AFL series sterile filling workstation

application field

Used to isolate and protect the key operational processes of aseptic filling, plugging, and capping of formulations, in order to minimize the risk of external environmental contamination during the filling process and provide a smooth, standardized, and effective aseptic filling control process.

Core Features

1. Aseptic assurance:The AFL series isolators ensure the highest air quality in isolated environments, thanks to:
– The engineering filtration system consists of H14 high-efficiency particulate air (HEPA) filters.
–The latest generation of VHPS developed by Integrated Tailin ®） Sterilizers and precise gas concentration/saturation control technology,Quickly sterilize the cabin environment to ensure a sterile environment during the sampling process.

Inflatable seals made of silicone approved by GMP ensure the sealing of the cabin.

–Fully enclosed physical barriers prevent direct contact between operators and products, solving the problem of microbial contamination.

–Real time monitoring of settling bacteria, temperature, humidity, pressure, and wind speed in the chamber to ensure continuous control of the production environment.

2. Automatic leak testing:The AFL series isolators are equipped with a conventional automatic leak testing system, which performs individual leak tests on each chamber according to the pressure change method described in the international standard ISO 10648-2,Under 2 times the test pressure, the hourly volume leakage rate is less than 0.5%.

3. Glove integrity test:The AFL series isolators are equipped with integratedThe automatic glove leakage testing system (GIT series) performs independent leakage testing on each glove installed on the isolator system according to the positive pressure attenuation method described in the international standard ISO 14644-7. Detect pores as small as 300 μ m in diameter.

4. Data management:AFL series data management systemIntegrated control of isolators by industrial computers.– It has multi-level login permission control, audit tracking, and electronic signature functions, in compliance with the relevant regulations of FDA 21 CFR Part 11.

– The entire filling production process can be recorded with traceable data.

5. Ergonomic design:The excellent ergonomic design of the AFL series isolators ensures that operators receive good working conditions. Maximizing operator efficiency and minimizing accident risks, eliminating unplanned downtime, and improving production quality.

6. Energy saving:Thanks to the sterile assurance capability of the AFL series isolators, the equipment can be placed in lower clean environments (D-level) to reduce operating costs; At the same time, the new sustainable low-voltage variable frequency ventilation fan and isolator have very low energy consumption throughout their entire operating cycle.

7. Easy to maintain:The integrated control module made of AISI 304 stainless steel allows direct access to all maintenance operations. Allow secure and private communication through the Internet network, and remotely access assistance, updates, and maintenance anytime, anywhere.

8. Customized design:The AFL series isolator is a custom designed sterile processing isolator system that can be composed of multiple modules.

– For particles with radioactivity, toxicity, and bacteria, a non-contact and safe replacement bag in bag out filtration system (optional) can be provided;

– DPTE Material Rapid Transfer System (optional)

– Aseptic liquid through wall system (optional);

– Efficient VHP catalytic decomposition device, achieving lower safe discharge concentration (optional);

– An efficient VHP catalytic internal decomposition device can provide a decomposition device that can quickly reach 1ppm and safely discharge into the background environment of the isolator (optional).