Aseptic filling workstation

NegotiableUpdate on 02/13

Model

Nature of the Manufacturer: Producers

Product Category

Place of Origin

Online Consult

Overview

The AFL series sterile filling workstation adopts a three compartment design, consisting of a transfer compartment, a filling compartment, and a capping compartment, and is equipped with an integrated hydrogen peroxide generator to meet the requirements of joint sterilization and individual sterilization of the three compartments. It can be customized according to the user's process requirements, implement modular assembly, achieve automated production, and greatly improve the efficiency of sterile formulation production. At the same time, it can solve the contamination risk during the filling process of sterile preparations and ATMP drugs.

Product Details

　　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. Aseptic filling isolator is a custom designed cGMP ClAFLs A/ISO 5 isolator system specifically designed for mass pharmaceutical production of injectable products for preclinical and clinical trial research. This specific AFL series isolator is designed to meet mandatory user requirements and is integrated with the Tailin automatic filling and capping machine.

　　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.

- Integrated with the latest generation of vaporized hydrogen peroxide (VHPS) developed by Tailin ®) Sterilizers and precise hydrogen peroxide gas concentration/saturation control technology are used to rapidly sterilize the cabin environment, ensuring a sterile environment during the sampling process.

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

- Fully enclosed physical barrier to 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 conducts individual leak tests on each chamber using the pressure change method described in the international standard ISO 10648-2. Under 2 times the test pressure, the hourly volume leak rate is less than 0.5%.

　　3. Glove integrity test:The AFL series isolators are equipped with an integrated automatic glove leakage testing system (GIT series), which 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: AFLThe series data management system integrates and controls the isolator through an industrial computer. - 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, 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);

- Efficient VHP catalytic internal decomposition device, capable of quickly achieving 1ppm decomposition and safely discharging into the background environment of the isolator (optional).