Active pharmaceutical ingredient isolation system
In the pharmaceutical industry, maintaining aseptic conditions during drug production is crucial to ensure product safety and efficacy while protecting personnel from exposure to toxic substances.
Ensures aseptic production with comprehensive monitoring
The Active Pharmaceutical Ingredient (API) isolator from Truking guarantees aseptic production while preventing exposure to harmful products. Made from SUS316L stainless steel and featuring a 15 mm tempered glass visual window, it meets GMP, ISO, and pharmacopoeia standards. The system integrates multiple monitoring systems for temperature, humidity, differential pressure, air speed, hydrogen peroxide concentration, glove grating, and particle and plankton levels. It complies with ISO 10648, ISO 14644, and PDA TR34 standards for leak detection. Additionally, it includes a WIP system for online cleaning, pipeline spraying, and drying. The isolator can be customized with RTP and α β separation butterfly valves, a nitrogen system for oxygen detection, and an explosion-proof configuration.
Benefits
- Ensures aseptic production
- Protects personnel from toxic exposure
- Comprehensive monitoring systems integrated
- Meets multiple regulatory standards
- Configurable for specific process requirements