Process Alliance came in to lay out the processing areas, select equipment and develop an equipment cost estimate. Process Engineering and Engineering Technology Director John Quatroche led the charge. There was a 3-month time crunch, and in that time Process Alliance had to design the overall flow of the plant, design room layouts for maximum efficiency, and compile a cost-effective list of equipment needed in the complex plant.

The company wanted a factory that could handle batch sizes ranging from clinical trial sizes to full-scale production. Process Alliance developed a highly efficient overall plant layout which allowed a room-to-room process flow, eliminating the need to handle high volumes of liquid product streams by tote movement. This also allowed for much easier processing and a much smaller overall footprint for the building and afforded the ability to clearly separate product and waste streams.

Through working with equipment vendors, experts at Process Alliance were able to quickly develop an equipment list suitable for the large range of processing required as well as an equipment cost that was favorable given the complexity of the plant. Both the A/E firm and the pharmaceutical company were pleased with the work done by Process Alliance, and the pharmaceutical company was able to move forward in getting the new plant ready for production.

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The Process Alliance team—led by Process Engineering and Engineering Tech Director John Quatroche—was given three months to identify all of the current equipment and the flow rate of each piece; the company had no record of this when the team arrived. After that, the team was tasked with identifying the ideal flow rate for the 37% increase and determine if the current equipment could meet the demand.

The results showed that the plant did need new equipment, but the quick work gave them the time to request funds to supply it. Process Alliance provided them with more than just a solution to their issue: They also were left with information on equipment that they did not have beforehand. The project was short-term but required a large effort on the part of the three Process Alliance engineers that took it on. The company was left with more documentation and the ability to increase their production to the desired level.

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What was initially thought to be a smaller project turned out to be a much larger one, as Kahn and Perkins began working with the company full time from May until September. Due to the

failed inspection, the factory had updated its equipment, added new personnel, and updated all of their procedures. However, this left a larger issue: There were gaps in training between the employees, and the current system provided no way to discern who had been trained fully and where more training needed to be done.

The first step to solving the issue was for Kahn and Perkins to investigate the training gap. After assessing the staff, the Process Alliance team began building and adjusting the existing training courses. With the new and old machinery, it was important that each employee knew how to safely operate and use each instrument.

The levels of training varied. Some pieces of information need only be read by the staff, and then confirmed that they are understood. Others used traditional classroom training. More complex procedures required employees to demonstrate that they are aware of the steps and processes needed to complete certain tasks. In the last few months of their stay, a higher-level training system was begun that explained how equipment functioned and the science behind it.

Another key problem with the preexisting system was a lack of documentation. Kahn and Perkins increased the level of documentation and added a level of verification by requiring that a second staff member confirm steps had been done correctly after the initial employee has performed them.

In the end, the company was left with better-trained employees, more efficient systems, and higher levels of production. The company redid the batches they submit to the FDA and met their deadline of resubmitting within 12 months in order to keep their expedited status. The higher level of documentation showed that the staff was trained, and the multiple methods of training ensured that the education was reflected in their work. The plant is currently waiting for the FDA to come for a pre-approval inspection, but this story will be updated when more information becomes available.

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John Quatroche, Process Alliance Process Engineering and Engineering Tech Center Director, was contacted to solve the issue. The director of the facility knew Quatroche, and the company didn’t have experts on staff to calculate the blending time. Along with Quatroche, President Darren Thompson and consultant Ben Patterson worked on the project.

Normally, a blend time test would be executed in the tank. This hadn’t been done, and the facility didn’t wish to stall production in order to run one. However, once Process Alliance had the measurements, the job was quick work: The required blending time was calculated within the next day. It was a mere 23 seconds, proving to the agency that the original five-minute blending time was plenty to produce a homogenous, live-organism-free mixture.

“The director that requested our assistance was extremely happy with the speed and thoroughness of my approach, and of course that the story had a happy ending,” said Quatroche.

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The client did not have an engineering department, and the issues had been ongoing for over six months, with the OEM unable to diagnose the issue. Eventually the company wished to move from one shift of production to three, but the frequent ceases in production made this goal difficult and less productive than it should be. Moore, however, brought in his 48 years of experience and was able to solve the issue with ease. “In the first 15 minutes that I was in the plant, we had identified the major problem,” Moore said.

The cooling tunnel design and installation had led to humid room air leaking into the plenum, resulting in a telltale ice pattern on the coils. Don immediately recognized that pattern, which led to quickly finding the sources of air ingress. The OEM service representative had been unable to identify the problem. After the plenum was adequately sealed, Don further tuned the system’s product flow rate and temperature setpoint to optimize performance.

Following his assistance, the plant began the second and then third shift of production on their targeted days, and were able to run without stopping to defrost. Along with that, his help allowed them to minimize the microbial risk that comes with excess moisture.

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