Mannheim Universitätsklinikum consists of 30 clinics and covers the full spectrum of care areas and special clinics University clinic is owned by the city of Mannheim and it serves the metropolitan area in the Rhein-Neckar-triangle. The main emphasis of GMP are amongst others the requirements for hygiene, the facilities, the equipment andcertainly the air quality.
Challenge
The clinical Radiopharmacy department of the Clinical Radiology and Nuclear Medicine Institute of the university clinic Mannheim needed to reduce the number of particles in the production process.
The institute wanted to follow Good Manufacturing Practice (GMP) guidelines for radiopharmaceuticals according to the German and international guidelines to improve air quality in a special manufacturing sector.
The amount of particles in the size range between 0,5μm and 5,0 μm is relevant for the GMP-section.
Solution
The head of of Radiopharmacy department Prof. Dr. Björn Wängler decided to install a Genano 5250 device in the laboratory.
In using the Genano air decontamination device 5250 a significant lower deviation of the GMP limits was achieved.
“We achieved much better results than we had to achieve following GMP.” – Prof. Björn Wängler
Result
After running a detailed test pattern the customer was extremely satisfied with the results.
ISO class 7 was achieved with < 350.000 particles 0,5 μm/ m3 in the specific test room. This result was even better than the requirements of the provincial health office. The mobile air decontamination unit was also easy to take into other departments to improve the Indoor Air Quality wherever needed.
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