When working on process development studies for manufacturing equipment, it's essential to make the test environment as similar to the production environment as possible. I remember dealing with a filling machine that used several peristaltic pumps. The accuracy of how much it filled was really affected by the pressure coming from the supply vessel before it.

In the maintenance shop, this new filler worked great. But, when we moved it into a clean room, controlling it became much harder. We found out that using a sterile filter on the discharge port was fine as long as everything—the equipment and the filter—was at the same room temperature. But in the clean room, the problem was the incoming formulation was warm while the filter stayed cool. This temperature difference caused vapor from the product to condense on the filter's pores. It led to a clog that then made the vessel's pressure fluctuate during discharging and refilling.

So, the issue wasn’t with the filling machine itself—it could do its job as intended. The problem was that the overall process it was part of added more variability once installed.

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