Modular Aseptic Testing Isolator
2026-1-9
The TL-MIS series is an advanced modular sterile testing isolation system designed specifically for laboratory professionals who require sterile testing of pharmaceutical products under strict sterile conditions. The system combines physical barriers with VHPS (Vaporized Hydrogen Peroxide Sterilization) technology to create a sustained and stable GMP A-level clean environment, effectively reducing the risks of external and cross contamination.
TL-MIS Series Modular Sterile Testing Isolator
Modular solution specifically designed for pharmaceutical product sterile testing laboratories, providing continuous, professional GMP Grade A clean environment
Product Overview
The TL-MIS series is an advanced modular sterile testing isolation system specifically designed for laboratory professionals who need to perform pharmaceutical product sterile testing under strict aseptic conditions. The system combines physical barriers with VHPS (Vaporized Hydrogen Peroxide Sterilization) technology to create a continuous, stable GMP Grade A clean environment, effectively reducing the risk of exogenous contamination and cross-contamination. [1,7](@ref)
The TL-MIS series adopts a highly modular design concept, allowing flexible configuration according to laboratory space and testing requirements, supporting "continuous" or "batch" operation modes, significantly improving sterile testing efficiency. The system integrates an intelligent control system with multi-level permission management, electronic signature, and audit trail functions, compliant with GMP and FDA computer system validation requirements. [1,7](@ref)
The system integrates a new generation of VHPS vaporized hydrogen peroxide sterilization technology, achieving controllable hydrogen peroxide concentration and saturation, significantly shortening the sterilization time of transfer chambers and operation chambers. Under ideal conditions, the sterilization time of the experimental chamber can be reduced by 40%, and the sterilization time of the transfer chamber can be shortened to one-third of traditional methods, achieving a Log6 reduction against Geobacillus stearothermophilus, ensuring the professionalism and reproducibility of the sterile environment. [1,4,6](@ref)
Core Features
Modular Design
Adopts a highly modular design with functional modules that can be independently configured and flexibly combined, easily adapting to different laboratory spaces and testing requirements. Supports quick disassembly and transportation, significantly shortening equipment deployment cycles. [1,7](@ref)
VHPS Rapid Sterilization
Integrates a new generation vaporized hydrogen peroxide (VHPS) sterilization system with significantly shortened sterilization time, controllable hydrogen peroxide concentration and saturation, strictly controlling condensation, ensuring the reproducibility of sterilization effects. [1,4,6](@ref)
Intelligent Control
Equipped with an advanced industrial control management system featuring multi-level permission management, electronic signatures, and audit trail functions, compliant with GMP and FDA computer system validation requirements, achieving digital management of testing processes. [1,7](@ref)
Ergonomic Optimization
Optimized operation panel tilt angle, light source, and height design, allowing operators to work comfortably whether standing or sitting, reducing fatigue during prolonged operation, and improving work efficiency. [1,7](@ref)
Optimized Airflow Model
Optimizes airflow organization through CFD simulation analysis, achieving dead space-free vertical laminar flow, uniform air distribution within the chamber, preventing pollutant retention, and improving cleanliness stability. [1,4,6](@ref)
Energy-saving and Eco-friendly Design
Newly designed air handling unit reduces room fresh air demand and air conditioning system energy consumption, optional internal circulation catalytic decomposition module, reducing operating costs, conforming to green laboratory concepts. [1,7](@ref)
Technical Specifications
| Cleanliness Level | ISO Grade 5 (GMP Grade A) [1,7](@ref) |
|---|---|
| Airflow Pattern | Vertical laminar flow (optional turbulent flow) [1,4](@ref) |
| HEPA Filter | H14 grade efficiency filter (optional ULPA filter) [1,7](@ref) |
| Sterilization Method | VHPS Vaporized Hydrogen Peroxide (optional dry fog hydrogen peroxide) [1,4,6](@ref) |
| Sterilization Effect | Log6 reduction against Geobacillus stearothermophilus [1,4,6](@ref) |
| Sterilization Time | Experimental chamber: 40-60 minutes (rapid mode: 20-30 minutes) [1,4](@ref) |
| Glove Configuration | 2-6 glove ports (customizable glove quantity and layout) [1,7](@ref) |
| Control Interface | Touchscreen control panel (optional remote monitoring system) [1,4,6](@ref) |
| Power Requirements | 380V±10%, 50Hz (optional other voltage configurations) [1,7](@ref) |
| External Dimensions | Customizable according to customer requirements (standard width: 1200-2000mm) [1,7](@ref) |
Application Areas
The TL-MIS series modular sterile testing isolator is widely used in the following areas: [1,3,4,5,6,8,9](@ref)
- Pharmaceutical Sterile Testing - Sterility check of sterile drugs such as antibiotics and vaccines
- Medical Device Testing - Sterility performance verification of implantable medical devices like cardiac stents and artificial joints
- Biotechnology Research - Provides aseptic environment assurance for high-precision operations like gene editing and cell therapy
- Active Pharmaceutical Ingredient Production - Sterility assurance and testing of sterile API production environments
- Cell Therapy Products - Cell preparation isolator provides closed aseptic space for cell operations
- Genetic Engineering Products - Prevents contamination by exogenous factors, ensuring genetic product quality
- Biological Preparation Filling - Aseptic isolation system ensures aseptic conditions during the filling process
- Rapid Microbial Detection - Supports rapid microbial detection methods, shortening detection cycles
Pharmaceutical Industry Applications
The TL-MIS series is widely used in various aspects of the pharmaceutical industry including sterile API production, formulation workshops, and vaccine production, ensuring drug production complies with GMP requirements. The system supports both membrane filtration and direct inoculation methods, meeting the requirements of domestic and international pharmacopoeias. [1,3,4,5](@ref)
Biotechnology Applications
In the biotechnology field, TL-MIS provides a safe and professional aseptic operation platform for high-precision operations such as gene editing and cell therapy, preventing contamination by exogenous factors, and ensuring aseptic conditions throughout the biological product production process. [1,3,5,6](@ref)
Medical Device Applications
Used for sterility performance verification of implantable medical devices such as cardiac stents and artificial joints, ensuring the safety and effectiveness of medical device products, meeting relevant regulatory requirements. [1,3,4,5](@ref)
Research Institution Applications
Provides a safe and professional experimental environment for teaching and research activities in universities and research institutions, supporting the aseptic operation needs of various cutting-edge biotechnology research projects. [1,3,5,6](@ref)
Compliance and Certifications
The TL-Mis series strictly follows domestic and international pharmaceutical production quality management regulations and related technical standards: [1,4,6,7,8](@ref)
The TL-MIS series sterile testing isolator fully complies with international pharmaceutical production quality management regulations such as China GMP, FDA cGMP, and EU GMP, meeting the testing requirements of mainstream global pharmacopoeias including Chinese Pharmacopoeia, USP, EP, and JP, ensuring global recognition of testing data. [1,4,6,7,8](@ref)
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