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Release liners are a critical component in the overall development and performance of medical products such as transdermal drug delivery systems, medical devices, advanced wound care dressings and other pharmaceutical packaging products. Release liners must be selected to provide consistent release performance and inertness in the end-use application while meeting increasingly stringent performance and regulatory criteria in regards to quality, cleanliness and purity. Careful evaluation and analysis is required to assure the proper release liner is selected for the drug or medical product under development.

Release level and liner film should be selected to enable the end user to easily remove the release liner. (Source: Saint-Gobain)Adhesive formulations can vary widely containing tackifiers, wetting aids, viscosity modifiers, fillers and other additives, which can impact release performance. The drug loaded into the adhesive adds another layer of complexity and unknowns until the compatibility of pharmaceutical ingredients with the release liner materials is determined. Considering the many factors involved, evaluation of several candidate release liners fit for function is a recommended key step in the medical liner selection process.

Release liners provide several functions in medical device manufacturing and pharmaceutical packaging. They package and protect a wide range of products. Liners are also process carriers enabling easier handling, converting and assembly without the adhesive medical products sticking together. Release liners consist of a release coating on a plastic film, paper or cloth substrate. Medical release liners typically utilize plastic film substrates. Medical release liners are manufactured on high-speed roll-to-roll or web coating machines under cleanroom environments to precise coating weights. After deposition onto the substrate, the release liner coating is dried or set using heat or UV light.

Click here to read Saint-Gobain's free white paper about NORFILM™ medical grade release liners.