Intelligent wound care through temporary skin replacement

Intelligent wound care through temporary skin substitute

Polymedics Innovation invests in basic research and state-of-the-art cleanroom technology

The company Polymedics Innovation is dedicated to healing treatments for injuries to human skin. Current scientific findings and continuous research form the basis for the company's groundbreaking developments in the treatment of dermal wounds. For example, the innovative skin substitute material SUPRATHEL® is used for large-area burns and skin abrasions. The synthetic membrane, which mimics natural skin, adapts optimally to the wound surface and accelerates the healing process. The temporary skin substitute is applied only once to the wound and remains there until complete healing.

The manufacturing process of this thin, elastic membrane is subject to extremely high hygiene standards. To ensure a germ-free production of this sensitive product, Polymedics Innovation invests in the latest cleanroom technology. The production takes place in a specially developed cleanroom system for medical products, CleanMediCell®, which is designed to meet the cleanroom air quality of ISO Class D according to EU-GMP Annex. Since moisture could damage the sensitive material of the skin substitute, the cleanroom system is equipped with precision climate control that maintains constant temperature and humidity. The relative humidity is accurately kept at a level of 30%, ensuring unrestricted process safety.

The supply of pure air is based on the principle of turbulence-reducing displacement airflow, and the use of ULPA high-performance filters provides optimal clean air conditions in the production area. Process safety is further enhanced by a separate personnel and material lock. To prevent microbial transfer by staff, they enter the cleanroom via a personnel lock where they change into cleanroom-specific clothing. An interlocking control system locks all other doors of the lock group once one door is opened.

Adjacent to the lock entrance door, the SCHILLING CleanRoom ControlSystem CR Control® was integrated as a special feature of the cleanroom. This innovative control system manages connections to sensors measuring pressure, humidity, and temperature, as well as filter modules, climate cabinets, door and light functions, and other components. All critical functions are monitored and recorded, and are clearly displayed on the central touchscreen, from which they can be individually controlled and adjusted.

The technically demanding system was implemented by the specialized cleanroom technology company SCHILLING ENGINEERING GmbH. The cleanroom system, including planning, construction, and qualification, was completed in just three months and has since ensured flawless product safety.