For an international Phase III study of a new immunoglobolin, CSL Behring relies on a novel label combination from Schreiner MediPharm: With a special Flexi-Cap version that completely covers the vial and a Booklet-Label for multilingual product information, the vials containing the drugs to be tested are reliably blinded.
CSL Behring uses transparent containers with a flip-off cap for the clinical trial. Due to the visible differences between the verum and the placebo, the containers with the trial drugs have to be blinded because the trial participants must not be able to detect what they are taking or what is being dispensed to them under any circumstances. In addition, the trial is conducted on an international scale so that the product descriptions have to be available in several languages.
Schreiner MediPharm’s CTS experts developed a special combination of the Flexi-Cap film cap solution and a Booklet-Label. For blinding the vials, two opaque-printed, silver-colored film caps are used. One of the caps wraps around the closure and upper part of the container without covering the flip-off cap. As a result, the vial can be easily opened without impairing the blinding. The second cap covers the lower part and bottom of the container. A multi-page Booklet-Label providing the comprehensive product descriptions in several languages retains both caps on the container. The construction of the caps plus Booklet-Label is manually affixed using special application aids and can be flexibly adapted to diverse vial sizes and shapes.
Compared to other label solutions, which are complex to apply and can be easily peeled off, this combination of Flexi-Cap and a Booklet-Label has special advantages. It offers fast and reliable blinding combined with clear and efficient marking of the vials.
About CSL Behring
CSL Behring is one of the leading international biotech companies and was established more than 100 years ago. The company is a specialist in plasma-derived products and develops, produces and markets biopharmaceuticals for bleeding disorders, immunoglobulins and intensive-care medicine.