The sterile manual filling isolator can be fully customized according to the user's process requirements, implementing modular assembly to improve the production efficiency of sterile preparations.
Purification: Provide a continuously controllable A-class enclosed environment
Sterilization: using hydrogen peroxide (VHPS)®)Quick dye removal technology, no residue
Delivery: With RTP and other various input and output technologies, it achieves secure delivery of packaging materials, products, and tools;
Liquid transportation: Using sterile hose through wall technology specifically designed for isolators to achieve sterile connections from the outside to the inside; Continuous sterile drainage to ensure no contamination of the internal environment;
Monitoring: Real time monitoring of parameters such as wind speed, pressure difference, temperature, humidity, particles, and planktonic bacteria can be achieved under dynamic conditions;
Temperature control: The temperature inside the isolator can be adjusted to low temperature (2-8 ℃) and room temperature (18-26 ℃) according to product and process requirements, ensuring no impact on product stability;
The sterilization cycle parameters and operational process data can be exported and printed.
To meet the process requirements of sterile and highly toxic product production, BIBO safe replaceable high-efficiency filters can be installed on the return air duct to meet the requirements of toxicity sealing design.
Power Supply: AC 380V/50Hz
Control system: Adopting Siemens PLC control system, 12 inch Siemens industrial tablet computer
Airflow mode: Vertical unidirectional laminar flow
Cleanliness: GMP Grade A
Cabin airtightness: The hourly volume leakage rate of the cabin under test pressure (twice the working pressure) is less than 0.5%
Noise: The maximum working noise during system operation is less than 75dB (A)
Lighting: LED light sources are used for cabin lighting. Illuminance>300lx
Sterilization effect: kill 6 logarithms of thermophilic fat loving Bacillus with typical resistance
Hydrogen peroxide leakage rateThe leakage of hydrogen peroxide around the sterilization process isolator is less than 1ppm
Used to isolate and protect the key operational processes of aseptic filling and capping of formulations, in order to minimize the risk of external environmental pollution during the filling process and provide a smooth, standardized, and effective aseptic filling control process.
HTY-2000G8 Aseptic Filling Isolator, AFL-3S-G8 Aseptic Filling Isolator