Fakta om udbudet

EU-nr

Offentliggjort

19.12.2025

Udbudstype

Andre

Bestilling af materiale

https://eu.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=445496&TID=406755&B=

Udbyder

Statens Serum Institut

Purchase of a new VHP pass through decontamination chamber

Statens Serum Institut

1. Buyer

1.1.

Buyer

Official name : Statens Serum Institut

Email : maria.matzen@twobirds.com

Legal type of the buyer : Body governed by public law

Activity of the contracting authority : Health

2. Procedure

2.1.

Procedure

Title : Purchase of a new VHP pass through decontamination chamber

Description : 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 identifier : 5959d75f-c861-436e-b7f1-cb13ea447d51

Internal identifier : #01

Type of procedure : Negotiated with prior publication of a call for competition / competitive with negotiation

The procedure is accelerated : no

Main features of the procedure : The 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.

2.1.1.

Purpose

Main nature of the contract : Supplies

Additional nature of the contract : Services

Main classification ( cpv ): 38000000 Laboratory, optical and precision equipments (excl. glasses)

Additional classification ( cpv ): 33910000 Pathology dissection instruments and supplies, 38543000 Gas-detection equipment, 42123100 Gas compressors, 42514200 Electrostatic air and gas cleaners

2.1.2.

Place of performance

Country subdivision (NUTS) : Byen København ( DK011 )

Country : Denmark

2.1.3.

Value

Estimated value excluding VAT : 4 500 000,00 DKK

2.1.4.

General information

Additional information : To use the tendering system, the Candidate must create a user account. The Candidate can obtain a username and password via the tendering website. If the Candidate encounters technical problems when using the tendering system, they can contact the tendering system's technical support by email: dksupport@eu-supply.com or by telephone: +45 70 27 61 70. - Exclusion grounds: Only the mandatory grounds for exclusion in Sections 135 and 136 of the Public Procurement Act apply in connection with this tender. Please refer to the provisions of the Public Procurement Act for the final and complete wording of the aforementioned provisions. - Documentation: The Candidate must complete and submit the ESPD as preliminary evidence of the circumstances referred to in Section 148(1)(1)-(3) of the Public Procurement Act. Before a decision is made on the award of the contract, documentation for the information provided in the ESPD must be submitted, cf. Sections 151 and 152 of the Public Procurement Act. A Candidate who is subject to a ground for exclusion is excluded from participating in the tender unless the Candidate has provided sufficient documentation to prove that they are reliable in accordance with Section 138 of the Public Procurement Act. The Contracting Authority may only exclude a Candidate if the Contracting Authority has notified the Candidate that it is subject to a ground for exclusion and if the Candidate has not, within a reasonable period of time, provided sufficient documentation of its reliability (self-cleaning). With regard to what constitutes sufficient documentation, reference is made to section 138(3) of the Public Procurement Act. As documentation that the Candidate is not covered by one of the grounds for exclusion in section 135(1) and (3), the following must be submitted, cf. section 153 of the Public Procurement Act: An extract from a relevant register or equivalent document showing that the Candidate is not covered by Section 135(1), and a certificate proving that the Candidate is not covered by Section 135(3). If the country in question does not issue these types of documentation or if they do not cover all the cases in Section 135(1) or (3), they may be replaced by a sworn statement or a declaration on honour made before a competent judicial authority, etc., if sworn statements are not used in the country in question. For Danish Candidates, the proof may consist of a service certificate (max. 6 months old). If the tenderer, one or more of the participants in the association or other entities are from another EU/EEA country, they must as a rule submit the types of documentation specified in e-Certis. - Offers submitted after the deadline will not be considered. - Further details and conditions for submitting Offers are set out in the Tender Conditions attached to the procurement documentation.

Legal basis :

Directive 2014/24/EU

2.1.6.

