Objectives To develop a science and risk based strategy to qualify a prefillable autoclavable cyclic olefin polymer (COP) syringe as a container for multiple drug products in a hospital pharmacy setting Methods Different extraction studies were performed with different solution characteristics: phosphate buffer batches (Na 2 HPO 4 / NaH 2 PO 4 in NaCl 0.9%) at different pH values, NaCl 0.9% batches, isopropyl alcohol (IPA) 5% in water and batches with Water For Injections (WFI) at different pH values. The filled syringes were terminally sterilised. The syringes were stored at room temperature (20°C±5°C). Following different monographs of the European Pharmacopoeia several tests were performed on the different batches. Analyses were performed at t=0,
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