Aseptic sampling isolator

NegotiableUpdate on 02/13

Model

Nature of the Manufacturer: Producers

Product Category

Place of Origin

Online Consult

Overview

The use of isolation operation technology in the drug production process can minimize the impact of operators and greatly reduce the risk of microbial contamination of products in sterile production environments. Operations with high pollution risks should be carried out in isolators. The new generation AS series sterile sampling isolator developed by Tailin Biotechnology adopts a highly modular design to continuously improve production efficiency and speed. The design is more in line with ergonomics to meet customers' needs for sterile production environments.

Product Details

　　Application field

1. Pharmaceutical industry: Sampling of sterile raw materials;

2. Customization for other areas with demand.

　　Main functions

Used for clinical trials, sampling, weighing, and packaging of sterile, toxic, allergenic, and highly active materials in the pharmaceutical industry.

　　Aseptic sampling isolatorIt is a custom designed cGMP Class A/ISO 5 isolator system specifically designed for handling sampling of large containers/bags and sterile powders (API).

　　Core Features

　　1. Aseptic assurance:The AS 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 AS 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 AS 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:The AS series data management system is integrated and controlled by an industrial computer for isolators, with multi-level login permission control, audit tracking, and electronic signature functions, in compliance with the relevant provisions of FDA 21 CFR Part 11.

　　5. Ergonomic design:The excellent ergonomic design of the AS series isolators ensures good working conditions for operators. 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 AS series isolators, the equipment can be placed in lower clean environments (Class D) 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 AS series isolator is a custom designed sterile processing isolator system that can be composed of multiple modules.

The standard sampling isolator configuration consists of a 2-glove working chamber and a 4-glove transfer capping chamber. This makes the AS series isolators very suitable for various sampling needs.

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

- 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).