The product is based on a one-layered wrap-around label called Pharma-Wrap and a two-layered Euro-Label
During clinical trials it is important to neutralise investigational products to ensure that the active drug and placebo cannot be distinguished from one another, so as to guarantee valid and compliant results. At the same time, there is a legal obligation to provide extensive product information in different languages for the drug being tested. This is a challenge for labelling, especially when transparent containers with small radii are involved. Schreiner MediPharm has developed a special solution for syringes with the Clinical Trial Supplies Unit of Sanofi, in Montpellier, France.
For use in clinical trials, the label must provide sufficient space for compulsory text. In addition, it must ensure that each investigational product has the same appearance, even in transparent syringe barrels. Depending on the required amount of text, a one- or two-layered wrap design is used for the syringe, each of which allows double-sided printing per layer of film. Extensive, high opacity printing of the transparent material is required to do this.
The special solution is based on a particularly long, one-layered wrap-around label called Pharma-Wrap and a two-layered label, the so-called Euro-Label. Very flexible film material is required, so that the label can be easily wrapped around the syringe with a small radius. The part of the label that is directly glued to the syringe consists of a tinted transparent film. This enables reliable neutralisation of the syringe without obstructing the view of the contents. The remaining part of the label is printed on a white background, so that product information can be provided on both sides. The integrated peel-open tab enables easy opening and closing of the label.
Schreiner-Medipharm says these special labels increase flexibility, efficiency, and safety for the execution of clinical trials, because one single label variant can be used globally for marking the respective product, while simultaneously blinding it.