Framework agreement for the procurement of control measurements and revalidation of clean rooms and equipment

Description

A new framework agreement will be procured for control measurements and revalidation of clean rooms and equipment (insulators, UDF-benches, terminal filters) for Sykehusapotekene HF. The contract with the current supplier will expire at the end of the first half of 2022. The rooms, including equipment placed in the rooms, are used for the production of medicines (including cytostatika and other aseptic production). The pharmacies come under supervision from Statens Legemiddelverk (SLV). The premises and equipment are classified in accordance with GMP (Good Manufacturing Practice). Lot 1: The contracting authority for this contest is Sykehusapotekene HF (SAHF), which is owned by Helse Sør-Øst RHF. The pharmacies in SAHF vary in size, number of rooms, and equipment. 14 locations (16 production premises) will be included in this framework agreement. The word involves, amongst other things, particle measuring in classified cleanrooms, integrity testing of roof filters, control of UFD, safety benches and insulators, measuring and revalidation of clean room ventilation. Important considerations that affect the purpose of the procurement: - The premises that will be tested are in daily use, and even if one tries to adapt work/activities whilst the testing is being carried out, it will, due to operational considerations, be necessary for parts of the work to occur in the late afternoons and/or on Saturdays. - It is also important that the work is carried out during as short a period as possible. In some locations the controls must be carried out in rooms without staff, i.e., 'at rest'. - All documentation must be suitable for external review and it must be available quickly after the assignment. - It is also important that the work is carried out during as short a period as possible. - The premises must be validated at one year intervals, as agreed with the individual location. The work must be planned in good time.