Grounds for exclusion

Sources of grounds for exclusion : European Single Procurement Document (ESPD) , Notice

Corruption : Has the economic operator itself or any person who is a member of its administrative, management or supervisory body or has powers of representation, decision or control therein been the subject of a conviction by final judgment for corruption, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable? As defined in Article 3 of the Convention on the fight against corruption involving officials of the European Communities or officials of Member States of the European Union, OJ C 195, 25.6.1997, p. 1, and in Article 2(1) of Council Framework Decision 2003/568/JHA of 22 July 2003 on combating corruption in the private sector (OJ L 192, 31.7.2003, p. 54). This exclusion ground also includes corruption as defined in the national law of the Contracting Authority (contracting entity) or the economic operator

Fraud : Has the economic operator itself or any person who is a member of its administrative, management or supervisory body or has powers of representation, decision or control therein been the subject of a conviction by final judgment for fraud, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable? Within the meaning of Article 1 of the Convention on the protection of the European Communities' financial interests (OJ C 316, 27.11.1995, p. 48).

Money laundering or terrorist financing : Has the economic operator itself or any person who is a member of its administrative, management or supervisory body or has powers of representation, decision or control therein been the subject of a conviction by final judgment for money laundering or terrorist financing, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable? As defined in Article 1 of Directive 2005/60/EC of the European Parliament and of the Council of 26 October 2005 on the prevention of the use of the financial system for the purpose of money laundering and terrorist financing (OJ L 309, 25.11.2005, p. 15).

Participation in a criminal organisation : Has the economic operator itself or any person who is a member of its administrative, management or supervisory body or has powers of representation, decision or control therein been the subject of a conviction by final judgment for participation in a criminal organisation, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable? As defined in Article 2 of Council Framework Decision 2008/841/JHA of 24 October 2008 on the fight against organised crime (OJ L 300, 11.11.2008, p. 42).

Terrorist offences or offences linked to terrorist activities : Has the economic operator itself or any person who is a member of its administrative, management or supervisory body or has powers of representation, decision or control therein been the subject of a conviction by final judgment for terrorist offences or offences linked to terrorist activities, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable? As defined in Articles 1 and 3 of Council Framework Decision of 13 June 2002 on combating terrorism (OJ L 164, 22.6.2002, p. 3). This exclusion ground also includes inciting or aiding or abetting or attempting to commit an offence, as referred to in Article 4 of that Framework Decision.

Child labour and including other forms of trafficking in human beings : Has the economic operator itself or any person who is a member of its administrative, management or supervisory body or has powers of representation, decision or control therein been the subject of a conviction by final judgment for child labour and other forms of trafficking in human beings, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable? As defined in Article 2 of Directive 2011/36/EU of the European Parliament and of the Council of 5 April 2011 on preventing and combating trafficking in human beings and protecting its victims, and replacing Council Framework Decision 2002/629/JHA (OJ L 101, 15.4.2011, p. 1).

Grave professional misconduct : Is the economic operator guilty of grave professional misconduct? Where applicable, see definitions in national law, the relevant notice or the procurement documents.

Misrepresentation, withheld information, unable to provide required documents and obtained confidential information of this procedure : Can the economic operator confirm that: a) It has been guilty of serious misrepresentation in supplying the information required for the verification of the absence of grounds for exclusion or the fulfilment of the selection criteria, b) It has withheld such information, c) It has not been able, without delay, to submit the supporting documents required by a contracting authority or contracting entity, and d) It has undertaken to unduly influence the decision making process of the Contracting Authority or contracting entity, to obtain confidential information that may confer upon it undue advantages in the procurement procedure or to negligently provide misleading information that may have a material influence on decisions concerning exclusion, selection or award?

Conflict of interest due to its participation in the procurement procedure : Is the economic operator aware of any conflict of interest, as indicated in national law, the relevant notice or the procurement documents due to its participation in the procurement procedure?

Direct or indirect involvement in the preparation of this procurement procedure : Has the economic operator or an undertaking related to it advised the Contracting Authority or contracting entity or otherwise been involved in the preparation of the procurement procedure?

