SKAN VarioSys-Isolator (PSI-L 2.0)
All these features, coupled with the unique L-shaped flange that enables a very quick exchange of precisely tailored modules, ensure a universal sterile working environment for aseptic and/or highly active pharmaceutical products. For highly active products, the system has suitable options so that the process can be implemented safely.
The growing automation of processes means that manufacturers and suppliers face new challenges when it comes to plant safety. In order to ensure the highest process safety possible, the VarioSys-isolator provides a special option for integrating robots inside it. This includes parts such as a reinforced working chamber, tamper protection, and a special front panel.
Wide range of combination possibilities
The modules' wide range of combination possibilities mean that the requirements of the most varying production processes can be fulfilled. The modules can be easily and quickly exchanged inside the isolators. Depending on the production process, the system can be loaded via a mousehole, the quick airlock SARA-XL, or a sterilization tunnel. The process output can be realized via a mousehole, the airlock or a bag-out system. Furthermore, one or more freeze dryers of different sizes can be integrated. This forms a valuable and flexible production system.
- Isolator with modules that can be exchanged quickly and simply
- The use of an empty flange plate guarantees maximum flexibility, even when adapting to future processes
- Aseptic production through H2O2 decontamination of the isolator
- Toxic processes can be illustrated
- Robot safety to minimize risk to operator and process
- Quick H2O2 decontamination of the material airlock with SKANFOG technology
- Excellent operator protection through safely exchangeable FiPa filters
- Suitable for many different sizes and types of ready-to-use packaging material
SKANFOG H2O2 micro-atomization
Controlling the microbial load within A/B cleanroom classes is a daily challenge. Surface decontamination of the equipment is a time-consuming procedure, and validation is often complex. SKANFOG is a decontamination technology based on the micro-atomization of hydrogen peroxide (H2O2). Compared with conventional decontamination, it simplifies and enhances both process flow and validation. Moreover, nebulized H2O2 in moderate concentrations can be used without concern for toxicity, corrosion and persistence. Scientific studies have shown that a total kill of a 106 population of the test organism Geobacillus stearothermophilus can be achieved and reproduced. SKAN are experts in H2O2 decontamination processes and provides support in all phases of cycle development and microbiological validation.