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

Descriptions

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