Measuresoft Case Study: Invitrogen

Invitrogen – Paisley, Scotland

Company Profile As a key partner in the global life science community, Invitrogen provides products and services that support academic and government research institutions as well as pharmaceutical and biotechnology companies. Invitrogen’s European headquarters are in Paisley, Scotland, near Glasgow. Situation Invitrogen required a system to monitor the ambient conditions in their Paisley production facility. It is a regulator requirement to ensure that ambient conditions are within range during production and that ambient conditions for a production batch are recorded. The ambient conditions include airborne particles, relative humidity, temperature and pressure differentials. The manufacturing areas included gowning, filling, finishing, formulation, airlock and stores. Solution Measuresofts UK partner, Measurement Systems proposed and installed the monitoring solution based on Measuresofts Orchestrator product running on the Microsoft Windows platform. The system was configured to acquire data from a distributed network of Datascan data acquisition modules and Measuresoft developed a driver to the Climet 500EM particle counter and 330EX multiport sampler. The Datascan units acquire readings from relative humidity, temperature and pressure differentials sensors. The Climet unit is laser diode based and can measure particle counts from up to 30 locations. The system was secured using Windows security to that operators using the system are clearly identified and their access to the system configuration, system alarms and recorded data is controlled.   Measuresoft provided a product feature for tracking changes to the system configuration so that the time and operator who changes the system configuration is recorded in a CFR 21 Part 11 compliant audit trail along with an operator comment. An Orchestrator client was installed on PCs in the maintenance, office, laboratory and packaging areas with alarm visible and audible indicators. The Orchestrator software provides a CFR 21 Part 11 compatible audit trail of alarms which include operator and operator station for acknowledgement of alarms. Invitrogen now have a machine monitoring system that provides: A fully integrated ambient monitoring solution Alarms if any ambient conditions are out of acceptable range. Audit trails of changes to the system and acknowledgement of alarms. Comprehensive tamper proof data logging for production records. Real-time and historical trending which allows an operator zoom into an area of interest and export that data to a standard Microsoft Excel report format. Benefits Comprehensive measurement collection significantly increases the accuracy of readings. Leveraging the Microsoft platform provides a solution that is accessible throughout the corporate network and uses Windows security for operator identification. Operator familiarity with the Windows user interface reduces training costs.