little human intervention, reducing the chance of product contamination. It is the first time Baxter has used the Galaxy process for a biologic.
“It is our first Galaxy filing with FDA that went to the Center for Biologics and Research,” says Williams. “It is promising that this part of FDA found the process approvable for a biologic. We anticipate that [future filings using] Galaxy will have an easier path to FDA approval.” These may include switching existing products from other packaging formats, which Baxter offers to do on a contract basis for other companies.
Williams adds that the barrier film, which she declined to identify, has a high moisture-vapor transmission rate and high oxygen barrier, eliminating the need for an overwrap. Labeling and unit-of-use bar coding, which includes the National Drug Code, is printed onto the film.