New clean rooms for Sana Hospital Pharmacy in Bergen on Rügen

The Sana Hospital Rügen GmbH has completely renovated and expanded a section of its central pharmacy for the sterilization of cytostatics, nutritional solutions, and pain pumps. (Source: WISAG Industrie Service)

The pharmacy team ensures that the individually manufactured medicines are available in impeccable quality to guarantee the best possible healing process for patients. (Source: WISAG Industrie Service)

Recently, Sana Hospital Rügen GmbH has installed new cleanrooms within the Sana Hospital Pharmacy for the sterilization of cytostatics, nutritional solutions, and pain pumps. Over a five-month project period, employees of WISAG Building and Industrial Services Central Germany GmbH & Co. KG reconfigured, extensively renovated, and constructed the cleanrooms.

Since this year, pharmacies that manufacture cytostatics and parenteral dosage forms are required to implement the highest standards for cleanrooms — as stipulated by the amended operational regulations (§ 35 ApBetrO). Strict guidelines particularly apply to the production of cytostatics. The manufacturing of medicines for cancer therapy must meet both occupational safety regulations and pharmaceutical standards. Ensuring safety for patients and protecting staff are top priorities here.

Therefore, WISAG employees equipped the cleanrooms with a new air handling system that conditions outside air. The system cools, humidifies or dehumidifies, or heats the air and introduces it into the cleanroom via filter supply outlets. Additionally, a complex control system and an autonomous monitoring system (monitoring system) were installed by WISAG specialists. "A particular challenge in this project was the low ceiling heights in the building of the former bed house. Especially for the laminar flow filter outlets and filter fan units, we had to create special constructions for walls and ceilings. Furthermore, walls had to be cut open and door frames installed and processed while the existing Sana hospital pharmacy remained operational," explains Jörg Pohl, the responsible project manager at WISAG.

The Sana Hospital Pharmacy supplies more than 1,000 acute-care hospital beds at various locations, including outside the island of Rügen, such as in the Hanseatic city of Stralsund. "The pharmacy team ensures that patient-specific medicines are available in perfect quality at the right place to guarantee the best possible healing process for our patients," says Silke Ritschel, Managing Director of Sana Hospital Rügen GmbH. The range includes everything from individual medication consultations to the custom manufacturing of preparations that are not available industrially.

In the new cleanrooms, approximately 10,000 doses of medication for tumor therapy are to be produced annually under aseptic conditions. Additionally, pain pumps and nutritional solutions are manufactured under sterile conditions. Overall, Sana Hospital Rügen GmbH invested around 1.1 million euros in the renovation, with the Ministry of Labour, Equality, and Social Affairs of Mecklenburg-Vorpommern contributing a funding notice of nearly 700,000 euros.

WISAG Building and Industrial Services is part of WISAG Industry Service, one of Germany’s leading industrial service providers. Its main focus is on planning, development, assembly, and maintenance of ventilation and air conditioning components and complex systems.