FDA Clears New B. Braun Non-Toxic IV Containers

B. Braun Medical Inc. has received U.S. Food and Drug Administration (FDA) approval of its E3 5 percent dextrose and 0.45 percent sodium chloride injections USP (United States Pharmacopeia) in 1 liter intravenous (IV) containers. According to the Bethlehem, Pa.-based medical products company, these containers are trhe first of their kind 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,” said Rick Williamson, vice president of pharmaceutical marketing at B. Braun. “The approval moves B.Braun towards its goal to increase capacity by 15 percent over the next 12 months.”

B.Braun offers a full line of IV solution products that are manufactured using non-toxic plastic materials, which is part of the company’s stated 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. More than three decades ago, B.Braun recognized the environmental and patient risks posed by products containing DEHP and PVC, and removed these harmful substances from many of its products.

The E3 containers manufactured biologically inert, using non-toxic plastic materials. According to B.Braun, the blow-filled technology used during manufacturing provides a seamless container designed for safe, rapid and accurate fluid delivery. The sturdy port system allows for easier set access and medication additions. The container does not have an over wrap, which is intended to make it environmentally friendly and easy to store at room temperature.

The company also just announced a $75.5 million investment into expanding its pharmaceuticals plant in Penang, Malaysia.

B. Braun Medical focuses on infusion therapy and pain management products.