Sterile Isolator
- Wonsen
- China
- 60
- Always Available
It is primarily used in aseptic pharmaceutical processes such as sterile drug filling, sterility testing, and aseptic preparation dispensing. Additionally, it is suitable for housing SPF (Specific Pathogen-Free) animals, as well as for various aseptic testing tasks, including pharmaceutical sterility testing, microbial limit testing, and sterility validation trials.
Application
It is mainly applied to sterile pharmaceutical processes such as filling of sterile drugs, sterile inspection, and re-packaging of sterile preparations. At the same time, it can also be used for the breeding of SPF (specifically pathogen-free) animals without specific pathogens, as well as for sterile testing of drugs, microbial limit detection, and sterile verification experiments and other sterile detection tasks.
Features
1. Cleanliness and Airflow: Internal cleanliness level A (ISO 5 grade); Core operations adopt unidirectional laminar flow, with wind speed ranging from 0.36 to 0.54 m/s; Sterile inspection conditions are turbulent, with air changes not less than 15 to 20 times per hour;
2. Sealing performance: Hourly leakage rate ≤ 0.5%; The airtightness meets the GMP requirements for aseptic isolation.
3. Pressure Regulation: Adjustable pressure range - 80Pa to +80Pa. It can switch between positive and negative pressure conditions.
4. Sterilization performance: VHP sterilization is adopted, achieving a 6-log spore-killing rate; the residual VHP concentration in the cabin after sterilization is less than 1 ppm, which does not affect the testing and ensures the safety of personnel.
