The facility fills injectable breast cancer chemotherapy treatments. CFR 21 Part 11 requires that all equipment be validated (that is, operate at all times according to tight specifications), that operators be fully trained, and that all processes be executed according to well-defined, step-by-step procedures. In addition, all production components must undergo defined cleaning, sterilization, filling and product handling procedures.The facility was a greenfield plant consisting of a broad range of equipment from an equally broad range of suppliers. "A project like this, of course, is theoretically much easier in a greenfield situation," Robinson said, "and the equipment was skid-based, which should be ideal for plug-and-plan installation. The underlying objective was to wrap all the equipment, people and operations into a system that would be fully FDA-compliant at all times."However, for various reasons, many of the vendors were unwilling to supply equipment whose controllers were pre-configured to carefully-defined specifications. Controller brands included Siemens, Allen-Bradley and other types, depending on the penchants and validation testing of the vendors. In addition to the variability—and thus, potential for non-compliance—there were a number of processes that had situational fall-backs, or for one reason or another, had to be flexible."In the end, the project called for all the flexibility and engineering we could muster within ArchestrA on Wonderware," Robinson said. All told, 28 skids had to be corralled, with each operator, skid and procedure hewing to validated standards, and with every action recorded by batch, machine, time and operator."Even the electronic batch reporting had to be modified to include paper," Robinson explained. "The company's culture around engineering change control required that. 'Wrap and comply' take on new parameters for us on this project."Several time- and effort-saving routines were built into the system, including a universal log-in procedure that allowed operators to be logged in across the line with a single log-on, yet ensured that no piece of equipment could remain logged to any operator when he or she moved on."We even had to be flexible for equipment, where an operator could select from a menu of procedures or where the operator could take manual control for some sequence," Robinson said. "In some instances, depending on the operator's training and certification level, the operator could simply enter name and password, then proceed. In others, a second person, higher up the chain and closer to quality assurance needs, had to agree that the changes were compliant."Recipe management was easy for those vendors who complied with Avid's specifications—a validated recipe could be downloaded from the Wonderware database to the machine controller for each new operation. Each recipe, pre-validated, would automatically remain valid at the machine level.However, multiple vendors did not allow external downloads to recipe parameters. "To ensure compliance, we had to pull the validated parameters from the controller and compare the parameters with a second set of validated procedures in the database," he said. "If they matched, the process could continue."All in all, the basic concept remains intact: Wonderware and ArchestrA objects centralize and manage objects that contain pre-validated operations, control personnel access to ensure process certification, and collect data around time, machine, procedures and operators for every process.Robinson's bottom line summary of the project? "When vendors bully the owner, System Platform lets you be the hero by working around their inflexibility," he said. "As for complexity—mixed automated and manual systems are more complicated. Flexible, operator-centric systems are even more complicated. We learned that it is definitely best to begin with identifying the data required for reports, then work backward to define system functional requirements."
