1171 - Innovative JIT Clinical Pharmacy for the Supply of Solid Oral Dosage Forms

System to process bottle formats re clinical trial studies. Capable of individually tracking & managing each bottle end to end, including info re hold time & expiration. Dust containment within active materials with OEL in the region of 0.1 µg/m3/8hr time weighted average (ideally as solution within the platform). Singluate bottles & closures, load desiccant in bottles. Fill (to weight) hard capsule shells with API (drug substance) material. Label filled bottles & consolidate bottle orders. Dispense tablets/capsules into marked bottles for inventory. Ensure component & product relevant environmental conditions (temp & hum) are verifiable. System designed to process orders JIT rapidly through automated platform for shipping same day & 5 day, with potential for integration with manual systems. System & its components shall be controlled by PLC(s) & manage orders to & from our partner companies’ (GSK and AZ) Enterprise Systems. Design to ensure expansion re communication capability.