When dealing with sterile pharmaceutical productions there are two main aspects to be considered: products’ protection and operators’ safety.
It is therefore of utter importance to minimize human intervention to reduce the risk of product contamination and guarantee the highest protection towards the operators.
The isolator, being a physical barrier, allows the implementation of a successful contamination control strategy, with full automated process and monitoring system, as well as minimum human intervention.
Assembly of parts and loading of components in line with the aseptic process
High grade stainless steel isolator, fully integrated on machine base
GMP Grade A environment (ISO 4.8)
Laminar Air Flow
Air tightness compliant to Class III (according to ISO 10648:2)
Automatic leak test (including bellows leak test)
Integrated WIP/CIP systems
Bi-Bo filter units
Inlet & Outlet HEPA 14 filters
Containment up to OEB 5
Optimized automatic bio-decontamination systems (VPHP and aHP)
Aseptic transfer systems
Full compliance to GAMP 5, 21 CFR part 11