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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