RV Re-Qualifizierung GMP- und OP-Bereiche

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The subject of the procurement is the performance of requalification services in various GMP and operating theatre (OP) areas of the University Hospital Jena. The scope of services includes, in particular, seal seating and leak tests on HEPA filters, cleanroom classification and particle measurements, physical measurements such as air volumes, air change rates, room air temperatures, room air humidity levels 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 specification (service description). The services are intended to provide evidence and documentation of the required operating condition of the respective areas. The requalification 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 specification. The work is to be carried out partly under cleanroom conditions and in cleanroom garments. After completion of the respective requalification services, the corresponding test and results documentation must be prepared and handed over…

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