Its core functions include:
Sterility assurance: In the production of sterile preparations (such as injections and biological products), maintain a Class A clean environment to prevent microbial contamination.
Cross-contamination prevention and control: In the production of APIs or highly active drugs (such as cytotoxic drugs and hormones), avoid the leakage of harmful substances and protect personnel and environmental safety.
Process stability: Reduce human intervention and reduce the impact of environmental fluctuations on product quality.

Desempenho e recursos

1. Comprehensive product portfolio:isolation systems for water injection, powder injection, prefilled syringe and sterile powder production lines;
2. Stable and reliable environment:reliable and stable class A environment, which meets cGMP, FDA, ISO, ISPE, and pharmacopoeia requirements;
3. Nova tecnologia VHPS:the latest H₂O₂ sterilization system, which can achieve rapid sterilization, control the concentration and saturation of H₂O₂, with good sterilization reproducibility;
4. Sistema de controle inteligente:Sistema de controle Siemens PLC+IPC; alarmes inteligentes de pressão, H₂O₂ concentração da solução, temperatura e umidade, velocidade do ar e outros parâmetros de monitoramento; o sistema tem controle de acesso em vários níveis; está em conformidade com os requisitos do FDA 21 CFR parte 11;
5. Independent temperature and humidity control mode:with the integrated independent air conditioning system, it can realize that the internal temperature and humidity in the chamber is not affected by the external environment;
6. MOCK-UP:complete wood model verification service, ergonomic operation qualification and 3D model display service in the middle of the project.
7. Sterilization process development support: qualification and validation services for sterilization cycle development of the whole process can be provided;
8. Customization:support customized isolation system design, and provide systematic closed isolation solutions and CE certification services;
9. Integrated monitoring system: integrated monitoring systems of temperature and humidity, differential pressure, air speed, H₂O₂concentration, optical grating, particles and airborne viable bacteria, etc.;
10. Multiple sterile transfer solutions:multiple and combined sterile transfer solutions are available to meet customers’ diversified production needs;
11. Complete life cycle support:covering consulting, project design, installation scheme design and verification design, etc.;
12. Detector de vazamento de luvas sem fio: multi-head wired glove leakage detector or wireless glove leakage detector is optional;
13. Serviço CDCV:desenvolvimento de ciclos de esterilização, estudos de validação e serviços;