Eurozyto, a German pharmaceutical manufacturer specialising in the provision of patient-specific infusion solutions has invested in two separately constructed cleanroom labs for the manufacture of parenteral nutrition and cytostatic medicines in Königstein. After a planning and construction phase spanning several months, the manufacture of medicines is now going into production.
The ready-to-use infusion solutions manufactured by Eurozyto are prepared in close co-operation with pharmacies, doctors and clinics, and the manufacturing process for the infusions is subject to a manufacturing permit pursuant to Section 13 of the German Pharmaceutical Law, which mandates use of GMP-compliant Class B cleanroom labs.
When producing toxic cytostatic solutions for cancer therapy, in addition to absolute sterility for patient safety, it is also necessary to protect employees from contamination while handling the toxic substances – even the transport of individual particles must be ruled out.
To ensure the best possible safety, Eurozyto installed two separate labs – cleanroom class GMP A in B. Pharmacist and MD 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.’
The company chose cleanroom specialist 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 pharmaceutical safety.
The new cleanroom labs at Eurozyto, together with their lock and work preparation chambers, comprise about 100m2 of cleanroom space. 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 with connected 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 Engineering, 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.
A special feature of the 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 demounted for possible expansions or reconfiguration.
The CleanSteriCell cleanroom labs were designed, built and ready for use within 16 weeks. Uwe-Bernd Rose was impressed by the construction, which was completed in record time: ‘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.’
