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Clean room system for cytostatics production

New legal requirements for sterile rooms and a significant increase in the demand for cytostatics had brought the old hospital pharmacy in Sigmaringen to the limits of its production capacity. In order to continue to ensure complete patient care, the Kliniken Landkreis Sigmaringen, decided to build a new pharmacy, which has its own 220 m2 sterile area in the basement with GMP class B clean room laboratories.

In the production of cytostatic preparations, in addition to the greatest possible sterility for the protection of the patient, complete occupational safety must also be guaranteed. The production of sterile infusion solutions therefore poses a great challenge to the control of work processes and the cleanliness of the rooms. Dr Werner Haussmann, who as head of the pharmacy is responsible for the safety of the processes, explains: "In cancer therapy, cytostatic infusions are prepared individually for the respective patient. The drugs have to be available quickly so that the therapy can be carried out without long waiting times. We guarantee this through our in-house production. During the production of the infusions, not only must sterility be ensured to protect the patients, but the toxic solutions must not endanger the pharmacy staff under any circumstances. The highest level of personal and product protection therefore has top priority."

Equipment of the clean room system
The sterile area of the pharmacy was equipped with state-of-the-art technology and designed for the complex processes of cytostatics production. The CleanSteriCell cleanroom system used was specially developed for laboratories that have to meet the high GMP requirements. Multi-stage personnel and material lock systems, which are operated with different pressure and air changes, ensure the cleanliness of the laboratory facility up to GMP class B. The pharmacy employees must perform precisely prescribed changes of clothing as well as cleaning and disinfection procedures before entering the cytostatic laboratory's manufacturing room, clean room area B.

There, cytostatics production takes place under safety cabinets of the highest GMP A cleanliness class. The structured workflows and the use of state-of-the-art cleanroom technology ensure the highest level of safety for medicines and people. Dr Haussmann is very satisfied with the function of the laboratories after they were put into operation: "The cleanroom laboratories were designed by Schilling Engineering especially for the spatial and functional requirements of our hospital pharmacy and fulfil all specifications without any problems. With this investment, we can significantly improve patient care at our clinics." Flush laminar flow units with ULPA high-performance filters ensure the supply of clean air to the clean areas and workplaces. The filtered air flows in vertically at a uniform speed and displaces the polluted air from the clean environment via recirculation grilles.

Thanks to a method of recirculating the conditioned air developed by Schilling Engineering, the system can be operated more energy-efficiently and thus more cost-effectively than comparable systems. A special feature of the system are the wall connections, which are mounted by means of a patented silicone-free GMP sealing clip system. These connections are not subject to any wear process and can be easily dismantled for possible extensions or conversions. The CR-Control® cleanroom control system provides additional safety and clarity. The GMP-compliant monitoring and control system enables seamless monitoring and precise coordination of the required cleanroom parameters.

All cleanroom functions are controlled, monitored and, if necessary, regulated via a central touch screen. Pressure, humidity and temperature of the individual cleanroom elements are measured via connected sensors and recorded for monitoring. The control system also checks the degree of contamination of all filters and displays maintenance recommendations. Malfunctions, such as a door that is not closed properly, are indicated by a warning tone. Other components such as lighting functions and air-conditioning modules can also be controlled individually.

This article was published: Pharmaproduktion 1_2015

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