IVAX - Continuous Improvement in a Validated Process
Client
IVAX Pharmaceuticals based in Waterford, Ireland (part of global Teva Pharmaceutical Industries Ltd) specialises in the development, production and marketing of generic and proprietary branded pharmaceuticals and active pharmaceutical ingredients.
Industry sector
Pharmaceuticals.
Challenge
Achieving Continuous Improvement in a validated environment without incurring costly revalidation when production is in high volumes.
Solution
Batch supervision via Wonderware InBatch Software. Process Visualisation via Wonderware InTouch HMI. Quality measurement via Wonderware QI Analyst real-time data handling via Wonderware Historian. Downtime control via Wonderware DT Analyst.
Implementation
EmsPT consultants worked with Ivax and ONG Automation to deploy Wonderware integrated technology enabling OEE optimisation throughout the Ivax Inhalations production unit at Waterford complying with FDA21 CFR Part11. InBatch S88 structured approach divides batch preparation into phases that are validated in their own right - only the changed phases incur revalidation cost.
Operators can see the progress and status of each batch via the InTouch HMI visualisation software. QI Analyst attached to key components collects critical quality measurements which in turn generate alarms when trends indicate throughput is being compromised. All the data is archived in Data Historian which allows high volumes of data to be retrieved quickly. DT Analyst produced OEE calculations from data extracted off controllers and sensors positioned in the machinery without the need to change already validated code. Continuous Improvement is achieved by examining different data combinations to maximise OEE without incurring revalidation costs as the validated codes do not need to be changed
