Requalification of the cleanrooms requires a delicate touch

Cleanroom (Class B) with workbench (Class A), ©CAT Group

Preparation Room (Class C), ©CAT Group

In the hospital pharmacy: Sister Karin Johanna Haase (right, head of the pharmacy), Gabriele Anger (left, specialist pharmacist), ©CAT Group

In the foreground, the historic hospital building, on the left and in the background, the modern extensions, ©CAT Group

In the hospital pharmacy of Marienhospital Stuttgart, there is a calm bustle. Every move is precise, with no sign of haste. Over 1,200 different products – medications, pharmaceuticals, and medical supplies – pass through the hands of around 35 staff members here, are registered, assigned, sometimes prepared, and distributed to the hospital's wards and outpatient clinics. "The number of packaging units used here per week is in the high five figures," says Sister Karin Johanna Haase, who has been managing the hospital pharmacy for over 30 years.

Some of the medications are prepared directly in the pharmacy's cleanrooms into application-ready cytostatics. For the hospital with its large oncology department, this is an indispensable pillar of medical care that must function seamlessly at all times. Three pharmacists and six pharmaceutical technical assistants ensure that patients receive their individually tailored cancer medications (cytostatics) at the necessary time.

The requirements set by legislation and the German Society for Oncological Pharmacy for the processing of these medications in the cleanroom are high – and specific, as cytostatics are governed by their own standards and guidelines. "We have established a complex quality management system for our cytostatics department in the hospital pharmacy to flawlessly implement legal regulations. This is a highly sensitive area where we cannot afford the smallest mistake," emphasizes Sister Karin Johanna. "To ensure that daily operations run smoothly with so many involved, we continuously develop our quality assurance processes."

For many years, the CAT Clean Air Technology GmbH from Stuttgart has also been responsible for implementing GMP guidelines in the cleanrooms of the hospital pharmacy. The experienced measurement technology team requalifies the two cleanrooms (Class B), the workbenches (Class A), as well as the preparation room (Class C) and the airlocks at regular intervals. A particular challenge here is the extensive overall coordination and logistical effort. Even during the requalification measurements, which last two days per cleanroom, the pharmacy must ensure continuous production – without any disruptions. This is achieved by "moving" the preparation of cytostatics between the two technically and structurally identical cleanrooms during this period.

The Marienhospital also benefits from CAT's expertise in consulting, planning, and implementation. The latest example is the complete renovation of the two material transfer points between the preparation and manufacturing rooms.

However, the driving force behind the continuous development and high quality standards of the hospital pharmacy are, not least, Sister Karin Johanna and her dedicated team. The trained pharmacist came to Marienhospital in 1988 as part of her religious training – and has successfully managed the pharmacy and its cleanrooms in the basement of the historic Stuttgart hospital since 1991.