Breaching obligation relating to payment of social security contributions : Has the economic operator breached its obligations relating to the payment social security contributions, both in the country in which it is established and in Member State of the Contracting Authority or contracting entity if other than the country of establishment?

Breaching obligation relating to payment of taxes : Has the economic operator breached its obligations relating to the payment of taxes, both in the country in which it is established and in Member State of the Contracting Authority or contracting entity if other than the country of establishment?

5. Lot

5.1.

Lot : LOT-0000

Title : Purchase of a new VHP pass through decontamination chamber

Internal identifier : #01

5.1.1.

Purpose

Main nature of the contract : Supplies

Additional nature of the contract : Services

Main classification ( cpv ): 38000000 Laboratory, optical and precision equipments (excl. glasses)

Additional classification ( cpv ): 33910000 Pathology dissection instruments and supplies, 38543000 Gas-detection equipment, 42123100 Gas compressors, 42514200 Electrostatic air and gas cleaners

Options :

Description of the options : 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.

5.1.2.

Place of performance

Country subdivision (NUTS) : Byen København ( DK011 )

Country : Denmark

5.1.3.

Estimated duration

Duration : 60 Months

5.1.4.

Renewal

Maximum renewals : 8

Other information about renewals : The service agreement, as described in the Contract, may be extended 8 times for a period of 12 months each.

5.1.5.

Value

Estimated value excluding VAT : 4 500 000,00 DKK

5.1.6.

General information

Reserved participation :

Participation is not reserved.

Procurement Project not financed with EU Funds.

The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.9.

Selection criteria

Sources of selection criteria : European Single Procurement Document (ESPD) , Notice

Criterion : General yearly turnover

Description : 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 criteria will be used to select the candidates to be invited for the second stage of the procedure

Criterion : References on specified deliveries

Description : 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.

The criteria will be used to select the candidates to be invited for the second stage of the procedure

Information about the second stage of a two-stage procedure :

Minimum number of candidates to be invited for the second stage of the procedure : 3

Maximum number of candidates to be invited for the second stage of the procedure : 3

The procedure will take place in successive stages. At each stage, some participants may be eliminated

The buyer reserves the right to award the contract on the basis of the initial tenders without any further negotiations

5.1.10.

Award criteria

Criterion :

Type: Price

Name : Price

Description : 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.

Category of award weight criterion: Weight (percentage, exact)

Award criterion number : 30,00

Criterion :

Type: Quality

Name : Assurance of Quality

Description : 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.

Category of award weight criterion: Weight (percentage, exact)

Award criterion number : 25,00

Criterion :

Type: Quality

Name : Solution – Loads and programs

Category of award weight criterion: Weight (percentage, exact)

Award criterion number : 30,00

Criterion :

Type: Quality

Name : Schedule and reliability

Category of award weight criterion: Weight (percentage, exact)

Award criterion number : 15,00

5.1.11.

Procurement documents

Address of the procurement documents : https://eu.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=445496&TID=406755&B=

5.1.12.

Terms of procurement

Terms of submission :

Electronic submission : Required

Address for submission : https://eu.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=445496&TID=406755&B=

Languages in which tenders or requests to participate may be submitted : English

Electronic catalogue : Not allowed

Variants : Not allowed

Tenderers may submit more than one tender : Allowed

Deadline for receipt of requests to participate : 27/01/2026 09:00:00 (UTC+00:00) Western European Time, GMT

Terms of contract :

The execution of the contract must be performed within the framework of sheltered employment programmes : No

Electronic invoicing : Allowed

Electronic ordering will be used : no

Electronic payment will be used : yes

5.1.15.

Techniques

Framework agreement :

No framework agreement

Information about the dynamic purchasing system :

No dynamic purchase system

Electronic auction : no

5.1.16.

