Germany-based Eurozyto, which specialises in the provision of patient-specific infusion solutions, has invested in 100m2 of new cleanroom space for the manufacture of parenteral nutrition and cytostatic medicines in Königstein.
The ready-to-use infusion solutions produced by Eurozyto are prepared in close co-operation with pharmacies, doctors and clinics, and the production process for the infusions requires use of GMP-compliant Class B cleanroom labs.
To ensure the best possible safety, Eurozyto had two separate labs installed – cleanroom class GMP A in B. For the construction, Eurozyto chose specialist company Schilling Engineering in Baden-Württemberg, which offers its own CleanSteriCell cleanroom system specifically developed for labs. The system meets all GMP requirements and ensures the best possible safety.
Each lab is reached through a multi-level personnel and material lock system that ensures structured work processes and additional safety. Three personnel locks arranged one after the other (and connected to work preparation rooms) increase the cleanroom class to GMP B using falling pressure differentials and increased rates of air exchange.
Cytostatic workbenches ensure germ-free conditions and personnel safety during the manufacture of cancer drugs. The second cleanroom lab, for parenteral nutrition, is equipped with laminar flow workbenches.
Flush-mounted laminar flow units with high-performance ultra low penetrating air (ULPA) filters supply the clean areas and working areas with ultra-clean air using a low-turbulence laminar flow system. The circulation and air return is integrated into the walls of the cleanrooms. An air circulation process developed by Schilling, for use with pre-conditioned air, allows the system to be operated with greater energy efficiency than comparable systems.
A GMP-compliant monitoring system ensures continuous control and precise calibration of the required cleanroom parameters.
Special wall connectors, mounted using a silicone-free GMP sealing clip system, are not subject to wear and can be demounted for future expansion or reconfiguration.
