Purchase of a new VHP pass through decontamination chamber

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.Main features of the procedureThe procurement procedure is carried out as a negotiated procedure with the publication of a contract notice according to the Danish Public Procurement Act §§ 61-66 (Act no. 116/2025 of 3 February 2025) (hereafter the Public Procurement Act). The request to participate in the procurement procedure is done by submitting the European Single Procurement Document (hereafter “ESPD”). If the Contracting Authority receives more than 3 compliant applications, a selection will be made to find the 3 most suitable Candidates. The most suitable Candidates will be determined based on which Candidates that submit the most comparable and relevant references compared to the tendered project. In the selection, the Contracting Authority will assess each of the Candidates' up to 5 references based on the following methodology: 1. Experiences with test and installation of a VHP Chamber including cycle development for similar loads. • Limited comparability (VHP chamber for different Load Fractions) • Comparable (VHP chamber with Load Fractions 1 - 11) • High comparability (VHP chamber with Load Fraction 1 -11 and Load Fraction 12) 2. Experience with test and installation of a VHP Chamber in a barrier setting: • Limited comparability (e.g. standard cleanroom, non-biological containment) • Comparable (e.g. BSL-2, pharmaceutical production with special safety requirements) • High comparability (BSL-3 or BSL-4 biological containment) Criteria 1 will carry the most weight in the assessment. According to the above, the relevance of each reference will be concluded according to the following: very limited comparability, limited comparability, comparable, high comparability, very high comparability. The evaluation will overall be based on a total of 5 (five) references for each Candidate; however, the Contracting Authority will initially look upon the 2 (two) best references from each Candidate. If 2 (two) or more Candidates have achieved identical evaluations based on the best 2 (two) references the Contracting Authority will then focus on the quality and number of the remaining references. Please note that any ambiguities and/or incomprehensibilities in the information submitted under this section may be regarded negatively in the evaluation when selecting the limited numbers of candidates. The period for references has been extended from 3 years to 5 years due to the special delivery.