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Equipments for Pharmaceutical and Biotechnology applications must be fully compliant with the stringent applicable regulations, such as FDA requirements and cGMP Guidelines.
GEA Niro Soavi can supply not only high pressure homogenizers compliant with the regulations in force in the industry, but also highly qualified technical services to easily and safely implement the high pressure homogenizer into cGMP validated facilities and processes.
Every step of the homogenizer validation process is documented and recorded using reference class validations tools, developed in years of partnership and cooperation on cGMP validated projects with leading worldwide pharmaceutical and biotech companies, and backed-up by hundreds installations.
GEA Niro Soavi services include preparation of customized FAT, SAT and IQ/OQ protocols, maintenance planning and on-site training programs, and tailored support for PQ when required to guarantee straightforward and successful equipment and process validation.