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Date04.09.2019 SI
AdhesiveRP62 EU
Sales CodeR62E
CompositionWaterborne acrylic
UseDesigned to provide 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-evident features as described in the new ISO 21976 standard.
Typical technical values
Tack min7NFTM 9
Labelling temperature min10°C
Service temperature min2°C
Service temperature max60°C
Additional infoRP62 EU has good clarity, so it provides an easy way to add serial numbers or other information over existing packaging. 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 full tamper-evident functionality. Raflex Plus Clear TC / RP62 EU –laminate gets score 2 in a Sensory Analysis for Indirect Transition of Taste according to EN 1230-2 (Robinson test). Pharmaceutical change management with 12 months’ notice of any change. In combination with the 2-year shelf life from date of manufacture, this gives a 3-year window for any requalification requirements.
ApprovalsAccredited laboratory has given RP62 EU an approval according to the European requirements for direct contact with dry, non-fatty foodstuffs. In addition RP62 EU may be used for labeling food packaging materials. According to FDA regulations, RP62 EU may come into direct contact with dry foodstuffs, or it must be separated from foodstuffs by a functional barrier. The laboratory has EN ISO 17025 accreditation for analytics and ISO 17065 for certification.
Regulatory infoThis 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.
DisclaimerThe 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.

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