Seidenader BIM Detects Particles and Cosmetic Defects
Seidenader Maschinenbau have developed an automatic inspection method for flexible IV bags. In cooperation with one of the most important suppliers of IV products an efficient automatic inspection machine was designed combining a unique handling concept and high resolution cameras.
Seidenader BIM inspects bags for visual particles in solutions, correct welding of seams and the functionality of ports and connections, at speeds of up to 150 containers/min - from 50 ml up to 1,000 ml without requiring change parts. A special focus was set on an ergonomic design and a machine concept that can also handle a worst case of product breakage which might spill 2-3 liters of liquid onto the machine table.
The market share of IV bags has been increasing continuously - especially in the area of large volume parenterals. The advantages are obvious: Bags are light, transparent, and they do not break as easily as the typical IV glass bottles. This makes them predestined for frequent use in hospitals, ambulances and by the military.
However, bags have to be inspected for particles and cosmetic imperfections just as any other parenteral product. Due to the flexible nature and its oval shape this was difficult to automate in the past.
With Seidenader BIM, operators don't have to handle heavy bags anymore. This weight, which could be several tons per day in routine operation, often leads to carpal tunnel syndrome from repetitive motion and fatigue over time. The inspection process becomes more consistent and follows pre-defined parameters that make the validation process faster and more transparent.
Seidenader BIM meets the cGMP and GAMP regulations and will be documented to FDA acceptable standards.