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Today, labels of investigational products have become multifunctional tools that are able to convey variable data in different languages, blind contents, indicate first opening or support ease of use.
Clinical trials are not usually limited to a single participating country but conducted in several countries. As a result, the labelling of investigational medicinal products has to accommodate an increasing number of languages. Labels may have to be printed in up to 40 different versions. Each language is having its own label, which means having to produce 40 label variants in the volume required before applying and distributing them. Separate batch documentation is required for each label version so that the paperwork involved is immense.
Another option is to integrate several languages into a single product. This can be achieved by using so-called booklet labels, available in up to 113 pages. These provide an all-purpose solution that can be applied in every participating country. Booklet labels are a combination of self-adhesive labels and leaflets. Thanks to their large volume, they can accommodate all languages in a clear structure and readable font size.
Regardless of whether complete marking is achieved by means of one-layer, multilayer or booklet labels, labels should always match the shape of primary packaging. For instance, vials, pens, syringes and inhalers can be labelled in different ways. Wrap-around labels are particularly suitable for small-diameter cylindrical containers. Wrapped around cylindrical bodies several times, these labels can be resealed after each opening.
Unusual shapes tend to require a high level of creativity, know-how and experience from label manufacturers. Departments dealing with research and development are therefore becoming increasingly important. Labels are developed individually and tested for criteria such as adhesion and adaptability as well as user-friendliness. Label performance during application can be simulated at Faubel or tested at the investigational drug manufacturer’s facilities.
Booklet labels are often enhanced by additional functions. For example, should an infusion bottle require labelling, then a label with an integrated hoop for hanging the bottle offers improved ease of use. Another way of optimising the subsequent use of investigational products is to add documentary sections to labels. In this case, booklet labels are supplemented by one or several documentary stickers featuring trial-specific data to provide complete and accurate documentation; for example, in patients’ medical reports.
Pharmaceutical manufacturers often face the challenge of having to blind their investigational products adequately to make sure that investigators, nursing staff, participating patients as well as data analysts are unaware of the treatment assignments. It is the only way of precluding unwanted biases in trials. The type of product selected for blinding depends on the primary packaging of the study drugs. Vials, bottles, pots, jars and tubes can be fully covered. Optimal blinding can make the time-consuming colour matching between liquid placebo and active substance unnecessary. Some blinding solutions can only be used for single-blind trials, some others for double-blind trials. They may be completed with various options such as Braille embossing, variable data, security features such as tamper-evident features or a code-break function.
Vials can be blinded by using boxes made of opaque and robust cardboard. As a result, the volume and the height of the containers as well as the colour of the contents are entirely masked and therefore unidentifiable. Boxes can be printed on the inside in colour in order to give the active substance and the placebo groups the impression that both trial products are the same colour. Furthermore, a control window can be added to these boxes. If it needs opening for some reason, it will become immediately visible.
Pharmacists and contract packagers often use labels to blind tubes, jars or pots. Once labels are glued on tubes, it is impossible for trial staff and volunteers to tell the placebo from the active substance.
If trial-specific data needs additional masking, printable laser fields, scratch areas and sections with code-break function can be subsequently incorporated into the secondary packaging.
Secondary packaging for investigational products have changed into flexible, though compact, multifunctional tools.