When every move has to be right

Requalification measurements in cleanrooms are a sensitive matter. For this reason, production or operation in these rooms is usually suspended during the measurement activity. If “in operation” measurements are required, the processes (for example the production of medicines or technical components such as semiconductors) are usually only simulated.

In rarer cases, however, requalification during operation is necessary – accompanied by extremely high demands on coordination and safety by all parties involved.

At our customer POLYTECH Health & Aesthetics GmbH in Dieburg, we requalify several cleanrooms of GMP cleanliness classes C and D in this way every year. The reason: the manufacturer of high-quality silicone implants cannot shut down its ovens for the production of medical silicone gel at short notice.

If measurements are due to be carried out, they are subject to a detailed schedule that is binding for everyone involved. To ensure that measurement technicians and production staff do not get in each other’s way, especially in the sensitive vulcanization, mixing and texturing rooms, a high degree of responsibility and coordination skills are required on both sides (see photos!).

Published: August 2024