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Condition Monitoring in Pharmaceuticals

 

Invitrogen Building

 

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, temperatures and pressure differentials. The manufacturing areas included gowning, filling, finishing, formulation, airlock and stores.

 

Solution

Measurement Systems proposed and installed the Orchestrator SCADA monitoring software running on the Microsoft Windows platform. The system was configured to acquire accurate and reliable data from an existing network of Datascan data acquisition modules, which are distributed around the facility. A new driver has also been developed for the Climet 500EM particle counter and 330EX multiport sampler. The Datascan units acquire data 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.

A feature for tracking changes to the system configuration was incorporated to record the time and any changes to the system configuration together with the operator in a CFR 21 Part 11 compliant audit trail. Any operator comments are also included and logged. 

Climet Particle Counter

Several Orchestrator Client licences were installed on PC's in the maintenance, office, laboratories and packaging area's, with visible and audible alarm indicators. The Orchestrator software provides a compatible audit trail of alarms, which include operator and operator station for acknowledgement of any alarm.

Invitrogen now have a machine monitoring systems that provides: 

 Benefits

  • Comprehensive measurement collection significantly increases the accuracy if 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.
  • Mr Peter Coelho from Invitrogen states "the system is simple and easy to use. The installation helps our users in Production, Quality and Engineering have a real-time view of all the different parameters being monitored. Out of specification alarms can be viewed and actioned immediately. Historic data is available to all users at the click of a mouse. Software and hardware support is quick and efficient, most problems can be sorted out over the phone."