Shanghai Marya China Supplier Pharmaceutical Inspection Cell Therapy Isolator System for Sterility Processing

Class A Sterile Environment: Complies with China GMP, EU GMP, FDA, and cGMP requirements for sterile testing and dispensing.

Advanced VHPS Technology: Controls H2O2 concentration and saturation for high reproducibility and shortened sterilization time.

Modular Design: Includes transfer chamber, operation chamber, and bacteria collector for easy installation and transport.

Intelligent PLC Control: Siemens PLC+IPC system with multi-level access control and alarms for pressure, temperature, and humidity.

FDA 21 CFR Part 11 Compliant: System meets strict FDA electronic record and signature requirements for data integrity.

Energy Efficient Operation: Optimized airflow design reduces energy consumption by 20% during eight-hour continuous operation.

Real-time Door Monitoring: Continuously monitors door opening status and airtight seal to ensure sterile integrity.