MEETING PHARMA REGULATIONS: ENSURING LOW MIGRATION

LEIDEN, the Netherlands — 25 October 2011 — The new generation of drug containers and delivery systems face challenges that were not an issue for glass containers. Plastics such as LDPE, HDPE and PP are convenient, especially for small packages and where squeezing is required. They also offer higher efficiency, reduced breakage and lower costs.

However, plastic containers make the choice of label material far more critical. Components in inks, lacquers, top coats, adhesives, paper or film can leach through the container wall and contaminate the medicine inside. The container itself also needs careful selection to avoid leaching from the plastic wall.

The highest migration threat comes from solvent-based inks, UV inks, top coats and lacquers. There are strict regulations on migration of contaminants from packaging, and Avery Dennison has made compliance a priority. The adhesive Fasson® S692NP™ has been developed to perform well in applications with a high migration risk, such as fluid-filled linear low density polyethylene (LDPE) containers.

S692NP is a clear, permanent adhesive that adheres well to many tightly curved substrates including glass, polyethylene (PE) and polypropylene (PP). UV resistance and weatherability is also excellent. Extraction studies, comparing a range of adhesives on the market, show that S692NP reduces the risk of migration significantly. For example, one international pharmaceutical company abandoned qualification testing of alternative adhesives after finding that S692NP gave outstanding results.

Experience, expertise and global reach are important when producing compliant and reliable pharma labels. With divisions around the world, Avery Dennison offers a guaranteed product portfolio of dedicated pharmaceutical label materials, together with adhesives that meet the highest regulatory and compliance requirements.