By Andy Goll, President, Weiler Engineering, Inc.
As researchers continue to discover new possibilities in patient care, the need for safe and efficient delivery systems for biopharmaceutical drugs intensifies. For injectable drugs, the most common primary packaging containers have traditionally been glass syringes and vials; however, glass packaging presents several challenges, such as absorption, delamination, glass breakage, risks of breakage, design limitations, a lack of flexibility, and multicomponent systems. Multicomponent filling and sterilizing systems present their own challenges when you need to integrate multiple pieces of equipment to accomplish the following in one packaging line: washing, filling, sterilizing, and capping the vials, applying a label, etc. In many cases, special attention needs to be given to incoming raw material control of the rubber stoppers due to the presence of silicone and the potential presence of particulates. This has created pressure on drug manufacturers to come up with alternative methods for a safe and reliable approach to delivering new and innovative life-saving therapies.