For an international Phase III study of a new immunoglobolin, CSL Behring, one of the leading international biotech companies headquartered in the US, 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, according to the company, to be tested are reliably blinded.
Schreiner MediPharm, a business unit of Schreiner Group based in Oberschleissheim near Munich, is a leading developer and manufacturer of innovative, multifunctional specialty labels and marking solutions with value-added benefits for the healthcare industry. The company has a production site in the United States. Products are manufactured for the North American pharmaceutical market in Blauvelt, New York. The company is represented in more than 20 countries, including India, through its network of specialists.
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 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, the company said.
Blinding the vials
Schreiner MediPharm’s 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 offering 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 booklet-label claims to have special advantages. The company claimed that it offers fast and reliable blinding combined with a clear and efficient marking of the vials.