Norvegija – Registravimo sistemos ir tyrimo prietaisai – Invitation to Participate in Market Dialogue - Instruments for Sterility Testing St. Olavs hospital HF

Norvegija – Registravimo sistemos ir tyrimo prietaisai – Invitation to Participate in Market Dialogue - Instruments for Sterility Testing St. Olavs hospital HF

I dalis: Perkančioji organizacija

I.1) Pavadinimas ir adresai:

Oficialus pavadinimas: Sykehusinnkjøp HF
Adresas: Postboks 40
Miestas: VADSØ
Pašto kodas: 9811
Šalis: Norvegija
Asmuo ryšiams:
El-paštas: post@sykehusinnkjop.no
Interneto adresas (-ai):
Pagrindinis adresas: http://www.sykehusinnkjop.no

II dalis: Objektas

II.1.1) Pavadinimas:

Invitation to Participate in Market Dialogue - Instruments for Sterility Testing St. Olavs hospital HF
Nuorodos numeris: 2025/39231

II.1.2) Pagrindinis BVPŽ kodas:

33120000 Registravimo sistemos ir tyrimo prietaisai

II.1.3) Sutarties tipas:

Kita

II.1.4) Trumpas aprašymas:

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 sensitive information regarding technical devices and procedures or methods, or operational and business conditions that would be of competitive importance to keep secret, cf. procurement regulations § 7-4 and Section 13 of the Public Administration Act. Communication All communication throughout the process must be conducted via the Mercell portal at www.mercell.no. Any other form of communication with individuals involved in the decision-making process is not allowed, and inquiries made through other channels will not be answered. This ensures that all communication is properly documented. In the case of questions concerning all interested parties, the Client will answer this anonymously by providing the answer as additional information.

II.2) Aprašymas:

II.2.1) Kitas (-i) šio pirkimo BVPŽ kodas (-ai):

33120000 Registravimo sistemos ir tyrimo prietaisai