March, 2003

Last year two New England based pharmaceutical companies hired Superior Controls- each with the same goal: to tie together their separate automation areas with several different PLCs into one industrial network. These separate areas or "islands of automation" had been installed over the years with different controllers that came from different parts of the world. They included:

• CIP: Allen-Bradley SLC 5/04Fermentation: Allen-Bradley SLC 5/03Filling: Siemens S7-300Packging: Omron C-200Conveyor system: Modicon MomentumLyophilizer: Allen-Bradley 5/50HVAC: Andover Controls
• HVAC: Siemens

The objectives of these two fast-track projects were the same:

• Connect the different systems into one common 21CFR Part 11 compliant database for each company to use for alarming and monitoring purposes.Provide the ability over corporate network segments to access Electronic Batch Reports and Down Time Reports.Implement the new systems in a manner that minimizes any manufacturing disruption and does not require revalidation of the existing systems.
• Packaging: Omron C-200

Fortunately, Superior Controls has an engineering staff of more than 20 experienced engineers- each with specific experience with the existing PLCs. With these resources, Superior designed PC-based systems communicating through the appropriate industrial networks (Data Highway, DH485, Profibus, Modbus, Ethernet) to communicate with most of the PLCs.

The existing code of each PLC was carefully reviewed to identify key registers and values to be monitored for alarm and production reports. The newly installed PCs were configured with Intellution's iFix and Microsoft SQL database to collect and store the appropriate information. Validation documentation was provided throughout the course of each project to ensure that the system was compliant with the FDA's regulations including 21CFR Part 11. This also required providing an automatic, always on, audit trail that would record any changes to electronic batch records including who made the change, what change was made, and the time and date of the change.

Finally, each server was configured with a RAID 5 (Redundant Array of Independent Disk Drives) disk backup system. In this way a failed hard disk could be replaced without turning off the power and the disk would be reconfigured automatically without losing valuable data. The servers also were configured by Superior Controls to provide HTML-based reports over the existing intranets. Therefore, all employees attached to the companies' intranets could simply call up the Electronic Batch Reports using their built-in browser.

Now our customers can easily access their 21CFR Part 11 compliant electronic batch records from their offices.