The sterile automatic filling isolator can be customized according to the user's process requirements, integrating world-class filling equipment, implementing modular assembly, realizing automated production, and greatly improving the efficiency of sterile formulation production.

Purification: Provide a continuously controllable A-class enclosed environment

Sterilization: using hydrogen peroxide (VHPS)^®）Quick dye removal technology, no residue

Delivery: Equipped with various input and output technologies such as RTP, it enables 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.

Power Supply: AC 380V/50Hz

Control system: using Siemens PLC control system and 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%

Biological decontamination method: Vaporized hydrogen peroxide (VHPS) sterilization

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: The 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.

Provide a complete set of verification documents that meet FDA and EMA audit requirements, and conduct testing.

HTY-2000G8 aseptic filling isolator, AFL-3D-G18 aseptic filling isolator, etc