Autoclave unloading isolator for sterile assembly
In pharmaceutical and biotech industries, preserving sterility during the unloading process from autoclaves is critical. Contamination risks arise when assembling sterilized items, necessitating a controlled and sterile workspace to maintain product safety and compliance with stringent regulatory standards.
Ensures aseptic environment during unloading
The Autoclave Unloading Isolator by Truking is designed to connect directly to sterilization cabinets, creating an aseptic environment for assembling sterilized articles and preventing microbial contamination. This isolator is made from SUS316L stainless steel with a 3 mm thickness, and features a 15 mm tempered glass visual window for safety and durability. It boasts a comprehensive monitoring system, including temperature, humidity, differential pressure, air speed, hydrogen peroxide concentration, and particle and plankton monitoring. The design ensures compliance with GMP, ISO, ISPE, and pharmacopoeia standards, and conforms to 21CFR Part11, having achieved EU CE certification. The isolator’s online leak rate detection meets ISO 10648, ISO 14644, and PDA TR34 data requirements. Additionally, it supports RTP valves configuration tailored to process needs.
Benefits
- Maintains a sterile environment for product assembly
- Comprehensive monitoring for critical sterilization parameters
- Compliance with global pharmaceutical standards
- Durable materials ensure long-term use and safety
- Online leak detection for continuous assurance