The supply of two Sterility test Isolators, one Bio-safety Isolator and related services

Netherlands Vaccin Institute

The objective of this tender is to fulfill the need of two Sterility test Isolators, one Bio-safety Isolator and related services, by one supplier.

Deadline

De termijn voor de ontvangst van de offertes was 2011-09-19. De aanbesteding werd gepubliceerd op 2011-07-28.

Leveranciers

De volgende leveranciers worden genoemd in gunningsbesluiten of andere aanbestedingsdocumenten:

• Tecnilab-BMI B.V.

Wie?

• Netherlands Vaccin Institute

Wat?

• Laboratoriuminstrumenten, optische en precisie-instrumenten (uitgezonderd brillen) › Controle- en testapparatuur

Waar?

• Utrecht › Utrecht

Aankoopgeschiedenis

Datum	Document
2011-07-28	Aankondiging van een opdracht
2011-12-05	Award Aankondiging

Aankondiging van een opdracht (2011-07-28)
Object
Toepassingsgebied van de aanbesteding
Titel: Laboratoriuminstrumenten, optische en precisie-instrumenten (uitgezonderd brillen)
Hoeveelheid of omvang:

The supply of two Sterility test Isolators, one Bio-safety Isolator and related services.

Aankondigingsmetadata
Originele taal: Engels 🗣️
Documenttype: Aankondiging van een opdracht
Aard van de opdracht: Leveringen
Regelgeving: Europese Unie, met GPA-deelname
Gemeenschappelijke woordenlijst overheidsopdrachten (CPV)
Code: Laboratoriuminstrumenten, optische en precisie-instrumenten (uitgezonderd brillen) 📦

Procedure
Type procedure: Openbare procedure
Type bod: Inschrijving voor alle percelen
Gunningscriteria
Uit economisch oogpunt voordeligste inschrijving

Aanbestedende dienst
Identiteit
Land: Nederland 🇳🇱
Type aanbestedende dienst: Ministerie of elke andere nationale of federale instantie
Postadres: Antonie van Leeuwenhoek 9-11
Postcode: 3721 MA
Poststad: Bilthoven
Contact
Internetadres: http://www.nvi-vaccin.nl 🌏
E-mail: andre.wolterink@nvi-vaccin.nl 📧
Telefoon: +31 302744775 📞

Referentie
Datums
Verzenddatum: 2011-07-28 📅
Indieningstermijn: 2011-09-19 📅
Publicatiedatum: 2011-08-02 📅
Identificatoren
Aankondigingsnummer: 2011/S 146-242543
PB-S nummer: 146
Aanvullende informatie

The Tenderer may request Purchaser by e-mail ultimately 24.8.2011 15:00 hrs for clarification of any aspect of the tender documents. The Tenderer must use the attached annex L of the ITT “Clarification request form” to present his questions.

Object
Toepassingsgebied van de aanbesteding
Korte beschrijving:

The objective of this tender is to fulfill the need of two Sterility test Isolators, one Bio-safety Isolator and related services, by one supplier.

Plaats van uitvoering
Hoofdlocatie of plaats van uitvoering: Bilthoven, The Netherlands.

Juridische, economische, financiële en technische informatie
Voorwaarden voor deelname
Geschiktheid om de beroepsactiviteit uit te oefenen:

The latest certified statement of trade register of the relevant register of companies in accordance with article 46 of Council Directive 2004/18/EC. This evidence of registration must not have been issued longer than 6 (six) months before the closing date of this tender.

Economische en financiële draagkracht: Financial and economic standing.
Minimumeisen:

1. Tenderer shall issue (as part of its tender) a prove of insurance of at least EUR 2 000 000 yearly (two million Euros) against any damage incurred by Purchaser as a consequence of Tenderers failure to perform any of its obligations, or as a consequence of a wrongful act committed against Purchaser of a third party. The insurance shall amongst others cover product liability.

2. The annual statement of accounts of Tenderer does not contain a paragraph which shows that the company is unable to continue its activities. With regard to this annual statement of accounts also applies that no negative auditors’ certificate has been issued. If a tender is submitted by a combination, the same applies for this combination.

3. Tenderer disposes of a turnover of at least EUR 1 500 000,- (one point five million Euros) for the financial year 2010. If a tender is submitted by a combination, the same applies for this combination.

4. In view of the aforementioned requirements Tenderer will (as part of its tender) issue the annual report and the annual statement of accounts for the financial year 2010, (at least consisting of balance sheets and a profit and loss statement accompanied by a clarification of 2010), drawn up by an auditor as mentioned under section 2:393, paragraph 1 of the Dutch Civil Code or a similar officer from the country of establishment of the Tenderer.

5. If Tenderer belongs to a group (Dutch: “groep”) in accordance with article 2:403 of the Dutch Civil Code (or its equivalent according to foreign law) and its financial data have been consolidated by another legal body or private/public limited company in a consolidated annual statement of accounts, Tenderer is entitled to submit (as part of its tender) such consolidated annual statement of accounts for the financial year 2010 accompanied with the annual report for the financial year 210 (in stead of the documents asked for in paragraph 4). In this event Tenderer will also provide purchaser (as part of its tender) with a declaration of said legal body or private/public limited company in which it states that it declares itself severally liable for debts arising from legal acts executed by Tenderer.

