Blauvelt,  08/12/2020

Combination of Flexi-Cap and Booklet-Label Aids Clinical Research

Specialty Label Solution from Schreiner MediPharm Blinds Vials for Clinical Trial Conducted by CSL Behring

The combination of Flexi-Cap and Booklet-Label blinds the vial and offers ample space for product information in several languages.

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 global provider of innovative 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. 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.

 

For further information, contact:
Schreiner MediPharm, a business unit of
Schreiner Group LP
300 Corporate Drive, Suite 10
Blauvelt, NY 10913
Phone (845) 848-9000
Fax  (845) 848-9041
info@schreiner-medipharm.com 
www.schreiner-medipharm.com