New hospital pharmacy with cytostatic production ensures patient care for the Sigmaringen district

The chemotherapy laboratory CleanSteriCell® achieves cleanroom class GMP A in B.

Safety cabinet for cytostatic production.

Modern hospital pharmacies are generally responsible for preparing individualized medicines for their patients. In particular, the production of cytostatics for cancer therapy demands the highest safety standards. To ensure patient care in the Sigmaringen district, the Sigmaringen clinics invested in the construction of a new pharmacy. The basement of the two-story pharmacy houses the sterile area, including 220 sqm of state-of-the-art cleanroom laboratories for the production of patient-specific cytostatic preparations.

New legal requirements for sterile rooms and a significant increase in the demand for cytostatics had pushed the old hospital pharmacy in Sigmaringen to the limits of its capacity. To continue providing comprehensive care for patients, the Sigmaringen district clinics decided on a new building for the pharmacy, which features a dedicated sterile area with GMP Class B cleanroom laboratories in the basement.

When manufacturing patient-specific cytostatic preparations for cancer therapy, it is essential to ensure not only maximum germ-free conditions to protect the patient but also comprehensive occupational safety. The process of producing sterile infusion solutions thus presents a major challenge to controlling workflows and maintaining room purity.

Dr. Werner Haussmann, who is responsible for the safety of operations as the head of the pharmacy, explains:

"In cancer therapy, cytostatic infusions are prepared individually for each patient. The medications must be available quickly to carry out therapy without long waiting times for the patients. We can ensure this through in-house production. During the preparation of infusions, germ-free conditions must be maintained to protect the patients, and the toxic solutions must not under any circumstances endanger pharmacy staff. Maximum personnel and product safety is our top priority in our new cleanroom laboratories."

The sterile area of the pharmacy was equipped with state-of-the-art technology and designed for the complex workflows involved in cytostatic production. The employed cleanroom system, CleanSteriCell®, is specifically developed for laboratories that must meet high GMP requirements. Multi-stage personnel and material sluice systems, operated with different pressure and air exchange rates, ensure the purity of the laboratory environment up to GMP Class B. Pharmacy staff must perform precisely prescribed clothing changes as well as cleaning and disinfection procedures before entering the cytostatic manufacturing area, Cleanroom Area B. There, cytostatic production takes place under safety cabinets of the highest cleanliness class, GMP A. Structured workflows and the use of the latest cleanroom technology ensure maximum drug and personnel safety.

Dr. Haussmann is very satisfied with the functionality of the laboratories after commissioning:

"The required complex cleanroom technology was supplied by Schilling Engineering, which has extensive experience in developing and installing sterile laboratories, especially cytostatic laboratories. The cleanroom laboratories were specifically designed to meet the spatial and functional requirements of our hospital pharmacy and meet all specifications without any issues. With this investment, we can significantly improve patient care in our clinics."

Integrated laminar flow units with ULPA high-performance filters ensure the supply of pure areas and workstations with clean air. The filtered air is introduced vertically at a uniform speed and displaces contaminated air over recirculation grilles from the clean environment. Through a method of recirculating cooled 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 is the wall connections, which are mounted using a patented silicone-free GMP sealing clip system. These connections are not subject to wear and can be easily dismantled for possible extensions or modifications.

For additional safety and clarity, the cleanroom control system CR Control® is used. The GMP-compliant control and monitoring system ensures seamless supervision and precise adjustment of the necessary cleanroom parameters. All functions of the cleanroom are operated, monitored, and regulated via a central touchscreen. Connected sensors measure pressure, humidity, and temperature of the individual cleanroom elements and record these for monitoring. The control system also checks the contamination level of all filters and displays maintenance recommendations. Malfunctions, such as a door not being properly closed, are indicated with an audible warning. Other components, such as lighting functions and climate modules, can also be operated individually.

The investment in high-quality and safe equipment enhances the competitiveness of the Sigmaringen clinics and secures their position as an oncology center for the district. The hospital pharmacy, including the cytostatic production, was put into operation at the beginning of 2014.