New Flexi-Cap for clinical trial supplies

Combining first opening protection with reliable blinding

Flexi-Cap for clinical trials: Non-blinded vs. completely blinded containers. The container on the right hand side shows the activated first-opening protection

Schreiner MediPharm, a leading developer and manufacturer of innovative, multifunctional specialty labels and marking solutions, has added a new product to its Flexi-Cap range.

Flexi-Cap is an innovative security solution that irreversibly indicates the first opening of primary containers which prevents illegal filling and reuse of empty containers with counterfeit substances. The development combines first opening protection with reliable blinding of transparent containers used in clinical trials. Thanks to opaque-printed film caps, investigational products cannot be distinguished from each other. In addition, an integrated Booklet-Label offers ample space for product information in different languages.

Product candidates in clinical trials must be reliably blinded in order to achieve optimum test results. There may be visual differences between the active drug and the placebo, such as different colours, which must not be discernible by the trial subjects. Consequently, when transparent containers are used, the label must meet special requirements. In addition, it is important to protect clinical trial supplies against tampering. Extensive product descriptions in diverse languages are another prerequisite for clinical trials to be efficiently and flexibly conducted in an international context.

Flexi-Cap for clinical trial supplies consists of a label and two opaque-printed film caps that completely wrap around the container. While one cap encloses the lid and upper part of the container, the second cap protects its bottom and lower portions. A Booklet-Label affixes both caps to the container and offers ample space for text. The new Flexi-Cap solution ensures reliable blinding of transparent containers combined with irreversible first opening protection thanks to a tear strip integrated into the upper cap.

Applied without heat, the solution consisting of the caps and label is suitable for temperature sensitive substances. Flexi-Cap for clinical trial supplies can be flexibly adapted to glass containers of various types, shapes and sizes and also protects them against glass breakage. Various colours with high opacity may be used for the caps. The lid of the film cap offers additional space which may, for instance, be used for imprinting with codes or for integration of NFC chips for interactive applications.

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