Water for Injection Equipment in a Tight Space

The Challenge - The Modular Design

Paul Mueller Company pharmaceutical equipment is often assembled in our large Springfield, Missouri, manufacturing space. Once it's carefully crafted, it's mounted on a frame and shipped to its final location. However, when faced with limited access and tight quarters, we can design a unit to be broken down into several smaller pieces and then re-assembled on-site at the customer's facility, as we did for this customer in St. Louis.

The Journey - The WFI Process

We received a call from a customer in St. Louis, and they still needed a new multi-effect still. This particular facility does some contract manufacturing. Their parent company provides some base products for pharmaceuticals. They still boil high-quality water to remove any of what’s called pyrogens. A pyrogen is anything that, if introduced into the body, can cause infection. Removing the pyrogens basically makes this water for injection. This water is safe to inject into your body and can not cause an infection.
 

The Solution

In this case, they wanted a unit that produced water and steam, so we designed a combination unit for them. So the original design, where this had to go, was on the 3rd floor, and there was no elevator access to the 3rd floor except going through a sterile environment. They had an air handler sitting in this building, and so the air handler was moved and put on the roof, so this left this room for us to stick this in. The challenge then, of course, was to get a very large unit in manageable pieces. The unit had to come in in enough pieces to be staged in a hallway downstairs, then put on hand carts and hand trucks, and then wheeled into an airlock chamber. Everyone had to gown up and cover the equipment. The equipment then had to go through the sterile process area and to the elevator, then up to the third floor, and then into the actual mechanical room. So, all these pieces were assembled up and put into the unit.

The Results

Taking a still and pulling everything off the frame, and then having all the frame components reassembled onsite by hand was quite interesting.  A lot of thinking went into this to make it happen. We put the thing back together in 4 days. So we went from having everything in crates, lined in the hallway – to getting it upstairs, re-assembled, and ready for piping and electrical in 4 days! Out of all of the 13 crates, we lost one piece of ¼ inch (0.6 cm) tubing about 2 feet (61 cm) long. Hats off because every bolt, every nut was there, except one piece of tubing.

We worked really well alongside them to meet their needs, to adapt and break this down and get it into their room the way we did. That’s one of the things appealing to the customer based on their comments. For what we have the ability to do with our engineers, our designs, our fabrication crew, we can meet anybody’s needs in the pure water, clean steam department, and we have a good crew.

The customer is definitely pleased. They were very pleased in their comments about how responsive we were in solving this issue and how everything went together. The main maintenance guy there had nothing but praise for how the machine looked. He named the machine Norma Jean. He names all his machines, so Norma Jean is happy, and he’s happy with Norma Jean!