Norway – Laboratory, optical and precision equipments (excl. glasses) – Automated test system for bacteriological monitoring of sample material from medical products to Helse Bergen HF

The contracting authority, Helse Bergen HF, intends to make a direct procurement of a Bact/Alert 3D Dual-T system from bioMérieux Norway AS based on the following reason: The contracting authority ́s opinion is that bioMérieux is the only actor on the market who can deliver a system that can be used for testing for sterility of both radiopharmaceutical and cell products with all the necessary functions and that fulfils all the requirements. The instrument shall be used for sterility inspections of products produced in ISO classified clean rooms. The justification for the direct procurement is that after a thorough professional evaluation the contracting authority has decided that the system provided by bioMérieux meets our requirements for this quality control analysis. The following is to be elaborated on: The system must be able to incubate bottles/tubes, inoculated with a test system, both at temperatures of 22.5 °C (between 20-25) and 32.5 °C (30-35), parallel. The system must automatically detect whether the growth has occurred in the bottles and notify about this. We know that only Bact/Alert 3D Dual-T can fulfil this requirement. As far as we know, it is the only system in the market that can control temperatures between 20 °C and 25 °C and also the possibility for temperature control for the entire temperature area between 30 °C and 35 °C. This function, with temperature control in both of these intervals, and the possibility to incubate at both temperatures in parallel, is possible in the system Bact/Alert 3D Dual-T, delivered by Biomerieux. The production of medicines shall be used in the treatment of patients in the clean rooms at the PET centre and the Ex-vivo facility. These advanced therapies must undergo strict quality control analyses before they can be released to patient use. There is, therefore, a high focus on the fact that all the instruments used for quality control analyses are as standardised as possible. The absolute minimum requirements for this procurement shall be as follows: Temperature monitoring of 22.5 °C (between 20-25) and 32.5 °C (30-35 ° C) with parallel bottles incubation shall be possible. There should be full traceability in the system and storage of completed activities for at least 10 years ("EU-GMP: the batch documentation must be kept for at least five years after the completion or formal discontinuation of the last clinical trial in which the batch was used.") It should be possible to have several privileges to the system for different types of users and administrators. The contracts will be signed without a prior tender notice, as according to what the contracting authority knows, there are no other suppliers who can fulfil the requirements in the market. Pursuant to procurements without a competition is the Public Procurement Regulations § 13-4 first section, letter b second point. An intention notice is published in accordance with the provision in § 21-5. Any enquiries about the intention of signing the contract shall be directed to Mathias Høydal Nilsen by 15.03.2025. Objections to the intention of signing the contract for the instrument shall be addressed to Sykehusinnkjøp, by consultant Mathias Høydal Nilsen inside Mercell.