High Pressure Homogenizer Services - cGMP Validation Services

By: Niro Soavi  09-12-2011
Keywords: Technical Services, Pressure Homogenizers

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.

Keywords: Pressure Homogenizers, Technical Services,

Other products and services from Niro Soavi


High Pressure Homogenizer Services - Product Testing Laboratory

It has its own highly qualified staff to perform product testing on customers’ behalf and advise on product formulation to obtain the most efficient homogenization effect on products. It is available to customers to test the application of homogenisation on products and to refine those products development using the benefit of in-house equipment.