The STISO sterility test isolator is ideal for aseptic (STISO) and aseptic-high-potency (STISOhp) applications, such as:
Optimizing decontamination processes at an early stage ensures efficient start to production. An internal VPHP simulation identifies H₂O₂ saturation zones, followed by STISO pre-cycle tests to homogenize the distribution. The parameters obtained create the basis for cycle development and validation. Further research into injection rate, temperature and gas distribution, and aeration refine the process. With STISO pre-cycle development, all important parameters are predefined – allowing for reduced on-site support and a faster production start.
The STISO’s Environmental Monitoring System (EMS) monitors temperature, humidity, pressure, and particle load in the isolator. It also ensures compliance with regulatory requirements and increases product safety. Sensors, data logs, and central software continuously record and analyze measured values. Alarms are triggered in the event of deviation. Remote monitoring is possible through a user-friendly interface. EMS detects deviations at an early stage, minimizes contamination risks, and stabilizes processes.