For an international Phase III study of a new immunoglobolin, CSL Behring is relying on a novel label combination from Schreiner MediPharm, a Germany-based provider of functional label solutions for the healthcare industry. With a special version of Schreiner MediPharm’s Flexi-Cap solution that completely covers the vial, combined with a Booklet-Label for multilingual product information, the vials containing the drugs to be tested are reliably blinded.

CSL Behring is using transparent containers with a flip-off cap for the clinical trial. Due to visible differences between the verum and the placebo, the containers with the trial drugs must be blinded so trial participants cannot, under any circumstances, detect what they are taking, or what is being dispensed to them. In addition, the trial is being conducted on an international scale, so product descriptions must be available in several languages.

Schreiner MediPharm’s Clinical Trial Supplies (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 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 Booklet-Label has special advantages, the company says, including fast and reliable blinding combined with clear and efficient marking of the vials.