The facilities in Bergen auf Rügen are for sterile production of cytostatics, broths and pain pump production
The Sana Hospital Rügen commissioned the new cleanrooms within the Sana Hospital pharmacy for sterile production of cytostatics, broths and pain pumps. In what was a five-month project, WISAG Building and Industrial Services Central Germany designed, built and repurposed existing facilities into cleanrooms.
From this year, German pharmacies which prepare cytostatics and parenteral dosage forms have to meet new, higher cleanroom standards. The new mandatory rules amend the previous rules of procedure §35 ApBetrO. The stricter guidelines are particularly pertinent to the production of cytotoxic drugs where both patient safety and protection of healthcare personnel is paramount. Facilities producing cancer therapies must therefore satisfy the requirements of occupational safety as well as pharmaceutical standards.
WISAG has equipped the cleanrooms with a new air handling unit which cools or heats and dehumidifies air from outside and directs it via a filter system into the cleanroom and removes the old air. In addition, the company has installed a complex control system and provided autonomous monitoring through a new monitoring system.
'A particular challenge in this project was the low ceiling heights of the existing buildings. Just for the exhaust air handling and filter fan units we had to make special wall and ceiling designs. We also had to cut through walls and move lintels during normal hospital operations,' said Jörg Pohl, Project Manager at WISAG.
The Sana Hospital Pharmacy supplies more than 1,000 acute inpatient hospital beds in different locations.
The new cleanrooms are to be used to aseptically-prepare approximately 10,000 doses of tumour medications per year. In addition, the facility will produce pain pumps and nutrient solutions under sterile conditions.
In total, the Sana Hospital Rügen invested approximately €1.1m in the renovation.