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RPMD

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Date08.05.2019 SI
AdhesiveRPMD
Sales CodeRPMD
TypePermanent adhesive
CompositionAcrylic, waterborne
UseDesigned for identification labelling of containers and packaging materials used in the medical device and healthcare industry where sterilization resistance, mandrel hold and low leachable characteristics are needed.
Typical technical values
Tack18N/25mmFTM 9
Labelling temperature min-10°C
Service temperature min-60°C
Service temperature max134°C(Steam autoclave, for 20 min.)
Additional infoRPMD has good adhesion on glass, cardboard, COP/COC, sterilization pouches, PE and PP surfaces. RPMD retains its adhesion in steam sterilization, gamma irradiation, e-beam and EtO-sterilization. Stiffness of the face material, die-cutting direction, storage conditions, label design and the container diameter can influence edge-lifting. Pharmagloss-FSC/ RPMD -laminate scored 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 approved RPMD according to European food contact materials’ requirements for direct contact with dry and moist, non-fatty foodstuffs. In addition, labels coated with RPMD may be used to label food packaging materials. According to FDA regulations, RPMD may come into direct contact with dry foodstuffs, or it must be separated from foodstuffs by a functional barrier. RPMD is approved in terms of patient safety (migration tested) for labelling blood bags. The laboratory has EN ISO 17025 accreditation for analytics and ISO 17065 for certification.
Regulatory infoRPMD adhesive is in compliance with the demands of the Code of Federal Regulations, Food and Drugs (FDA), 21 CFR Ch. I (April 1, 2016 edition) § 175.105. RPMD meets the requirements of ISO 10993-5 and is considered to have no cytotoxic potential (tested with Pharmagloss face material). Raw materials of RPMD are compliant with EU 1774/2002/EC.
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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