Extractables & Leachables in OINDP & PODP's

    The examination of extractables & leachables in OINDP & PODP’s from the primary packaging of drug delivery devices is growing in importance. This increased focus on medical package analysis has risen from various guidelines produced by the FDA - e.g. Guidance for Industry - Nasal Spray & Inhalation Solution, Suspension, & Spray Drug Products – CMC (2002) & Guidance for Industry - Metered Dose Inhaler & Dry Powder Inhaler Drug Products – CMC (1998). Such guidelines indicate that an assessment of the safety & compatibility of packaging & closures should be conducted during the early stages of a new drug or formulation.

    Our consultant team at Smithers Rapra is experienced in conducting three main stages of the assessment of extractables & leachables in OINDP & PODP’s, as recommended by the PQRI: Leachables, Extractables, and Routine Extraction Testing. We follow all extractables & leachables testing regulations and perform medical package analysis to ensure that the integrity of your drug product remains intact.

    To contact a specialist for assistance with medical package analysis, please contact:
    Europe: +44 (0) 1939 250383
    North America: (330) 577-3992

    Get more information on services for extractables & leachables in OINDP and PODP.