How to validate Robotics Equipment for Pharma to stay aligned with guidelines?
Pharma Industry Requirements for Robots in an Aseptic Environment
Hygienic design is central to a robot working in an aseptic environment. A robot’s entire outer surface must stay clean and resist vaporized hydrogen peroxide during decontamination procedures. Moving parts can’t generate air particles or affect laminar air flow required by ISO 5 standards. These demands impact robot design, including materials, joints, surface roughness and movement.
Stäubli Stericlean robots were run through SKANalytix’s intensive tests. The six tests evaluated specific factors that could affect robot performance or isolator conditions, from cleanability and chemical and microbiological resistance, to particle emissions and surface roughness.