Containment Isolation System
The role of the solid preparation containment isolation system:
■ Protect the drug from cross-contamination or external environment influence during the production process;
■ Protect personnel from occupational hazards of high activity, high sensitization and toxic substances (e.g penicillin, cytotoxins, hormones, anti-tumor, radiopharmaceuticals, etc.);
■ Protect the environment from highly active, highly sensitizing and toxic substances that are transmitted under uncontrolled conditions.
System Features
■ Occupational Exposure Band (OEB) 3-5■ Purification Level C\D
■ Fully customized, equipment selection according to process
Features of oral solid dosage containment isolation system
The high containment isolation system by Nano is specially designed to meet user's process and isolation protection level requirements It includes high shear granulator, cone mill, fluid bed granulator, lab blender, and high-efficiency coating machine. The system is used for production and processing of highly toxic and active drugs. It provides reliable protection for the safety and health of operators
The system includes air filtration system, and material transfer devices, an isolation chamber, processing machines gloves for personnel operation, and a control system. The chamber also has positive or negative pressure options and can be integrated with cleaning and disinfection systems. The system has a remote control function and allows for RTP transmission for fast isolated transmission. Sampling is performed by the operator with gloves at each operation step, and the sample is sealed and transferred through RTP
Typical operation process of solid dosage preparation containment isolation system
1 Start the filtration device to conduct self-cleaning and sealing performance tests on the internal environment of the isolation chamber
2. The material is transferred into the isolation chamber via RTP
3. The material can be transferred under negative pressure or fed into the granulation system by operator with gloves for granulation, drying and milling
4. The granules after being milled are mixed by the operator with gloves into the mixing device. After the mixing is completed, the granules are discharged to the designated closed container
5. Transfer the mixed material to the tablet or capsule filling compartment through RTP for tableting or capsule filling
6. Transfer the tablets through RTP to the coating isolation chamber for coating
7. Transfer the coated tablets or capsules to the packaging equipment isolation chamber through RTP for packaging
8. After the production is finished, the equipment and the isolation chamber are cleaned and disinfected, and the cleaning solution is discharged into the designated device
The sampling of each operation step is performed by the operator with gloves, and the sample is sealed and transferred through RTP.
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