Public procurement notice: Voluntary Ex Ante Transparency Notice
Published: 2018-03-01
Buyer: Oslo universitetssykehus HF
Country: NO
Contract type: Supplies
Procedure: Contract award without prior publication
CPV classification: 33100000
Estimated value: 5800000 NOK

Technical requirements: The pharmacology department at Oslo University Hospital, Rikshospitalet, shall procure high capacity UHPLC-MS/MS equipment (CE-IVD certified), which shall be used for quantitative analyses of medicines, medicine metabolites and any bio-markers in biological sample material. The equipment must be able to analyse with two UHPLC channels simultaneously and it must be able to configure with at least 8 separation columns /analysis columns and 6-8 mobile phase systems. The equipment shall be used for monitoring medicine levels in patients and it must, therefore, be able to be used for analyses with very good operational stability, selectivity, sensitivity, precision and accuracy. The circulation time per sample on the instrument must be short and the capacity must be at least 25-30 000 samples per annum divided between at least 6 different analysis methods.
The pharmacology department at Oslo University Hospital, Rikshospitalet, shall procure high capacity UHPLC-MS/MS equipment (CE-IVD certified), which shall be used for quantitative analyses of medicines, medicine metabolites and any bio-markers in biological sample material. The equipment must be able to analyse with two UHPLC channels simultaneously and it must be able to configure with at least 8 separation columns /analysis columns and 6-8 mobile phase systems. The equipment shall be used for monitoring medicine levels in patients and it must, therefore, be able to be used for analyses with very good operational stability, selectivity, sensitivity, precision and accuracy. The circulation time per sample on the instrument must be short and the capacity must be at least 25-30 000 samples per annum divided between at least 6 different analysis methods. It is a prerequisite that there are quick changes (flexibility) between analysis methods. The system must, in principle, be operable every day year round (Monday-Sunday). It must have relative sensitive mass spectrometric detection in order to enable simple sample preparation and injection of relatively small biological material. All additional components that are necessary for the analysis equipment to be operative must be included in the procurement.
— The UHPLC-MSMS must be CE-IVD certified. The analyses require CE-IVD instrumentation in accordance with the EU Directive.
— Tenderers must have ready established and documented internal routines for CE-IVD that deal with documentation and reporting for all types of service visits, such as maintenance, repairs or breakdowns.
— The instrumentation must have room for at least 8 separation columns /analysis columns and valves that allow software-controlled choice of column.
— The sensitivity in the instrumentation must, as a minimum, be equivalent to S/N at 100 000:1 (1 pg reserpine on column, positive mode, unsmoothed).
— The UHPLC must be able to mix the mobile phase from different reservoirs, so that mobile phase gradient is allowed. The technical system must be binary high pressure mixture.
— The instrumentation must be efficient in its use of space. The maximum available space for the instrumentation, with the technical periphery equipment is (BxD: 160x125 cm).
— The technical periphery equipment must be efficient in its use of space. The available space in the technical rom for vacuum pumps and a nitrogen generator is (BxDxH: 125x90x150cm).
The high capcaity UHPLC-MS/MS equipment must be able to be used for quantitative analysis of medicines, medicine metabolites and any biomarkers in biological sample material. The equipment must be able to analyse with two UHPLC channels simultaneously and it must be able to configure with at least 8 separation columns/analysis columns and 6-8 mobile phase systems. The equipment shall be used for monitoring medicine levels in patients and it must, therefore, be able to be used for analyses with very good operational stability, selectivity, sensitivity, precision and accuracy. Short circulation time per sample on the instrument. The capacity must be minimum 25-30 000 samples per annum, divided between at least 6 different analysis methods. It is a prerequisite that there are quick changes (flexibility) between analysis methods. The system must be operable every day year round. It must have relative sensitive mass spectrometric detection in order to enable simple sample preparation and injection of relatively small biological material.
1— The UHPLC-MSMS must be CE-IVD certified. Our analyses require CE-IVD instrumentation in accordance with the EU directive.
2— Tenderers must have ready established and documented internal routines for CE-IVD, which deal with documentation and reports for all types of service visits, such as maintenance, repairs or break down.
3— The instrumentation must have room for at least 8 separation columns /analysis columns and valves that allow software-controlled choice of column.
4— The sensitivity in the instrumentation must, as a minimum, be equivalent to S/N at 100 000:1 (1 pg reserpine on column, positive mode, unsmoothed).
6— The UHPLC must be able to mix the mobile phase from different reservoirs, so that mobile phase gradient is allowed. The technical system must be binary high pressure mixture.


Winner: Waters
Award value: 5800000