The handling of highly active ingredients during filling and packaging processes poses particular demands on the protection of people and the environment. At the same time, it must be guaranteed that no impurities enter into the final product and that all production processes proceed smoothly and efficiently from setting up to cleaning. A holistic approach, considering all process steps and interfaces, the “Hazard Evaluation”, makes Harro Höfliger a specialist in the field of containment and aseptic systems for reliable operator and/or product protection.
Depending on the application and OEL (Occupational Exposure Limit) requirements, GMP-compliant containment concepts, from simple, controlled local exhaust ventilation up to isolators are used. Harro Höfliger implements systems including APE (Advanced Protection Enclosure), high-containment concepts such as ABS (Advanced Barrier System) in isolator version and RABS (Restricted Access Barrier System) for aseptic product protection.
• Comprehensive approach with individual risk assessment
• Experience in the field of OEL limits below 0.05 µg/m³
• Using mock-up studies, machine ergonomics and processes are optimized and the positions for the transfer systems and glove ports defined.
• Customized and standardized, modular concepts
• Good cleanability of barrier systems
• Intelligent systems for transfer of material into and out of the barrier system
• Numerous implemented machines for processes under an inert gas atmosphere