The Aseptic Filling Isolator is a custom designed cGMP Class A/ISO 5 environment isolator system, designed for batch pharmaceutical production of injectable products for preclinical and clinical trial studies. Aseptic Filling Isolator adopts a three chamber design, consisting of transfer chamber, filling chamber and capping chamber, and is equipped with integrated Vaporized Hydrogen Peroxide sterilization system to sterilize the chambers together or separately. It adopts modular assembly and automated production to improve the efficiency of aseptic preparation production.
| Air flow: Vertical unidirectional laminar flow | VH2O2 Leakage: <1ppm (around the isolator during sterilization) |
| Control System: Siemens PLC control, 12"Siemens industrial panel PC | Cleanliness Level: GMP Grade A |
| Killing Rate: ≥log6 | Noise:<75dB(A) |
| Power Supply: AC380V/50Hz | Lighting: LED lamp, 500lux |
| Airtightness: leakage rate is less than 0.5% volume/hour at 2 times working pressure | |
| *Customized according to user's requirements |
It is used to isolate and protect the critical processes of aseptic filling, corking and capping of preparations, minimising the risk of contamination from the external environment during the filling process.
Yes. The AFL Series is designed for customized and modular configuration to meet various process requirements:
The isolator ensures sterility through multiple integrated design elements:
Real time monitoring the sediment bacteria, velocity, differential pressure, humidity, temperature
Tailin provides comprehensive validation support and documentation packages, including:
