|Product use||Product designed for providing a tamper-evident (cardboard/fibre tear) labelling feature on pharmaceutical cardboard boxes, supporting compliance with the Falsified Medicines Directive 2011/62/EU. Compliance is achieved by incorporating tamper-verification features as described in the European Standard EN 16679. This ultra-destructible product is irreversibly torn or broken when sealing labels are tampered with. The label can’t be re-used, further improving product safety.|
|Product||A clear, glossy, top coated, acrylate film with low elongation at break.|
|Tensile strength MD||60||MPa||ISO 527/3|
|Elongation at break MD||6||%||ISO 527||max.|
|Printability||Suitable for UV flexo, UV screen and UV letterpress; other methods should be tested.|
|Tack min||7||N||FTM 9|
|Regulatory info||This adhesive is in compliance with the demands of the Code of Federal Regulations, Food and Drug Administration (FDA), 21 CFR Ch. I (April 1, 2011 edition) § 175.105.|
|Product||A white transparent glassine backing paper.|
|Tensile strength MD||6.6||kN/m||ISO 1924|
|Tensile strength CD||2.5||kN/m||ISO 1924|
|Total caliper||128 µm|
|Minimum labelling temperature||10 °C|
|Service temperature||2 °C to 60 °C|
|Shelf life||From date of manufacture: 12 months, under FINAT defined storage conditions (+20-25°C and RH 40-50%). Prolonged storage at higher temperatures and/or humidity levels will shorten the shelf life.|
|Product Information||The tamper-evident labelling feature is influenced by the design of the cardboard box and label, the type of varnish on the box, and the particular conditions of the application; it takes from several hours to days for the adhesive to develop tamper-evident functionality.|
|Additional info||Label corners should have a larger radius than normal (minimum 3mm). Matrix removal should take place directly after die-cutting to prevent adhesive "flowing" back, using large diameter roller, not a blade. Experience shows that higher machine speeds (compared to PVC White UD) are possible, with 3mm label gaps and 5mm radius corners. In general this product is suitable for manual and automatic dispensing. The face destruction when an attempt to remove the label is made, requires a specific adhesion to the substrate and is typically of a tearing type. To assist the tearing of the face film when applied to non-polar surfaces, security slits should be added. We recommend considering all parameters that can influence the adhesion, namely substrate, temperature, application pressure and dwelling time. Pharmaceutical change management with 12 months’ notice of any change. In combination with the 2-year shelf life of RP62 EU label materials from the time of manufacture, this gives a 3-year window for any requalification requirements.|
|Disclaimer||The performance of the product should always be tested in the actual application conditions. Our recommendations are based on our most current knowledge and experience. As our products are used in conditions beyond our control, we cannot assume any liability for damage caused through their use. Users of our products are solely responsible that the product is suitable for its intended application, and have determined such at their sole discretion. Users must comply with any applicable legislation and/or testing requirements for the finished article, and are responsible for bringing their products to market.
This publication does not constitute any warranty, express or implied, and is intended only for the recipient and cannot therefore be transferred to any third party. We cannot assume any liability for the use of our products in conjunction with other materials.
All our products are sold subject to UPM Raflatac’s general sales conditions, and you should ensure that any existing laws are observed.
This publication replaces all previous versions. All information is subject to change without notice.|