6. If, for any valid reason, the Tenderer is unable to provide the requested documents, Tenderer may prove his economic and financial standing by any other document which Purchaser considers appropriate.

Technische en professionele bekwaamheid:

1) Experience with the supply of Sterility test Isolators and Bio-safety Isolators and related services.

2) Quality guidelines and quality assurance.

3) Corporate social responsibility.

Minimumeisen:

Ad 1).

The Tenderer’s best matching principal delivery of one Sterility test Isolator and related services, other than the delivery to NVI, effected in the past 3 years stating the following data:

a. The clients name, country and contact information, public or private

b. Delivery date of the Isolator

c. Brief specification and further details of the delivered Isolator

d. Total value of the contract

Tenderer should justify his statement by certificates of good performance of both the supply and maintenance of the Sterility test Isolator, issued or countersigned by the competent authority (in case of public authorities) or by the client (in case of private companies).

Purchaser reserves the right, if it deems necessary, to request evidence from the parties to whom the invitation to tender will be sent, as referred to in Article 45 of Directive 2004/18/EG. If an applicant can not produce these documents within 10 working days of the request, he will be excluded from the invitation to tender.

The Tenderer’s best matching principal delivery of one Bio-safety Isolator and related services, other than the delivery to NVI, effected in the past 3 years stating the following data:

Tenderer should justify his statement by certificates of good performance of both the supply and maintenance of the Bio-safety Isolator, issued or countersigned by the competent authority (in case of public authorities) or by the client (in case of private companies).

Ad 2).

1. The Sterility test Isolators and the Bio-safety Isolator should be validated according to the current GMP, and GAMP guidelines. The Tenderer has to be familiar with these guidelines and has to prove that it has relevant experience with these guidelines. Tenderer must submit a copy of the latest certicate of GMP compliance of a manufacturer.

2. A description of Tenderer’s internal quality system or preferably ISO 9001:2008. The internal quality procedures should be available for review by NVI. NVI reserves the right to audit the Tenderer’s quality system before contract award.

3. A description of Tenderer’s Deviation and Change Control procedures in order to prove and ensure the validated state of the supplied software and equipment.

4. Tenderer should prove that personnel, involved in the development of the Sterility test Isolators and the Bio-safety Isolator, have been adequately trained.

Ad 3).

Tenderer must declare that a clear and effective policy on corporate social responsibility and sustainability is present, reflecting the explicit adoption by Tenderer of economic (profit), social (people) and environmental (planet) goals as voluntarily integrated concerns in all business operations and interactions with stakeholders.

Such policy is present and is in compliance with the relevant guidelines for sustainability as issued by the OECD (Guidelines for Multinational Enterprises, 2008) and / or the Dutch equivalent directive (Richtlijn 400 Jaarverslag, jo. Art. 2:391 lid 1 BW).

Uitvoering van de opdracht
Vereiste deposito's en garanties: Not applicable.
Belangrijkste financieringsvoorwaarden en betalingsregelingen en/of verwijzing naar de relevante bepalingen die daarop van toepassing zijn:

A bank guarantee for the first 30 % of the payment of the supply of the Isolators.

Rechtsvorm van de combinatie van ondernemers aan wie de opdracht wordt gegund: Not applicable.

Procedure
Geldigheidsduur van de inschrijving: 6 maanden
Datum opening inschrijvingen: 2011-09-19 📅
Plaats van opening: Bilthoven, The Netherlands.
Plaats: Bilthoven, The Netherlands.
Gunningscriteria
Criterium: 1. Total Cost of Ownership (56)
2. Delivery dates (10)
3. The extent to which the technical specifications of the Sterility test Isolators are met (17)
4. The extent to which the technical specifications of the Bio-safety Isolator are met (17)
Talen
Taal: Engels 🗣️

Aanbestedende dienst
Identiteit
Naam aanbestedende dienst: Netherlands Vaccin Institute
Contact
Contactpunt: Netherlands Vaccin Institute
Andre Wolterink

Aanvullende informatie
Beoordelingsorgaan
Naam: Disputes shall be submitted to the judgment of the competent court of The Hague.
Bron: OJS 2011/S 146-242543 (2011-07-28)

Award Aankondiging (2011-12-05)
Object
Aankondigingsmetadata
Documenttype: Award Aankondiging

Procedure
Type procedure: Onderhandelingsprocedure zonder een oproep tot mededinging
Type bod: Niet van toepassing

Referentie
Datums
Verzenddatum: 2011-12-05 📅
Publicatiedatum: 2011-12-07 📅
Identificatoren
Aankondigingsnummer: 2011/S 235-380178
Verwijst naar aankondiging: 2011/S 146-242543
PB-S nummer: 235

Procedure
Gunningscriteria
Criterium: 3. The extent to which the tecnical specifications of the Sterility test Isolators are met (17)

Gunning van het contract
Datum van sluiting van de overeenkomst: 2011-12-05 📅
Naam: Tecnilab-BMI B.V.
Postadres: Brouwer 6
Poststad: Someren
Postcode: 5711 LD
Land: Nederland 🇳🇱
Informatie over aanbestedingen
Aantal ontvangen offertes: 5
Bron: OJS 2011/S 235-380178 (2011-12-05)

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