Designing a 24/7 service cleanroom for personalised cancer treatment

The Cell & Gene Therapy department at the Norwegian Radium Hospital gave NNE a very specific task: Design a cleanroom for production of personalised treatments for cancer patients to run without interruption 24 hours a day, 7 days a week.

Providing treatment and medical products to patients at the right time and with the proper quality is crucial for ensuring patient safety, and is something all organisations that operate within the healthcare and life sciences industries aim for. Accordingly, organisations strive to preferably avoid or at least minimise operation shutdowns – especially in hospital cleanrooms, where patients are affected most.

In a pharmaceutical production facility, a shutdown of cleanroom operation often means loss of a batch and loss of money for the company. Another batch can be produced, and the end-user or patient will still get the product in time – although perhaps with a slight delay – and without comprise on quality. However, in the hospital world where treatment is often acute, sensitivity to cleanroom shutdown is extremely high.

When re-doing a batch is not an option

The Norwegian Radium Hospital, belonging to the Oslo University Hospital, is Norway’s dedicated centre for cancer treatment, and today the hospital is one of the leading cancer research and treatment centres in Northern Europe. The Cell & Gene Therapy (CGT) department produces unique treatments for each individual cancer patient. It harvests and prepares stem cells for blood and bone marrow for all patients receiving bone marrow transplants at the Oslo University Hospital. Its responsibilities include also translational and clinical research on cellular-based cancer vaccines that are tested in patients with malignant melanoma, glioblastoma, prostate cancer, lymphomas and ovarian cancer.

Because the patient’s own cells are used to produce the therapy, there is only one chance to get the treatment right. Thus, an unplanned cleanroom shutdown can compromise the blood product and, in the worst case, cost a patient’s life. Redoing "the batch" – as is done in many pharmaceutical companies – is simply not an option for the CGT department.

Consequently, NNE designed a cleanroom solution that runs without interruption 24 hours a day, 7 days a week. The cleanroom section includes areas with GMP class A, B,C, and D, and one of the cleanroom laboratories is furthermore designed for containment and biosafety level P2.

The total hospital project covers 20,000 m² with a total cost of EUR 215 million. NNE performed specialised design, design follow-up and site inspections for all cleanrooms and genetic therapy areas. We also provided services from basic design to handover in cooperation with Henning Larsen Architects.

Quick facts

Customer

Department of Cellular Therapy, Radiumhospitalet,
Oslo University Hospital

Country

Norway

Facility size

500 m2

Project duration

2009

Total investment cost

USD 3.8 million

Services provided

NNE performed specialised design, design follow-up and site inspections for all cleanrooms and genetic therapy areas