Pharmaceutical isolator system for aseptic production
In the pharmaceutical industry, ensuring the sterility of drug production lines is crucial for both product safety and worker protection. Handling toxic substances and maintaining an aseptic environment demands reliable containment solutions.
Ensures safe and sterile drug production environments
The Combined Production Isolation System from Truking is designed to guarantee aseptic manufacturing of pharmaceuticals while safeguarding operators from toxic compounds. Configurable with water injection, powder injection, pre-filled syringe, and other production lines, the isolation system achieves sterility assurance levels of SAL not greater than 10-6 thanks to its integrated gasified hydrogen peroxide sterilization. Constructed with 3 mm thick SUS316L stainless steel chambers and 15 mm tempered glass windows, it meets ISO 4.8 cleanliness standards and offers comprehensive monitoring systems for temperature, humidity, differential pressure, airspeed, hydrogen peroxide concentration, glove grating, particles, and plankton. Additionally, the system conforms to GMP, ISO, ISPE standards and meets 21 CFR Part 11 with EU CE certification. Optional WIP systems enhance cleaning efficiency, while RTP valves and a vertical rubber stopper cleaning machine can be configured as per process requirements.
Benefits
- Provides aseptic production environment
- Comprehensive monitoring systems for various parameters
- Meets multiple international regulatory standards
- High-quality construction materials for durability
- Configurable options for enhanced process customization