The built-in VHP sterilization system in the Sterility Test Isolator employs a novel rapid VHP sterilization technology, which effectively penetrates HEPA filters and achieves a log6 microbial reduction with biological indicators, without any form of condensation occurring. The Sterility Test Isolator undergoes leak detecting in strict accordance with international standards, achieving ≤0.5% Vol/hr. With excellent integration capabilities, it utilizes a Siemens PLC control system for fully automated intelligent control, ensuring stable and reliable operation of all integrated components. It can integrate environmental monitoring equipment such as particle counters and microbial samplers. The graphical human-machine interface offers storage, electronic export, or printing of sterilization data and environmental monitoring reports based on customer requirements. The control system design complies with GAMP5 guidelines and meets the requirements of 21 CFR Part 11 for electronic records, electronic signatures, and audit trail. CD/CV services are available to optimize sterilization parameters and shorten sterilization cycles while ensuring sterilization effectiveness, helping users save validation costs and time based on actual processes. Mock-up validation is also offered, allowing customers to simulate the ergonomic rationality of the isolator on-site.