Validation clean room ventilation in production premises, LAF-benches and insulators

Sjukehusapoteka Vest HF

The contracting authority would like tenders for the validation of clean room ventilation in premises in tSjukehusapoteka Vest and the Centre for Nuclear Medicine in Helse Bergen, that is used for the production of medicines, including LAF-units that are placed in the rooms.
The assignments shall be carried out for Sjukehusappoteka Vest and Helse Bergen.
Sjukehusapoteka Vest consists of 4 pharamacies, the hospital pharmacy in Bergen, the hospital pharmacy in Stavanger, the hospital pharmacy in Førde and the hospital pharmacy in Haugesund. All the four hospital pharmacies produce aseptically prepared medicines for their own customers and their own hospitals. In addition the hospital pharmacy in Bergen produces orders from the other hospital pharmacies in SAV in addition to being one of the three hospital pharmacies that participate in a national scheme for the production of sterile medicines.
Daily radioactive medicines are producted at the Centre for Nuclear Medicine/the PET centre under aseptic production. There is no danger of radioactive exposure for operators and the Centre for Nuclear Medicine/PET is legally charged with taking care of external personnel's safety.

Frist

Fristen for mottak av tilbud var 2014-09-09. Anskaffelsen ble publisert 2014-07-08.

Hvem? Hva? Hvor?
Anskaffelseshistorikk
Dato Dokument
2014-07-08 Kunngjøring av konkurranse
Kunngjøring av konkurranse (2014-07-08)
Gjenstand
Anskaffelsens omfang
Tittel: Air pollution protection services
Antall eller omfang:
The contracting authority would like tenders for the validation of clean room ventilation in premises in Sjukehusapoteka Vest and in the Centre for Nuclear Medicine (the PET centre) in Helse Bergen, which are used for the production of medicines, including LAF units that are placed in the rooms. The premises, as the LAF units are classified in accordance with GMP(Good Manufacturing Practice). See the following page for further information on GMP: http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htmSjukehusapoteka Vest consists of 4 pharamacies, the hospital pharmacy in Bergen, the hospital pharmacy in Stavanger, the hospital pharmacy in Førde and the hospital pharmacy in Haugesund. All the four hospital pharmacies produce aseptically prepared medicines for their own customers and for their own hospital. The hospital pharmacy in Bergen produces, in addition, orders from the other hospital pharmacies in SAV, and it is one of the hospital pharmacies that participate in a national scheme for the production of sterile medicines.In Helse Bergen the procurement is for the Centre for Nuclear Medicine/the PET centre.Daily radioactive medicines are producted at the Centre for Nuclear Medicine/the PET centre under aseptic production. There is no danger of radioactive exposure for operators and the Centre for Nuclear Medicine/PET is legally charged with taking care of external personnel's safety.See annex 5 for a description of the premises, equipment and tests.The premises shall be validated with one year intervals, as agreed with each place. The work must be planned in good time.In addition tenderers must carry out extraordinary limited testing e.g. after new procurements, in connection with construction activities etc.I addition to the stated validation assignments, tenderers must be able to carry out simple maintenance/repair assignments that are uncovered during testing e.g. sealing/replacing HEPA filters, minor leak testing of HEPA filters and contribute to professional problems that arise during the testing.The premises that shall be tested are in daily use and even if one tries to adapt work/activities whilst the testing is being carried out, it will be necessary for parts of the work to be carried out both in the late afternoon/evening and at weekends. It is also important that the work is carried out during as short a period as possible. As regards the Centre for Nuclear Medicine, there will always be qualified personnel in the premises. External personnel will therefore always be taken care of by internal personnel.Tenderers must also be able to carry out extraordinary «sub validations» resulting from technical problems or external conditions such as, e.g. construction/blasting in the area surrounding the production premises.1 800 000
Vis mer
Totalverdi for anskaffelsen: 1 800 000 💰
Metadata for kunngjøring
Originalspråk: engelsk 🗣️
Dokumenttype: Kunngjøring av konkurranse
Kontraktens art: Tjenester
Forskrift: Det europeiske økonomiske samarbeidsområdet (EØS), med deltakelse av GPA-land
Felles innkjøpsordliste (CPV)
Kode: Beskyttelse mot luftforurensning 📦

Prosedyre
Prosedyretype: Åpen anbudskonkurranse
Tilbudstype: Innlevering for alle delkontrakter
Tildelingskriterier
Det mest økonomisk fordelaktige tilbudet

Oppdragsgiver
Identitet
Land: Norge 🇳🇴
Type tildelende myndighet: Nasjonalt eller føderalt byrå/kontor
Navn på tildelende myndighet: Sjukehusapoteka Vest HF
Postadresse: Møllendalsbakken 9
Postnummer: 5009
Poststed: Bergen
Kontakt
E-post: hilde.wangen@sav.no 📧
Telefon: +47 97764358 📞

Referanse
Datoer
Sendt dato: 2014-07-08 📅
Innleveringsfrist: 2014-09-09 📅
Publiseringsdato: 2014-07-11 📅
Identifikatorer
Kunngjøringsnummer: 2014/S 131-235066
OJ-S-utgave: 131

