TED846489-2025
Purchase of a new VHP pass through decontamination chamber
- Ordregiver
- Statens Serum Institut
- Oplyst værdi / estimat
- 4.500.000 DKK
- Frist
- —
- Publiceret
- 19.12.2025
- Leveringssted (NUTS)
- DK011, DNK
Dataposten opdateret . Datakilder, dækning og beregningsmetode.
Beskrivelse
This procurement procedure concerns the award of a Contract regarding the purchase and installation of a VHP pass through decontamination chamber at Statens Serum Institute, Denmark (hereafter noted as SSI). The specification of requirements is found in Appendices 2, 2.1 – 2.6. - SSI conducts research in infectious diseases by in vivo testing primarily in rodents, requiring containment measures for biosafety level (BSL) 3 and “Genetically Modified Organism” GMO class 1-2. In accordance with local and international guidelines on biosafety containment, materials and equipment for reuse, and contaminated waste, must be decontaminated before removal from the building. - In this dedicated building (hereafter noted as BXX), o contaminated waste and reusable non-heat sensitive items from the BSL 3 area, are decontaminated via a pass-through autoclave using saturated steam before removal. o surface decontamination of reusable heat sensitive items from BSL 3 is via an airtight pass-through chamber using VHP as a decontaminant before removal. - The current chamber in the dedicated building which is in use for the surface VHP decontamination of different heat sensitive loads shall be replaced with a new VHP pass-through decontamination chamber inclusive of all supporting units/system/VHP generator. - After decontamination of the BSL3 area where the VHP-chamber is located, SSI will establish an airtight dust wall, allowing for installation and testing of the new VHP-unit in a declassified area. Furthermore, SSI will ensure removal and disposal of the current VHP-chamber in its entirety and including the current rack system. - The Vendor shall ensure transportation of the VHP chamber to the allocated place, and after installation confirm that the replacement VHP pass-through decontamination chamber has maintained airtightness. - The airtight VHP decontamination chamber will be sealed by SSI to the structural opening in the Arcoplast® with an FDA approved silicon (joint compound) to achieve an airtight barrier around the VHP decontamination chamber between the BSL3 and BSL2 areas. See Appendix 2, page 2. - A project plan for manufacture, Factory Acceptance Test (FAT), transportation, installation, sealing, airtightness control, Site Acceptance Test (SAT), test procedures (Installation Qualification (IQ) and Operational Qualification (OQ) and cycle development shall be included in the Offer. Sealing and airtightness control shall be included in the project plan even though it will be implemented by SSI. - Please see Appendix 2 for specification of Load Fractions and be aware of the possibility to submit Parallel Offers, cf. Tender Conditions section 5.4 with and without Load Fraction 13.
Procedure og udbudsmateriale
Oplysninger fra bekendtgørelsen kan dække flere delkontrakter. Listerne nedenfor er separate uddrag; rækkefølgen kobler ikke et kriterium til en beskrivelse eller delkontrakt. Kontrollér krav, vægtning, frister, optioner og eventuelle rettelser i originalmaterialet.
Proceduretype (kildens kode)
- neg-w-call
Tildelingskriterier
- Price
- Assurance of Quality
- Solution – Loads and programs
- Schedule and reliability
Beskrivelser af tildelingskriterier
- See the Tender Conditions, section 8.1 for an overview of requirements and the weight of these, and Appendix 5 for a detailed description of the elements that weigh positively in the evaluation. The requirements in Appendix 4 are detailed described in Appendix 2.
- See the Tender Conditions, section 8.1 for an overview of requirements and the weight of these, and Appendix 4 for a detailed description of the elements that weigh positively in the evaluation. The requirements in Appendix 4 are detailed described in Appendix 2.
Beskrivelser af krav til deltagelse
- The Candidate must submit information on the Candidate’s annual turnover for the last 3 (three) financial years. The information shall be stated in the European Single Procurement Document (ESPD), Part IV.B “General yearly turnover”. In the event the Contracting Authority requires documentation for the above the Candidate must provide the 3 (three) latest audited annual financial reports. If these are not in English or Scandinavian, the Candidate is asked to also provide a resume in English. Reference is made to section 4.4 in the Tender Conditions with regard to the Candidates' possibility of relying on the capacity of other entities. Minimum levels required: The Candidate must have achieved an annual turnover of at least EUR 1 000 000 in each of the preceding 3 (three) financial years. If the turnover is not stated in said currency, the Contracting Authority will calculate the turnover based on the official exchange rate on the date for receipt of requests to participate.
- The Candidates must provide the following in the European Single Procurement Document (ESPD) section IV.C: A description of the 5 (five) most important similar references of deliveries, cf. section 2.1. The specific phases must have been completed and accepted within the last 5 (five) years prior to the deadline for the request to participate. More than 5 (five) references will not be taken into account. Each reference of deliveries should preferably include the following information: — a description of the specific chamber, incl. load fractions — a description of the relevant classification/environment/barrier setting — information on the Candidate’s role and responsibility in the delivery — information on the Contracting Authority — information on when the project was carried out (start and date of handover - if it has ended), — information on the estimated contract sum (if possible), The description should include a clear indication of which specific part of the reference that is similar to the deliveries described in Appendix 2, including the Candidates' participation/role in the performance of the reference. Only references performed at the time of the deadline for the request to participate will be considered when assessing which Candidates have documented the most relevant previous references. If the reference is ongoing, it is only the part of the works carried out within the past 5 (five) years and completed at the time of the deadline for the request to participate that will be included in the assessment of the references. Consequently, if a part of the reference has not been carried out within the past 5 (five) years, or if a part of the reference has not been completed at the time of the deadline for the request to participate, this particular part of the reference will not be included in the assessment of the reference. The period has been extended from 3 years to 5 years due to the special delivery. Reference is made to section 4.4 in the Tender Conditions with regard to the Candidate's possibility of relying on the capacity of other entities. Minimum level(s) of standards possibly required: The Candidate must with a minimum of 2 (two) references demonstrate experience within the last 5 (five) years with a delivery of a VHP chamber in a clean room or equivalent, including the following phases: Design, Production, Factory acceptance test, Transport, Installation, Site acceptance test, Cycle development, Complete documentation and User training. The Candidate must have had the overall responsibility for the execution of the delivery; however, specific elements may have been performed by a subcontractor, e.g. transport. In ESPD Part IV “Selection criteria”, the Candidate must state how the minimum requirements for meeting the criteria are fulfilled. If the Candidate chooses to attach its references, this must be indicated in section C of the ESPD, and the selected references must be attached. A maximum of 5 references may be provided. Any additional references, whether listed or attached, will not be assessed.
Oplyste optioner
- The Customer has the option to buy different levels of service, cf. Contract section 11. The service agreement and options offered by the Vendor can be adopted at any point the Customer desires, though this is limited to 6 months after the expiry of the Warranty period.
Udbudsmateriale
Aflevering af tilbud
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