Eurozyto GmbH investing in 200 square metres of cleanroom laboratories

Cleanroom laboratory for parenteral nutrition. CleanSteriCell® GMP A in B with laminar flow workbenches.

Cleanroom laboratory for cytostatics. CleanSteriCell® GMP A in B with safety workbenches.

Eurozyto GmbH is a specialist in the provision of patient-specific infusion solutions. The pharmaceutical manufacturer from Königstein has invested in two separately constructed cleanroom labs for the manufacture of parenteral nutrition and cytostatic medicines. After a planning and construction phase spanning several months, the manufacture of medicines is now going into production.  

Ready-to-use infusion solutions manufactured by Eurozyto GmbH are prepared in close cooperation with pharmacies, doctors and clinics. The service provider from Königstein has made it their goal to ensure the supply of patients individually, quickly and at top quality. The manufacturing process for the infusions is subject to a manufacturing permit pursuant to Section 13 of the German Pharmaceutical Law. Among other things, this mandates the use of GMP-compliant Class B cleanroom laboratories. In the production of toxic cytostatic solutions for cancer therapy, in addition to absolute sterility for patient safety, it is also necessary to guarantee absolutely gap-free workplace safety. Employees must be protected from any contamination while handling these toxic substances – even the transport of individual particles must be ruled out.  The manufacturing process for parenteral infusion solutions thus represents a significant challenge in work process control and cleanliness of the rooms.

To ensure the best possible safety, Eurozyto GmbH installed two separate laboratories in cleanroom class GMP A in B. Pharmacist and managing director Uwe-Bernd Rose explains: "We want to achieve the best possible quality and safety standards, so we made no compromises when investing in the technical equipment for the laboratories. By separating manufacturing into toxic and non-toxic areas, we rule out any cross-contamination. We looked for an expert in construction of cleanroom technology who had experience in the manufacturing of cleanroom laboratories and could guarantee functional and especially consistently safe processes." 

They decided on cleanroom specialists SCHILLING ENGINEERING. This company in Baden-Württemberg offers their own cleanroom system CleanSteriCell®, a cleanroom technology specifically developed for laboratories that meets all GMP requirements and ensures the best possible pharmaceutical safety.

The new cleanroom laboratories at Eurozyto GmbH, together with their lock and work preparation chambers, are about 100 square metres of cleanroom space. Each laboratory 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 with connected work preparation rooms increases the cleanroom class to GMP B using falling pressure differentials and increased rates of air exchange. Cytostatic workbenches ensure absolute germ-free conditions and unlimited personnel safety during the process of manufacturing cancer drugs. The second cleanroom laboratory, for parenteral nutrition, is equipped with laminar flow workbenches. Flush-mounted laminar flow units with high-performance 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 ENGINEERING for use with air-conditioned air allows the system to be operated more energy-efficiently than comparable systems. A GMP-compliant monitoring system ensures continuous control and precise calibration of the required cleanroom parameters. One special feature of the innovative cleanroom system is the wall connectors, which are mounted using a silicone-free GMP sealing clip system. The connections are not subject to any wear and can be dismounted for possible expansions or reconfiguration.

The CleanSteriCell® cleanroom laboratories were designed, built and ready for use within 16 weeks. Uwe-Bernd Rose was impressed by the construction of the cleanroom systems: "The cleanroom technology was built in record time. The work of the service technicians from SCHILLING ENGINEERING was truly impressive. They're fast, communicative and know what they're doing. We are looking forward to future tasks and are sure that our cleanroom laboratories will make a significant contribution to the safe care of patients in our community."