Utløpt Veiledende kunngjøring EU / TED Markedsdialog – ikke konkurranse

Norway – Recording systems and exploration devices – Invitation to Participate in Market Dialogue - Instruments for Sterility Testing St. Olavs hospital HF

Denne konkurransen er avsluttet. Det er 73 aktive anbud innen medisinsk utstyr nå.

Oppdragsgiver SYKEHUSINNKJØP HF

Publisert 25. februar 2025

Sammendrag fra kunngjøring og vedlegg (AI-generert)

Hva skal kjøpes inn?
St. Olav's Hospital HF skal anskaffe instrumenter for sterilitets testing. Dette er en del av forberedelsene til produksjon av 18F merkede radiopharmaceuticals som brukes i PET-skanning.

Sentrale krav til leverandør
- Ingen spesifikke krav nevnt i teksten.

Praktiske forhold
- Sykehusinnkjøp HF, avdeling Medisinskteknisk utstyr og laboratorieprodukter, Midt-Norge, handler på vegne av St. Olavs hospital HF.
- Det er estimert produksjon av ca. 400 batcher av 18F merkede radiopharmaceuticals per år.
- Alle batcher må testes for sterilitets for å sikre at de er fri for mikrobiologiske kontaminanter.

Tildelingskriterier
Ikke spesifisert i utdraget.

Generert fra kunngjøring og 0 vedlegg. Les originaldokumentene for autoritative krav.

Beskrivelse

St. Olav's Hospital HF is seeking to engage with potential suppliers through a market dialogue for the upcoming procurement of instruments for sterility testing (Reference: 2025/39231). This dialogue aims to gather valuable insights from the market to better define the requirements and ensure the selection of the best suited solution for our needs. We invite all interested parties to participate in this dialogue, which will help us refine our procurement strategy and ensure that the tender process is well-informed and aligned with current market capabilities. Client Sykehusinnkjøp HF was founded on 17 December 2015 and has a strategic and operational responsibility for procurement in the specialist healthcare service. The organisation has four owners: Helse Sør-Øst RHF, Helse Nord RHF, Helse Midt-Norge RHF and Helse Vest RHF, of which the ownership shares are 25 per cent each. The organisation will provide services exclusively to its owners, their fully owned entities, non-profit enterprises with operating agreements with regional health enterprises, and entities wholly owned or controlled by the Ministry of Health and Care Services that support the delivery of specialist healthcare services. In this procurement, Sykehusinnkjøp HF division Medisinskteknisk utstyr og laboratorieprodukter, Midt-Norge is acting on behalf of the following companies: • St. Olavs hospital HF (www.stolav.no) Scope of the procurement (tender overview) Radiopharmaceuticals are drugs that contain radioactive isotopes used in medical imaging for diagnostic purposes. 18F labelled radiopharmaceuticals produced at the PET center at St Olav hospital in Trondheim are sterile injectables administered in patients for PET scan (PET = positron emission tomography). St Olav hospital estimate production of about 400 batches of 18F labelled radiopharmaceuticals each year in the coming years. All batches must be tested for sterility to ensure that they are free from microbial contaminants. The radioactive isotope typically decays after a short time and due to their very short shelf life 18F radiopharmaceuticals are administered before they get tested. The test is currently carried out at an external lab which means results are available several weeks after administration. The samples are not radioactive when tested. The hospital is planning to invest in equipment/instrument for in-house sterility testing. Because of the product’s short shelf life, the rapid microbial methods are of great interest. As is the possibility to carry out bioburden test with the same instrument. Bioburden samples for routine checks include water samples after maintenance and/or cleaning. For specific projects bioburden of product samples are also tested. Manufacturing of radiopharmaceuticals must comply with European guidelines for Good Manufacturing Practice (GMP) and strict quality standards in the European Pharmacopoeia (Ph Eur). Qualification of instrument and method validation has to be performed for the center to meet regulatory requirements and approval by the national drug authorities. Costs of consumables and access to service/preventative maintenance is of importance. Input from stakeholders The client aims to gain an understanding of the current supplier market and available products/solutions, in order to better prepare a detailed user requirements specification. The market dialogue will be held as one-on-one meetings between the client and interested parties. A product presentation on existing solutions, as well as insights into planned product developments, is encouraged. Topics for Client Feedback: • Brief presentation of the stakeholder • Input for the acquisition: o Market delivery capacity (consumables, parts, support, and service) for the period covering the equipment's lifetime o Expected delivery time for equipment and materials, including installation o Primary validation o Budget o Reference sites o Suggestions regarding workstation solution and workflow o Minimum room size o Technical requirements, including weight, power, IT infrastructure, requirements for transportation, noise, etc. o Sustainable manufacturing practices and adherence to local and international environmental regulations (e.g. green certifications ISO 14001 for environmental management system) o Fair labor practices (prohibition of child and forced labor, safe working conditions, fair wages, workers' rights, and non-discrimination) o Any certification of the products and supplier Furthermore it could be valuable to learn about the interested party's experience with similar public tenders, particularly in comparable countries (ideally within the EU). Schedule: 06.03.25 Deadline registration 11.03.25 Meeting 1 hour Time allocated per session Place Teams Registration and questions Registration or questions for the market dialogue are made in the Mercell communication module. Confidentiality The client and its employees are obliged to prevent unauthorized access to or disclosure of s

Markedskontekst

Basert på 15 historiske tildelinger med CPV-kode som begynner på 3312, i samme fylke.

6 625 000 kr Typisk kontraktverdi (median)

1 152 500 kr – 140 000 000 kr Prisspenn (min – maks)

15 Ulike leverandører har vunnet i denne nisjen

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Bransjekoder (CPV)

33120000 - Registreringssystemer og undersøkelsesredskap

Geografi

Trøndelag

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Om denne anskaffelsen

Denne kunngjøringen ble publisert på TED (EU) 25. februar 2025 av SYKEHUSINNKJØP HF.

Tilbydere bør lese hele konkurransegrunnlaget nøye og merke seg kvalifikasjonskrav, tildelingskriterier og frister. Spørsmål til konkurransen rettes til oppdragsgiver.

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