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Janssen Pharmaceutical Manufacturing

When each little thing is really big

THE GIST:

A major expansion of a Johnson & Johnson-owned manufacturing plant brought a few challenges, some of them unanticipated. One was adjusting to a shortage of specified parts. Another was an extraordinarily small footprint for working. A third was the need to be spot-on with record-keeping to meet regulatory requirements.

When each little thing is really big

It’s said that the devil is in the details. Get a detail wrong, and you’ll pay the price.

This maxim was top of mind when we were working on a project for Janssen, the pharmaceutical arm of Johnson & Johnson.

Our assignment was to build and install mechanical, plumbing and process systems for a major expansion of a manufacturing plant – then go back and update systems in an existing section.

You have to be really careful in such an environment. You’re working in one area, and on the other side of the wall are solvents and chemicals that require delicate handling. So we had to move deliberately while doing our work and be especially vigilant for potential fire hazards.

The picture of piping intricacy: B&K fabricated a network of small-diameter piping to support Janssen’s plant.

Early on, one detailed matter to be figured out involved specifications for the project. They called for certain valves and components that wouldn’t be available in time to meet the project schedule.

“When you estimate a job, equipment and parts may be available when you’re specifying them,” says Project Manager Gordon Dunn. “But you might be awarded the job a good while later, when those same parts are in short supply.”

In the Janssen project, it wasn’t a matter of choosing another vendor. We had to figure workarounds – alternative valve types and other components that could be integrated into the project plan without any tradeoff of performance.

Notes from the Field

  • 9,200 linear feet of piping for addition and renovation of a pharma manufacturing facility
  • 1,140 LF of high-purity stainless steel pipe (fabricated in our clean room)

The picture of piping intricacy: B&K fabricated a network of small-diameter piping to support Janssen’s plant.

Shell and tube heat exchangers required both high-purity stainless steel piping and carbon steel piping to be installed on the same piece of equipment..

The renovation part of the project proved challenging for another reason. The area was a reactor room with an array of tanks and technology, all housed in a narrow facility. “This small footprint required us to carefully plan individual steps so that we could work in and around everything that was in the space,” says Jay Weldon, assistant project manager.

Here, our BIM modeling came in handy. We worked from a highly detailed view of all pipes, equipment and other elements in the reactor room. From there, we could determine the best approach for each step, taking care to ensure that the systems we built and installed would be easily accessible to maintenance teams in the future.

A third area of detail had nothing to do with engineering or construction – it was about record keeping.

“Because it was a pharmaceutical manufacturing facility, it had to comply with FDA regulations, and that meant we did too,” Weldon says. “We had to document where every valve was sourced, how we tested each piece and when we made adjustments. For example, we needed to create time-stamped images showing what we did before and after testing.”

All of the paperwork had to be turned over before commissioning and validation could proceed for the project. Fortunately, the careful documentation validated our process and work. The FDA saw that every detail was in place.

You have to be really careful in such an environment: You’re working in one area, and on the other side of the wall are solvents and chemicals that require delicate handling

Notes from the Field

  • 9,200 linear feet of piping for addition and renovation of a pharma manufacturing facility
  • 1,140 LF of high-purity stainless steel pipe (fabricated in our clean room)

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