Medicines and other healthcare products rely for their value, integrity and commercial longevity on a delicate balance between quality, safety and efficacy. When that balance is disturbed by issues such as product adulteration, the damage to patients, revenues and corporate reputation can be substantial.
That is why the pharmaceutical and medtech industries, along with their associated regulators, are paying increasing attention to testing requirements for extractables and leachables (E&L). Recent trends in product development and manufacturing have multiplied the risks of unintended chemical changes that could compromise product integrity either during the manufacturing process or on the shelf.
Extractables and leachables are organic or inorganic chemical compounds, such as antioxidants, lubricants, polymers and dyes, with potential to migrate into finished products from the container, container closure, delivery system, primary, secondary and tertiary packaging, or various manufacturing components.