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.