Public procurement notice: Prior Information Notice Without Call For Competition
Published: 2025-02-25
Buyer: Sykehusinnkjøp HF
Country: NO
Region: NO074
Contract type: Supplies
CPV classification: 33120000: Physiological monitoring systems
Submission deadline: 2025-03-24

Technical requirements: 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.