If every move has to be perfect

Since the ovens for the production of medical silicone gel cannot be shut down at short notice, the requalification measurements are carried out at POLYTECH during ongoing operation.

Requalification measurements in cleanrooms are a sensitive matter. For this reason, production or operation in these rooms is usually suspended during the measurement activities. If "in operation" measurements are desired, the processes (for example, the manufacture of pharmaceuticals or technical components such as semiconductors) are mostly simulated. In rarer cases, requalification during ongoing operation is necessary — accompanied by extremely high demands on coordination and safety from all involved parties.

At POLYTECH Health & Aesthetics GmbH in Dieburg, several cleanrooms of GMP cleanliness classes C and D are requalified in this manner every year. The company is one of the internationally leading manufacturers of high-quality silicone implants; all products are exclusively developed at the company's headquarters in Germany and manufactured under cleanroom conditions. When measurements are taken, they are carried out according to a detailed schedule that is binding for all parties involved. "Every single implant we produce undergoes multiple quality controls during the manufacturing process," says Paul Mooney, Head of Global Marketing at POLYTECH. "The demanding standards we must meet daily are crucial for our success and enable us to supply our products to surgeons and patients worldwide. We demand and expect top performance."

For the requalification measurements at POLYTECH, CAT Clean Air Technology GmbH from Stuttgart has been responsible for ten years now. The range of services includes, among others, filter leak tests, the determination of parameters such as air cleanliness class, recovery time, room pressure, and temperature/humidity, calibration of pressure sensors, as well as microbiological measurements (air microbial count). To prevent technicians and production staff from hindering each other, especially in the sensitive vulcanization, mixing, and texturing rooms, a high level of responsibility and coordination skills are required on both sides.

"We highly value the long-term partnership with CAT. They have taken the time to get to know POLYTECH and our unique processes," says Paul Mooney.

Implants from POLYTECH are used in reconstructive and plastic aesthetic surgery. The company, founded in 1986, is the only German manufacturer of soft tissue implants; its products are distributed worldwide in 80 countries. These include, alongside breast implants, also breast and tissue expanders for reconstruction, as well as body contouring implants for the face, breast, and calf regions. All implants are filled with a highly cross-linked, cohesive silicone gel and available with various surface textures to meet the individual needs of surgeons and patients worldwide.