Gjenstand
Anskaffelsens omfang
Hyppighet av kontraktene som skal tildeles: See the tender documents.
Kort beskrivelse:
The contracting authority would like tenders for the validation of clean room ventilation in premises in tSjukehusapoteka Vest and the Centre for Nuclear Medicine in Helse Bergen, that is used for the production of medicines, including LAF-units that are placed in the rooms.
Vis mer
The assignments shall be carried out for Sjukehusappoteka Vest and Helse Bergen.
Sjukehusapoteka Vest consists of 4 pharamacies, the hospital pharmacy in Bergen, the hospital pharmacy in Stavanger, the hospital pharmacy in Førde and the hospital pharmacy in Haugesund. All the four hospital pharmacies produce aseptically prepared medicines for their own customers and their own hospitals. In addition the hospital pharmacy in Bergen produces orders from the other hospital pharmacies in SAV in addition to being one of the three hospital pharmacies that participate in a national scheme for the production of sterile medicines.
Vis mer
Daily radioactive medicines are producted at the Centre for Nuclear Medicine/the PET centre under aseptic production. There is no danger of radioactive exposure for operators and the Centre for Nuclear Medicine/PET is legally charged with taking care of external personnel's safety.
Vis mer
Antall eller omfang:
The contracting authority would like tenders for the validation of clean room ventilation in premises in Sjukehusapoteka Vest and in the Centre for Nuclear Medicine (the PET centre) in Helse Bergen, which are used for the production of medicines, including LAF units that are placed in the rooms. The premises, as the LAF units are classified in accordance with GMP(Good Manufacturing Practice). See the following page for further information on GMP: http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm
Vis mer
Sjukehusapoteka Vest consists of 4 pharamacies, the hospital pharmacy in Bergen, the hospital pharmacy in Stavanger, the hospital pharmacy in Førde and the hospital pharmacy in Haugesund. All the four hospital pharmacies produce aseptically prepared medicines for their own customers and for their own hospital. The hospital pharmacy in Bergen produces, in addition, orders from the other hospital pharmacies in SAV, and it is one of the hospital pharmacies that participate in a national scheme for the production of sterile medicines.
Vis mer
In Helse Bergen the procurement is for the Centre for Nuclear Medicine/the PET centre.
Daily radioactive medicines are producted at the Centre for Nuclear Medicine/the PET centre under aseptic production. There is no danger of radioactive exposure for operators and the Centre for Nuclear Medicine/PET is legally charged with taking care of external personnel's safety.
Vis mer
See annex 5 for a description of the premises, equipment and tests.
The premises shall be validated with one year intervals, as agreed with each place. The work must be planned in good time.
In addition tenderers must carry out extraordinary limited testing e.g. after new procurements, in connection with construction activities etc.
I addition to the stated validation assignments, tenderers must be able to carry out simple maintenance/repair assignments that are uncovered during testing e.g. sealing/replacing HEPA filters, minor leak testing of HEPA filters and contribute to professional problems that arise during the testing.
Vis mer
The premises that shall be tested are in daily use and even if one tries to adapt work/activities whilst the testing is being carried out, it will be necessary for parts of the work to be carried out both in the late afternoon/evening and at weekends. It is also important that the work is carried out during as short a period as possible. As regards the Centre for Nuclear Medicine, there will always be qualified personnel in the premises. External personnel will therefore always be taken care of by internal personnel.
Vis mer
Tenderers must also be able to carry out extraordinary «sub validations» resulting from technical problems or external conditions such as, e.g. construction/blasting in the area surrounding the production premises.
Beskrivelse av opsjoner: The contract has an option for an extension for 1+1 year.
Antall mulige forlengelser: 2
Tidsramme for senere kontrakter: 12 måneder
Referansenummer: 2014/128
Utførelsessted
Hovedsted eller utførelsessted: Bergen, Norway.

Juridisk, økonomisk, finansiell og teknisk informasjon
Vilkår for deltakelse
Egnethet til å utøve yrkesvirksomheten: See the tender documents.
Økonomisk og finansiell stilling: See the tender documents.
Minste nivå(er) av standarder: See the tender documents.
Teknisk og faglig kapasitet: See the tender documents.

Prosedyre
Varighet av rammeavtalen i måneder: 48
Tilbudets gyldighetsperiode: 2015-02-02 📅
Språk
Språk: dansk 🗣️
svensk 🗣️
Andre språk: Norwegian.

Oppdragsgiver
Identitet
Nasjonalt registreringsnummer: 983974716
Navn på tildelende myndighet: Helse Bergen HF
Nasjonalt registreringsnummer: 983974724
Postadresse: Jonas Lies Vei 65
Postnummer: 5021
Kontakt
Kontaktpunkt: Hilde Wangen
Adresse til kjøperprofilen: https://kgv.doffin.no/ctm/Supplier/CompanyInformation/Index/3430 🌏
URL for dokumenter: https://kgv.doffin.no/ctm/Supplier/Documents/Folder/119506 🌏

Referanse
Datoer
Startdato: 2014-10-01 📅
Sluttdato: 2016-09-30 📅
Identifikatorer
Referansenummer tildelt av oppdragsgiver: 2014/128
Kilde: OJS 2014/S 131-235066 (2014-07-08)
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