RV Re-Qualifizierung GMP- und OP-Bereiche

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The subject of the procurement is the provision of re-qualification services in various GMP and operating room (OP) areas of the Universitätsklinikum Jena. The scope of service includes, in particular, seal seat and leak tests on HEPA filters, cleanroom classifications and particle measurements, physical measurements such as air volumes, air change rates, room air temperatures, room air humidities and room differential pressures, as well as microbiological investigations. The required tests and measurements shall be carried out in accordance with the requirements and test intervals specified in the specifications (terms of reference). The services are intended to provide evidence and documentation of the required operating status of the respective areas. The re-qualification is carried out in particular taking into account the requirements of GMP Annex 1:2022 as well as the relevant standards and regulations named in the specifications. The work is to be carried out partly under cleanroom conditions and in cleanroom clothing. Upon completion of the respective re-qualification services, corresponding test and results documentation is to be prepared and handed over to the…

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