FDA approval for E3 IV containers

B. Braun approval for next generation 1L intravenous containers manufactured from biologically inert, using non-toxic plastic materials.

February 5, 2014
Manufacturing Group
Contract Manufacturing Design/Engineering Industry/Regulations Materials People/Facilities

Bethlehem, Pa. - B. Braun Medical Inc. received FDA approval of 5% dextrose and 0.45% sodium chloride injection USP in 1L IV containers. B.Braun's E3 IV containers are a first of its kind offering that will provide healthcare professionals with the highest quality, easy-to-use IV containers that are not made with natural rubber latex, DEHP, or PVC. 

"B.Braun's commitment to increasing capacity to meet market demands has never been stronger, as evidenced by our investment in the next generation of IV container offerings," says Rick Williamson, vice president of pharmaceutical marketing at B.Braun. "The approval moves B.Braun towards its goal to increase capacity by 15% over the next 12 months," added Williamson.    

B.Braun continues to lead the way in offering the only full line of IV solution products that are manufactured using non-toxic plastic materials – a true testament to B.Braun's ecological awareness and patient-centric philosophy. With the addition of the new E3 IV containers, B.Braun will expand its line of solution containers that are not made with natural rubber latex, DEHP or PVC. Exposure to these toxic materials has been a growing concern for healthcare facilities around the world. Studies show that excessive exposure to DEHP can potentially lead to adverse health effects, especially to a patient's liver, kidneys and lungs, as well as their heart rate and blood pressure.1 More than three decades ago, B.Braun recognized the environmental and patient risks posed by products containing DEHP and PVC. As a result, B.Braun was the first medical device manufacturer to remove these harmful substances from many products and today is the only supplier that offers a full line of solution containers that are not made with DEHP or PVC. B.Braun is keenly focused on continuing to find alternative methods to manufacture safer products such as the E3 IV containers.

About E3
E3 IV containers are manufactured biologically inert, using non-toxic plastic materials. The innovative, blow-filled technology used during manufacturing provides a seamless container design for safe, rapid, and accurate fluid delivery. The sturdy port system allows for easier set access and medication additions. The lack of over wrap makes E3 environmentally friendly and easy to store at room temperature. 

1 http://www.wsna.org/Topics/Workplace-Environment-You/Environmental- Source: B. Braun Medical Inc.