Special label of Schreiner MediPharm blinds vials for clinical study by CSL Behring

For an international phase III study on a new immunoglobulin, CSL Behring relies on a novel label combination by Schreiner MediPharm: With a special flexi-cap variant that completely covers the vial and a booklet label for multilingual product information, the vials are reliably blinded with the preparations to be tested.

CSL Behring uses transparent vials with a flip-off cap for the clinical study. Since verum and placebo have optical differences, the containers must be blinded with the test preparations - because the study participants must not be able to see what they are taking or being administered. In addition, the study is international in scope, so the product descriptions must be available in several languages.
Schreiner MediPharms CTS experts developed a special combination of the film cap solution Flexi-Cap and a booklet label. Two opaquely printed silver foil caps are used to blind the vials. One cap encloses the closure and the upper part of the vial. The flip-off cap is not covered so that the vial can be easily opened without affecting the blinding. The second cap covers the lower part of the vial and the bottom. The two caps are fixed in place with a multi-page booklet label that provides comprehensive product descriptions in different languages. The construction of cap and booklet label is applied manually with special application aids and can be flexibly adapted to different vial sizes and shapes.
Compared to label solutions, which require complex application and can be easily removed, the special combination of flexi-cap and booklet-label has particular advantages. It offers a fast and safe blinding and at the same time a clear and efficient identification of the vials.
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