The Challenge
A major pharmaceutical manufacture in North Carolina had a legacy BAS system in place that did not meet 21 CFR Requirements. Specifically the legacy system required many levels of user intervention to retrieve data that in the end did not meet 21 CFR compliance. The architecture of the system required many 3rd party utility drivers and programs due to its design. Each secondary network device contained a microprocessor and I/O boards that required specific utilities to communicate / update based on the make and model. The network was bundled with a variety of secondary network devices based on the application. This requires many versions of utility software to maintain, update, and violates the code for compliance. Due to the ability to manipulate data, no security on secondary network devices, and no audit trail; the system was deemed not compliant. The cost to upgrade this system to achieve full compliance would require a complete over haul of the network devices, software, communication wiring, workstation, and most importantly re validation of the “control” and the “monitoring” parameters of the system. PCI was asked to provide a more cost effective and timely alternative to upgrading the legacy system.

The Solution
PCI determined that the monitoring functions required bringing the legacy BAS system into full compliance could be provided by a GE/Kaye Labwatch® monitoring system. The renovation cost of an existing BAS is typically twice the cost of a newly installed 21 CFR monitoring system (GE/Kaye Labwatch) and this is not including the requalification cost and the “control” parameter of the renovated system being requalified. The GE/Kaye Labwatch is a monitoring only system so it can be installed to monitor the conditions of critical areas serviced by a legacy BAS. This approach eliminates the need to validate the legacy BAS.

The advantages to this approach, one system for control and one system for monitoring are cost and compliance. The advantages of the GE/Kaye Labwatch system are end user simplicity and data virtual real time. The “Host” buffers all the data where no field modules do so. This keeps the field modules strictly as an I/O device with no microprocessor. The speed of the system is gained from this design. Security, expandability, and robust hardware are other positive attributes to the system. The system is truly for monitoring only.

As a “preferred installer” for the GE/Kaye Labwatch® monitoring system, PCI was able to provide a turnkey GE/Kaye Labwatch® monitoring system. PCI services included installation, qualification and user training. High emphasis was placed on close coordination with the client to minimize operational impact on the owner and lost system availability. Use of the GE/Kaye Labwatch® monitoring system is a proven approach - PCI installed this system for six clients in 2004 and by March of 2005 will be three more clients.

The Result
• PCI installed a GE/Kaye Labwatch® monitoring system, supported qualifications of the system and provided operator training.
• The installation was complete and operational after three months of the project award. This compares to an estimated 9 to 15 months that would have been required for an upgrade and validation of the system.
• The project was completed on time and with budget. Total project cost, including the GE/Kaye Labwatch® monitoring system, installation support, qualification and training, was about 45% less than the estimated costs to upgrade the existing system.


The Benefits
Benefits to the client include:
    • Substantially lower costs for bringing the BAS system into compliance.
    • Substantially less time and impact on plant personnel to bring the BAS system into compliance.
    • The GE/Kaye Labwatch® monitoring system provides additional features that benefit the client such as: the “Alarm or Excursion” state it can email designated users, voice call with values and conditions, paging, and other redundant security and notification capabilities. Each excursion response is automatically logged in the audit trail. Upon next user sign in, it forces the user to acknowledge the alarm and enter in a “corrective action” plan which is also logged in the audit trail.
    • The system supports calibration with a full calibration menu and utility that is apart of the front end software. The calibration menu has two point offset capability and each change is logged in the audit trail.

For additional information, contact:
Rodney Perkins
Raleigh, NC Field Division
Pharmaceutical Calibrations and Instrumentation, LLC.
(919) 781-7787 Ext. 236
(919) 250-8386 Mobile
www.pci-llc.com


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