As it has direct contact with the drug product, testing of primary packaging is vital. In addition to ensuring the packaging material is suitable for end-use throughout the lifetime of the product, analysis of primary packaging is also an important regulatory requirement.
Full suite of testing
RSSL provides a full suite of primary packaging testing services. We can conduct routine pharmacopeial tests on packaging systems (syringes, vials, stoppers, glass etc.), including physical tests of packaging components for optimisation of quality and performance. We can also offer container closure integrity testing to certify containment and protect the dosage form.
Additionally, we can establish generic characteristics of your primary packaging, such as identity and composition, biocompatibility and general physicochemical properties. We can undertake extensive extractables and leachables studies to ensure that no chemicals transfer from the packaging into the drug.