Framework agreement for the hire and cleaning/laundry of cleaning equipment and clothing for GMP classified clean rooms for Oslo University Hospital

Description

Oslo University Hospital, c/o the Section for Cell Therapy and the Section for Ex Vivo Cell Laboratory (EVCL), invite tenderers to a contest for a framework agreement for the hire and cleaning/laundry of cleaning equipment and clothing for GMP classified clean room equipment for Oslo University Hospital. See annex 2 Requirements Specification and annex 1 Price Sheet for further details. Lot 1: The Section for Cell Therapy produces cell therapy products in accordance with the GMP rules. Hematopoetic stem cells are processed for allogeneous or autologous stem cell and bone marrow transplants, T-cell expansions, and cancer vaccines. The start material is human cells from blood or bone marrow from patients or healthy donors. The production is done in GMP classified clean rooms and there are strict requirements for aseptic work techniques. The protocols for vaccine production are approved by Statens legemiddelverk, whilst the remaining production is in accordance with the EU Directive Cell Regulations from the Ministry of Health and Care Services. The entity has also recently be JACIE accredited. The Ex Vivo Cell Laboratory (EVCL) is an aseptic production laboratory for cells that are used in patient treatment. The laboratory was established and certified as a clean room laboratory in 2001. EVCL is currently a section under the Immunology and Transfusion Medicine Department (IMM) at Oslo University Hospital, Rikshospital. Self-production is undertaken, as well as follow-up and implementation of external projects. The contracting authority would like to enter into a framework agreement with a tenderer for the hire and cleaning/laundry of cleaning equipment and clothing for GMP classified clean rooms for Oslo University Hospital.