The selection and assignment of packaging materials and components used for container closure systems and delivery of drug products provides another means by which unintentional substances may be present, to which patients may be exposed. Manufacturers have a responsibility to ensure that compounds resulting from interactions between the drug product and its packaging, throughout its shelf-life, do not give rise to compounds which are present at levels which present and unacceptable risk to the patient or consumer.
SAXOCON’s team of Toxicologists carry a broad technical experience in the review and selection of product packaging materials, coupled with their safety qualification. We maintain close relationships with competent analytical laboratories that specialise in the conduct of extractable and leachable studies. Following our product and packaging review, we can recommend the test methods and protocol appropriate to evaluate relevant materials and components of the product packaging. Subsequently, we are able to provide toxicological qualification of any relevant compounds resulting from extractable/leachable studies.