In the production of cytostatic preparations, complete occupational safety must be guaranteed in addition to the greatest possible sterility to protect the patient. The production of sterile infusion solutions therefore poses a major challenge in terms of controlling 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 each patient. The medication must be available quickly so that the therapy can be carried out without long waiting times. We guarantee this through our in-house production. When preparing the infusions, not only must sterility be ensured to protect patients, but the toxic solutions must not endanger pharmacy staff under any circumstances. The highest level of personal and product protection is therefore our top priority.”
Equipment of the cleanroom system
The sterile area of the pharmacy was equipped with state-of-the-art technology and designed for the complex processes of cytostatic production. The CleanSteriCell cleanroom system used has been specially developed for laboratories that have to meet the high GMP requirements. Multi-stage personnel and material airlock systems, which are operated with different pressure and air exchange rates, guarantee the cleanliness of the laboratory system up to GMP class B. Pharmacy employees must carry out precisely prescribed changes of clothing as well as cleaning and disinfection procedures before entering the cytostatic laboratory’s production room, cleanroom area B.
Cytostatic production takes place there under safety cabinets of the highest GMP A cleanliness class. The structured work processes and the use of the latest cleanroom technology ensure maximum drug and personal safety. Dr. Haussmann is very satisfied with the function of the laboratories after commissioning: “The clean room laboratories were specially designed by Schilling Engineering for the spatial and functional requirements of our hospital pharmacy and meet all specifications without any problems. This investment will enable us to significantly improve patient care in our clinics.” Flush-mounted laminar flow units with ULPA high-performance filters ensure that the clean areas and workstations are supplied with ultra-pure air. 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 process developed by Schilling Engineering for recirculating the conditioned air, the system can be operated more energy-efficiently and therefore more cost-effectively than comparable systems. A special feature of the system is the wall connections, which are mounted using a patented silicone-free GMP sealing clip system. These connections are not subject to wear and tear 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 adjustment of the required cleanroom parameters.
All cleanroom functions are controlled, monitored and, if necessary, regulated via a central touchscreen. The pressure, humidity and temperature of the individual cleanroom elements are measured via connected sensors and recorded for monitoring purposes. 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
