TL-GZ-MISG8 Aseptic Production Isolator
2026-1-9
TL-GZ-MISG8 Aseptic Production Isolator
Advanced three-chamber design, providing a continuously controllable dynamic Class A clean environment to meet the high standards of aseptic filling production.
Introduction
Innovative Three-Chamber Design
The TELING aseptic filling isolator adopts a three-chamber design, consisting of a transfer chamber, filling chamber, and crimping chamber, and is equipped with an integrated hydrogen peroxide generator to meet the requirements for simultaneous or separate sterilization of the three chambers.
High Customization and Automation
The TELING aseptic filling isolator can be fully customized according to the user's process requirements, implements modular assembly, and achieves automated production, greatly improving the efficiency of aseptic preparation production. It can also address contamination risks during the filling process of aseptic preparations and ATMP drugs.
Application Areas
Used for the isolation protection of key operations in the aseptic filling, stoppering, and crimping processes of preparations, to minimize the risk of external environmental pollution during filling operations, providing a smooth, standardized, and effective aseptic filling control process.
Product Features
Continuously Controllable Class A Clean Environment
Provides a continuously controllable dynamic Class A clean environment, ensuring the production environment remains controlled.
Fully Enclosed Physical Barrier
Provides a fully enclosed physical barrier, avoiding direct contact between operators and products, solving microbial contamination issues.
Real-time Environmental Monitoring
Can monitor settling bacteria, temperature, humidity, pressure, and wind speed in the environment in real-time, ensuring the production environment remains controlled.
Multi-functional Interface Configuration
All chambers of the isolator are pre-equipped with multi-functional interfaces, which can be configured with online floating bacteria and dust particle collection/detection equipment, and have in-situ sterilization capability.
Integrated Control and Compliance
Integrated control of the isolator and filling machine by an industrial computer, featuring multi-level login permission control, audit trail, and electronic signature functions, complying with FDA CFR21 PART11 regulations.
Full-process Data Traceability
The entire filling production process can be recorded, data is traceable, ensuring production compliance.
Automation and Intelligence
Automated and intelligent operation, reducing labor costs and improving production efficiency.
Advanced VHP Sterilization Technology
Integrates the latest generation Vaporized Hydrogen Peroxide (VHP) sterilizer developed by TELING with precise hydrogen peroxide gas concentration/saturation control technology, enabling rapid sterilization of the chamber environment.
Flexible Chamber Sterilization Options
Chambers can be sterilized together or each chamber can be sterilized separately, providing flexible production scheduling.
Cost Advantage: Using the TELING aseptic filling isolator can shorten project construction cycles and reduce operating costs; it can be placed in lower cleanliness environments (Class D), reducing operating costs; it can provide solutions for clean rooms with limited space.
Optional Configurations and Functions
Compliance Standards
The TELING aseptic filling isolator fully complies with the following international standards and specifications:
Design and Operational Advantages
Ergonomic Design
More ergonomic design, improving operational comfort and efficiency.
New Human-Machine Display Interface
Intuitive operation interface, simplifying operational procedures.
Front Top-Opening Window Design
Aseptic inflatable seal, equipped with safety lock, ensuring operational safety.
Integrated Glove Leak Testing System
Ensures the integrity and sealing of the isolator.
Easy Installation of Other Equipment
Facilitates the installation of other production equipment in the isolator, improving system compatibility.
Spacious Internal Operation Space
Provides ample operating space, improving work efficiency.
On-site Splice Assembly
Can be spliced and assembled on-site, facilitating installation and relocation.
Hefei Tailing Biotechnology Co., Ltd Copyright 皖ICP备2021001288号-2 {Disclaimers}