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Date07.05.2019 SI
Sales CodeFVL/RPMD/03
Product useProduct designed for labelling medical devices and healthcare applications when low leachable characteristics are required. This product performs well on small diameters and curved surfaces, and on a variety of labelling substrates including PP, PE and glass and it retains its adhesion through all the main sterilisation methods. This gloss product is the optimal choice for IV bags and bottles and for variation of drug delivery system devices.
Typical technical values
ProductMachine coated, glossy, woodfree SC paper. This face paper is made from FSC™-certified (mix credit) pulp.
Substance65g/m²ISO 536
Caliper59µmISO 534
Brightness88%ISO 2470/1
Roughness1.0µmISO 8791PPS 10
Opacity85%ISO 2471
Gloss72%Hunter 75°
CIE Whiteness110%ISO 11475
PrintabilitySuitable for offset, flexography and gravure printing methods (UV and water based inks).
Luminescent levelMin. 8 on the Laetus scale
SustainabilityThe product is sold as FSC™ Mix Credit under UPM Raflatac's FSC certificate SGSCH-COC-004879.
TypePermanent adhesive
CompositionAcrylic, waterborne
Tack18N/25mmFTM 9
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.
ProductYellow transparent glassine backing paper.
Substance57g/m²ISO 536
Caliper51µmISO 534
Tensile strength MD6.2kN/mISO 1924
Tensile strength CD2.3kN/mISO 1924
Transparency49%DIN 53147
Total caliper131 µm
Minimum labelling temperature-10 °C
Service temperature-20 °C to 80 °C
Shelf lifeFrom date of manufacture: 24 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 InformationStiffness of the face material, die-cutting direction, storage conditions and the container diameter can influence to edge-lifting. Note also that heavy ink coverage and overlamination increase the stiffness of the face material.
Additional infoPharmaceutical change management with 12 months’ notice of any change. In combination with the 2-year shelf life of RPMD label materials from the time of manufacture, this gives a 3-year window for any requalification requirements.
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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