Key Regulatory Considerations For Flexible Containment Systems

By Alan George, Life Science Leader magazine

When looking at materials of contact for drug products, the pharmaceutical industry complies with a variety of regulatory requirements from multiple organizations. This includes tests for extractables, stability trials, and surface resistivity as new products work their way through the new drug application process.

The three primary areas of consideration when selecting a film for use in powder transfer or storage devices include electrical safety, food contact compliance, and regulatory compliance. This article concentrates on the new requirements for materials of contact used in the EU.