Pharmaceutical and Biotechnology applications require specifically designed equipment which must be fully compliant with the stringent applicable regulations, such as FDA, ASME BPE requirements and cGMP Guidelines.
GEA Niro Soavi VHP technology is the leading solution for cells disruption, biotech and pharmaceutical applications, and is backed-up by more than 50 years of experience in aseptic process, CIP cleanable equipment and hundreds of successful installations worldwide.
These specific competences are applied to the GEA Niro Soavi VHP design combined into a unique solution in both the high pressure functionality features and the most effective SIP-able and CIP-able homogenizer design.
GEA Niro Soavi Aseptic configuration allows SIP on the process side and on the
aseptic containment system for sterile product processes. Product contact materials and surface finishes are selected to comply not only with functional requirements but also with the applicable FDA regulations.
A complete documentation package, based on years of partnerships with worldwide pharmaceutical and biotech companies, is available to implement our high pressure homogenizers into cGMP validated facilities and processes. It includes wetted parts traceability, materials certificates and surface roughness reports.
GEA Niro Soavi can provide customers with focused and competent support in the validation of high pressure homogenizing processing equipment, with specific FAT, SAT and IQ/OQ protocols, maintenance and operational on-site training, and customized service solutions.
All machines can be supplied with full ATEX directive compliance for hazardous areas.
