Eurozyto GmbH invests in 200 sqm 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 cabinets

Eurozyto GmbH specializes in providing patient-specific infusion solutions. The pharmaceutical manufacturer has invested in two separate cleanroom laboratories for the production of parenteral nutrition and cytostatics. After several months of planning and setup, the production of the medicines is now underway.

The infusion solutions manufactured by Eurozyto GmbH are ready-to-use and produced in close collaboration with pharmacies, doctors, and clinics. The service provider from Königstein aims to ensure the supply of sick patients in a personalized, timely, and high-quality manner. The manufacturing process of the infusions is subject to manufacturing authorization according to § 13 of the Medicines Act. This requires, among other things, the use of GMP-compliant cleanroom laboratories of class B. When producing toxic cytostatic solutions for cancer therapy, absolute germ freedom must be maintained to protect the patient, and an impeccable occupational safety must also be guaranteed. Employees handling toxic substances must be protected from any contamination, and the spread of individual particles must be prevented. The manufacturing process of parenteral infusion solutions thus poses a significant challenge to controlling workflows and maintaining room purity. To ensure the highest safety standards, Eurozyto GmbH has installed two separate GMP A cleanroom laboratories. Pharmacist and Managing Director Uwe-Bernd Rose explains:

"We want to achieve the highest quality and safety standards and have made no compromises in investing in the technical equipment of the laboratories. By separating the production into toxic and non-toxic areas, cross-contamination is excluded. For the installation of the cleanroom technology, we sought an expert with experience in manufacturing cleanroom laboratories who could guarantee a functional and, above all, consistently safe process."

The choice fell on the cleanroom specialist SCHILLING ENGINEERING. The Baden-Württemberg-based company offers the specially developed cleanroom system CleanSteriCell®, which is tailored for laboratories, meets all GMP requirements, and ensures the highest drug safety.

The new cleanroom laboratories of Eurozyto GmbH each feature about 100 sqm of cleanroom space with lock and work preparation rooms. Each laboratory is accessed via a multi-stage personnel and material lock system, which ensures structured workflows and additional safety. In three sequential personnel lock chambers with connected work preparation rooms, the cleanroom class is increased to GMP B through decreasing pressure differentials and increased air exchange rates. Cytostatic cabinets ensure absolute germ freedom and unrestricted personnel protection during the production of cancer drugs. The second cleanroom for parenteral nutrition is equipped with laminar flow workbenches. Surface-integrated laminar flow units with ULPA high-performance filters ensure the supply of the sterile areas and workstations with pure air based on the turbulence-free displacement principle. The recirculation and exhaust air systems are integrated into the cleanroom walls. An energy-efficient operation of the system is achieved through a recirculation method developed by SCHILLING ENGINEERING for conditioned air. A GMP-compliant monitoring system ensures seamless control and precise adjustment of the required cleanroom parameters. A special feature of the innovative cleanroom system is the wall connections, which are mounted with a silicone-free GMP sealing clip system. These connections are wear-resistant and can be easily dismantled for possible extensions or modifications.

The CleanSteriCell® cleanroom laboratories were designed, constructed, and commissioned within 16 weeks. Uwe-Bernd Rose expresses his admiration for the setup of the cleanroom systems:

"The cleanroom technology was installed in record time. The work of SCHILLING ENGINEERING's service technicians was truly remarkable. They are quick, communicative, and knowledgeable about what they do. We are now looking forward to future tasks and are confident that our cleanroom laboratories will contribute to the safe supply of patients in our region."