MedImmune in Frederick: Using Ordinary Tools in Extraordinary Ways

MedImmune’s approach may help take the blame off automation for plant startup delays.

By Paul Thomas, Senior Editor

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Last year, MedImmune received ISPE’s Facility of the Year “Overall Winner” award for its new large-scale mammalian cell culture-based production facility adjacent to its Frederick Manufacturing Center (FMC) in Frederick, Maryland. It wasn’t so much the facility itself that was impressive but the process by which it was designed, built, and started up.

A key to the success was the approach to automating the site—namely, the development of a simulator that enabled the team to execute commissioning and qualification of the Process Control System offline; and the reliance upon the principles of ANSI/ISA-88 and standardized control modules to enable 44 different skids to be tested prior to shipping, ensuring ease of integration.

We spoke with Brent Hill, director of automation within MedImmune’s Global Engineering organization, and Victor Ronchetti, Sr. VP and technical director for Automated Control Concepts, which worked with MedImmune on the system integration. The two presented together last fall at the Rockwell Automation Fair in Chicago, and answer questions collectively below.

“Automation is always to blame for slow startup,” said Hill recently, speaking at the Rockwell Automation Fair in Chicago. This project was an attempt to change that. Said Ronchetti, his co-presenter, “The S-88 approach and tools allowed a true ‘black box’ testing approach . . . We took the spotlight of the project schedule off of us.”

PhM: Your Automation Fair slides were titled, “Using Ordinary Tools in Extraordinary Ways.” What was the impetus to do something extraordinary and, in your mind, what is truly groundbreaking about the project?
Hill, Ronchetti: We had recently just finished a large “Pilot Plant” project similar in nature to the one in Frederick, Maryland. We had learned that we would need to do something that was extraordinary to meet the aggressive schedule. Therefore, we set in motion several systems, such as the Factory Acceptance Test Process Automa­tion Core (FATPAC) and code control, to position ourselves for success. 
As most projects go, there are unforeseen events that involve patience and adaptability.  Near the completion of the project we were given a completely new set of built P&ID’s.  The control system had already been designed around the design documents.  We were now faced with the task of re-coding and re-execution of the Process Control System (PCS) SAT. 
Due to competing deadlines, MedImmune was now faced with a nearly vertical schedule where the constraint was the physical equipment in the facility.  To stay on schedule, the automation team used Rockwell Softlogic’s software to completely replicate the process control system in its entirety. As shakedown activities took precedence in the schedule, it was necessary for the project team to perform activities related to the commissioning and qualification of the PCS in parallel, without interrupting shakedown runs. Under the strain of limited time on equipment as a result of competing project phases (start-up and debugging of applications, train production operators, and running test batches), the project team developed a separate PCS simulator (in addition to the PCS simulator used for operator training) that allowed them to commission and qualify major aspects of the PCS without having to perform the work on the plant floor. This system, which simulates every Programmable Logic Controller (PLC) in the facility, provided a safe, equivalent environment to perform testing. Today, this simulator is used for qualifica­tion and tech transfers and has become the Medimmune standard for how we execute automation projects.

PhM: What about S-88 (aka ANSI/ISA-88) “worked” for this project? Do you think the drug industry is finally coming around to its value and using S-88 principles as common practice?
Hill, Ronchetti: Giving the specific control modules, equipment modules and phases to each of the appropriate vendors was key to the project’s success. With the regulatory nature of the pharmaceutical industry, companies are becoming more informed about the value of only validating these standard modules and then using them time and time again. We are seeing the majority of the companies in the pharmaceutical industry going this way on most, if not, all hardware/software platforms.

PhM: You had 44 skids from different vendors all over the world and expected them to have common data storage, a single domain controller, form, fit, function, etc. Did this prospect seem ludicrous when the project began?
Hill, Ronchetti: At the beginning of the project, we sent out in the bid specifications, our requirement that all skid vendors were to use our standard modules and our intersystem communications specification. Once the vendor understood what we were trying to accomplish, all but one not only accepted it, but were enthusiastic about it.  They realized how much easier it would make start-up and integration of the system as a whole.

PhM: You provided software modules to Type 1 vendors (e.g., bioreactor manufacturers) three years before startup. Is this type of advance requirement practical and applicable for most projects?
Hill, Ronchetti: Yes, being able to integrate skids into a system or systems with minimal downtime and communication are critical to the success of any project. MedImmune has integrated this practice into all automation projects, regardless if it is green field, retrofit, or additional scope.

PhM: How did vendors respond? Were there a couple that didn’t, shall we say, “see the light”? Any that backed out of the project?

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