Further information, mediation and review

Review organisation : Klagenævnet for Udbud

Information about review deadlines : Pursuant to Section 3 of the Danish Consolidation Act No 593 of 2.6.2016 on the Complaints Board for Public Procurement (available at www.retsinformation.dk), the following time limits for filing a complaint apply: Complaints regarding a Candidate not being prequalified must be filed with the Complaints Board for Public Procurement within 20 calendar days starting the day after the Contracting Authority has sent notification to the Candidates involved, cf. § 7(1) of the Act on The Complaints Board for Public Procurement, provided that the notification includes a short account of the relevant reasons for the decision. Other complaints must in accordance with § 7(2) of the Act on the Complaints Board for Public Procurement be filed with the Complaints Board for Public Procurement within: 1) 45 calendar days after the Contracting Authority has published a contract award notice in the Official Journal of the European Union (with effect from the day following the publication date); 2) 20 calendar days starting the day after the Contracting Authority has published a notice concerning its decision to uphold the contract, cf. § 185(2) of the Public Procurement Act. The complainant must pay a fee of 20.000 DKK when filing a complaint with the Complaints Board. The complainant must inform the Contracting Authority of the complaint in writing at the latest simultaneously with the lodge of the complaint to the Complaints Board for Public Procurement stating whether the complaint has been lodged in the standstill period, cf. § 6(4) of the Act on the Complaints Board for Public Procurement. If the complaint has not been lodged in the standstill period, the complainant must also state whether it is requested that the appeal is granted delaying effect, cf. § 12(1) of the said Act. The email of the Complaints Board for Public Procurement is stated below. The Complaints Board for Public Procurement’s own guidance note concerning complaints is available at the internet address stated below.

Organisation providing information concerning the general regulatory framework for taxes applicable in the place where the contract is to be performed : Konkurrence- og Forbrugerstyrelsen

8. Organisations

8.1.

ORG-0001

Official name : Statens Serum Institut

Registration number : 46837428

Postal address : Artillerivej 5

Town : København S

Postcode : 2300

Country subdivision (NUTS) : Byen København ( DK011 )

Country : Denmark

Contact point : Maria Matzen

Email : maria.matzen@twobirds.com

Telephone : +45 72241212

Buyer profile : https://eu.eu-supply.com/ctm/company/companyinformation/index/244516

Roles of this organisation :

Buyer

8.1.

ORG-0002

Official name : Klagenævnet for Udbud

Registration number : 37795526

Postal address : Nævnenes Hus, Toldboden 2

Town : Viborg

Postcode : 8800

Country subdivision (NUTS) : Østjylland ( DK042 )

Country : Denmark

Email : klfu@naevneneshus.dk

Telephone : +45 35291000

Internet address : https://erhvervsstyrelsen.dk/klagevejledning-0

Roles of this organisation :

Review organisation

8.1.

ORG-0003

Official name : Konkurrence- og Forbrugerstyrelsen

Registration number : 10294819

Postal address : Carl Jacobsens Vej 35

Town : Valby

Postcode : 2500

Country subdivision (NUTS) : Byen København ( DK011 )

Country : Denmark

Email : kfst@kfst.dk

Roles of this organisation :

Organisation providing information concerning the general regulatory framework for taxes applicable in the place where the contract is to be performed

8.1.

ORG-0004

Official name : Mercell Holding ASA

Registration number : 980921565

Postal address : Askekroken 11

Town : Oslo

Postcode : 0277

Country subdivision (NUTS) : Oslo ( NO081 )

Country : Norway

Contact point : eSender

Email : publication@mercell.com

Telephone : +47 21018800

Fax : +47 21018801

Internet address : http://mercell.com/

Roles of this organisation :

TED eSender

Notice information

Notice identifier/version : ba634853-8012-4cd4-bec8-154c2ca7fa56 - 01

Form type : Competition

Notice type : Contract or concession notice – standard regime

Notice subtype : 16

Notice dispatch date : 18/12/2025 08:45:37 (UTC+00:00) Western European Time, GMT

Notice dispatch date (eSender) : 18/12/2025 10:00:53 (UTC+00:00) Western European Time, GMT

Languages in which this notice is officially available : English

Notice publication number : 846489-2025

OJ S issue number : 245/2025

Publication date : 19/12/2025