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TL-MIS1650C Sterility Testing Isolator

2026-1-9

Advanced design concepts, reliable performance, meeting the highest standards for sterile production
TL-MIS1650C无菌检测隔离器
TL Series Aseptic Isolator | Product Details

Product Overview

The TL series aseptic isolator adopts advanced isolation technology, providing a continuously controllable clean environment for aseptic operations. The equipment combines the latest design concepts and technological innovations, ensuring the safety and professionalism of the production process.

Cleanliness Class
Class A (ISO 5)
Sterilization Method
VHP (Vaporized Hydrogen Peroxide)
Control Method
PLC + Touch Screen
Certification Standards
GMP/FDA

Key Features

Professional Sealing Performance

Uses special sealing design and materials, ensuring equipment leakage rate below 0.5%/h, effectively maintaining internal aseptic environment and preventing cross-contamination.

Advanced Sterilization System

Integrates an efficient Vaporized Hydrogen Peroxide (VHP) sterilization system, achieving sterilization efficacy up to Log6 biological indicator kill rate, meeting aseptic production requirements.

Intelligent Control System

Adopts PLC + touch screen control, featuring multi-level permission management, audit trail functions, complying with FDA 21 CFR Part 11 regulations.

Modular Design

Employs modular design concept, can be flexibly configured according to customer requirements, supports on-site splicing installation, facilitating transportation and layout adjustments.

Real-time Environmental Monitoring

Can monitor and record key parameters in real-time, including temperature, humidity, pressure difference, wind speed, airborne particles, and viable particles, with traceable data.

Ergonomic Optimization

Operation interface and glove port positions are ergonomically optimized, reducing operator fatigue, improving work efficiency and comfort.

Application Scenarios

The TL series aseptic isolator is widely used in the following fields:

Aseptic Filling Processes
Aseptic Sampling Operations
Aseptic Testing Environments
Cell Therapy Product Preparation
Aseptic Powder Handling
Aseptic Material Transfer
Lyophilization Process Operations
Biological Preparation Production

Customization Service: Can be customized and configured according to specific customer process requirements, meeting special needs of different application scenarios.

Technical Advantages

Innovative Airflow Design

Adopts vertical unidirectional flow or horizontal unidirectional flow design, ensuring stable and uniform airflow in the working area, effectively preventing cross-contamination. Airflow distribution uniformity reaches industry-leading levels.

Intelligent Sterilization Management

Integrates intelligent sterilization management system, can set sterilization parameters according to different process requirements, automatically records sterilization process data, supports data export and traceability.

Efficient Filtration System

Equipped with HEPA/ULPA air filters, with filtration efficiency ≥99.99% for 0.3μm particles, ensuring the working area meets Class A cleanliness requirements.

Safety Protection Mechanisms

Multiple safety protection designs, including pressure difference alarms, door interlock, VHP concentration monitoring, temperature abnormality alarms, ensuring equipment and personnel safety.

Model Comparison

The TL series offers multiple models to meet different production needs:

Model Work Area Size (W×D×H) Suitable Operators Airflow Pattern Sterilization Time
TL-IS1200 1200×800×800mm Single Operator Vertical Unidirectional Flow Approximately 90 minutes
TL-IS1500 1500×800×800mm Dual Operators Vertical Unidirectional Flow Approximately 100 minutes
TL-IS1800 1800×900×800mm Dual Operators Horizontal Unidirectional Flow Approximately 120 minutes
TL-IS2400 2400×900×800mm Three Operators Horizontal Unidirectional Flow Approximately 150 minutes

Optional Configurations and Accessories

Online Particle Monitoring System
Online Viable Particle Sampler
VHP Concentration Real-time Monitoring
Glove Integrity Test System
Rapid Transfer Port (RTP)
Material In/Out Transfer System
Intelligent Dehumidification System
Video Monitoring System
Barcode/RFID Identification System
Remote Monitoring and Diagnostics

Note: The above configurations can be selected and combined according to specific customer requirements, providing comprehensive customized solutions.

Service and Support

Professional Validation Services

Provides complete IQ/OQ/PQ validation services, including sterilization efficacy validation, airflow pattern testing, leak testing, etc., ensuring equipment compliance with regulatory requirements.

Operation Training

Provides comprehensive operation training, including equipment operation, daily maintenance, troubleshooting, etc., ensuring operators can skillfully use the equipment.

Technical Support

Provides 7×24-hour technical support services, quick response to customer needs, solving various problems encountered during equipment use.

Spare Parts Supply

Genuine original spare parts supply, provides quick replacement services, ensuring continuous and stable equipment operation.