2013 - EMEA Industry Session - Pharmaceuticals, Food and Specialty Chemicals
Combining Laboratory and Process Data on the PI System
Material Critical Quality Attributes (CQA) are a series of lab test results in ELIMS for batches produced on site. This data represents actual process quality attainment for batches produced on site for the market. The data is used for Continuous Process Verification (CPV) and is also analyzed for trends and variations. Deep understanding of this data and how production methods affect it is key to not only satisfying CPV regulatory requirements, but enabling identification of business and process improvements in areas such as yield and cycle times.
To meet these requirements, site leadership identified the need for a centralized data facility with both Production Data and ELIMS Result Data readily available to the end user on one system. ELIMS results are inherently linked to critical production steps and the actual performance of processes and equipment affect these results. Given that all production data such as continuous processing parameters and batch context data are already on the PI System and that end users use PI System data extensively on a daily basis, the PI System is the obvious choice to facilitate this.
This presentation shows how Janssen used the PI System to link ELIMS data to production/ batch data and how it empowered the users by giving them the facility to not only view ELIMS data on simple charts, but also by enabling them to visualize this data with relevant critical processing parameters together on a single display for comparison and analysis. In addition, Janssen is exploring new ways of visualizing Stability Data and is piloting schemes to bring this data to the user through similar visual displays with advanced search and retrieval functionalities.
- Pharmaceuticals & Life Sciences
Janssen Pharmaceutical Companies of Johnson and Johnson
Kevin Crean has worked in the pharmaceutical industry for 20 years and spent a large portion of his career in instrument and automation design engineering consultancy before joining Johnson & Johnson in 2005. Since then he has worked in the Manufacturing Systems Department at Janssen Chem, Cork, Ireland. His roles include technical ownership, administration, support and project implementation of manufacturing systems such as their ABB 800xa, ABB Sattline, Automation Networks and OSIsoft PI System.