Pharmaceutical Isolator Systems For Aseptic And High-Potent Applications
Isolator systems are becoming increasingly important to the pharmaceutical industry. The improvement in product quality, the reduction of operating costs and the capability of longer production runs are significant advantages in comparison to conventional clean room production.
Complex filling lines require competent management of the interaction between filling machine, isolator system and subsequent machines, e.g. freeze-drying systems or over seal capping machines. Challenges include the safe functioning of the interfaces, the simplicity of the overall controls system and easy of operation of the individual components. This is what induced Syntegon to offer everything from one source. This makes Syntegon the ideal partner for concept planning and the most reliable partner for implementation of isolator projects. In combination with the SafeVAP a bio-decontamination system, developed by Syntegon, the isolator offers the ideal conditions for fast and stable decontamination processes.
- Worldwide references with recognition from different authorities (i.e. FDA, EMA, cFDA, etc.)
- Integrated system consisting of filling/closing machine, isolator, H2O2 bio-decontamination as well as HVAC technology
- Process know-how (bio-decontamination with H2O2, wash-down processes, etc.)
- Fast and highly effecient bio-decontamination cycles using Syntegon‘s own integrated and fully validated SafeVAP bio-decontamination system
- Isolators for product and personal protection requirements when processing highly potent products
- Integration of entire range of peripheral equipment (e.g. H2O2 airlocks for material transfer, transfer systems, wireless glove testing system, etc.)
- Documented mock-up study of the integrated system filling machine with isolator