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.