Clinical chemistry system

Description

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. A custom-engineered system that shall process bottle formats associated with clinical trial studies. Specifically, the system shall: 1.1) Individually track and manage each bottle throughout the system. This includes primary packs (defined in 2.12/2.13) and their tracking and should include such information as hold time and expiration; 1.2) Work in a fashion that enables dust containment within active materials with Occupational Exposure Levels (OELs) in the region of 0.1 μg/m3/8hr time weighted average (ideally as an engineering solution within the platform); 1.3) Singluate bottles and closures, load desiccant in bottles as required; 1.4) Fill (to weight) hard capsule shells with API (drug substance) material and present these to the system for further processing; 1.5) Dispense tablets / capsules into bottles, cap and seal the bottles. 1.6) Accept manually entered pre-filled (capsules or tablets) bottles on an as required basis and send on for further processing; 1.7) Label filled bottles and consolidate bottle orders; 1.8) Dispense tablets/capsules into marked bottles for inventory; 1.9) Mark filled bottles for inventory; 1.10) Ensure damaged product is removed from the line and adequately disassociated from the order to maintain accountability. 1.11) Ensure that component and product relevant environmental conditions (temperature and humidity) are verifiable and if this is not the case that the product is discarded. The system shall be designed to process orders in the following modes: 1.12) JIT Center – orders to be fulfilled rapidly through the automated platform including potential for integration with manual quality assured systems, for flexibility, with potential for shipping the same day; 1.13) JIT Depot – orders to be fulfilled and shipped within a five (5) business day window with the potential for integration with manual systems as per 2.10; 1.14) Primary Packs (Introduction) – manual introduction of pre-filled bottles into the system where a unique ID is applied to each incoming product for tracking purposes. Note: This also includes the re-introduction of previously processed bottles; 1.15) Primary Packs (Creation) – applies to bottles only – generation of filled and sealed bottles of a specific drug product variant, identified with a unique ID, and held in local system inventory until required for an order; 1.16) The system and its components shall be controlled by PLC(s) and manage orders either via manual order entry or by information transfer to and from our partner companies’ (GSK and AZ) Enterprise Systems. With potential included in the design to ensure expansion of the communication capability.