Project Description:
A North American manufacturer of injectable drug products needed an FDA-Compliant method of monitoring and controlling their process. Applied Sciences Group’s customer purchased two Lyophilizers from an equipment manufacturer which like many OEM’s provided a bare bones system that did not completely meet their process documentation needs. The Manufacturing process must be in accordance with FDA regulation FDA 21 CFR part 11.

Approach & Results:
The project objectives were met by consolidating the two OEM-supplied GE iFIX SCADA nodes into one node SCADA server node running on a fault-tolerant computing system made by Stratus, Inc. Each Lyophilizer was setup to have an iClient workstation in the control room and an additional iClient workstation in the mechanical room.

Applied Sciences Group developed a Security Plan that laid out all of the tasks that needed to occur to secure the operating environment. The following was performed:

Define and implement eSignature: iFix, IHistorian
Define and implement Application Validator: iFix
Trigger reports at end of run with source of data being: iFix, iHistorian
Move historical data archive from iFix to iHistorian.
Optimize iHistorian

A Stratus Technologies FT 3300 server was selected and configured to provide:

1. Redundant storage data
2. Failsafe Backup system of Data Collection
3. Backup method of generating cycle reports (XLReporter)
4. A central means of insuring and protecting data
5. Expandability of the system was a selection criteria.

Applied Sciences Group provided a system that added the redundancy, reliability, integrity and consistency required to meet FDA regulations.