Kỹ Thuật
An Aseptic Isolator Cabinet, also known as a pharmaceutical isolator or sterile isolator, is a high-containment enclosure designed to ensure aseptic conditions during pharmaceutical and biotechnological production. This sealed unit provides a controlled environment by completely separating the internal workspace from the external atmosphere, significantly reducing the risk of microbial contamination.
These isolators are essential in applications requiring GMP-compliant sterile conditions, including sterile drug manufacturing, vaccine production, and advanced cell or gene therapy
The Isolator Cabinet operates using multiple layers of contamination control, ensuring consistent sterility throughout the process:
Sealed Physical Barrier: Rigid or flexible walls combined with built-in gloves allow manipulation of materials without direct exposure.
HEPA/ULPA Filtration: High-efficiency filters provide ultra-clean air, removing up to 99.995% of particles and microorganisms.
Positive or Negative Pressure Control: Maintains unidirectional airflow to prevent cross-contamination.
VHP Sterilization (Vaporized Hydrogen Peroxide): An automated decontamination system sterilizes internal surfaces before each operation cycle.
Real-Time Environmental Monitoring: Integrated sensors track pressure, temperature, humidity, and particle count for full process traceability and compliance.
A pharmaceutical-grade isolator cabinet includes the following standard features:
ISO 10648-2 certified airtight enclosure
HEPA/ULPA filters (efficiency ≥ 99.995%)
Stable pressure regulation system (customizable for positive or negative pressure)
Automated decontamination system (VHP, CIP, or SIP)
High-durability glove ports (easy replacement, ergonomic design)
Advanced monitoring system for all critical parameters
H₂O₂ Vaporizer for in-situ sterilization
Sensors for pressure, airborne particles, humidity, and temperature
UV sterilization lamps and anti-static trays
Rapid Transfer Ports (RTP), heat sealers, and data printers
Visual and audible alarm systems for error or contamination alerts
Aseptic isolators are widely adopted in sterile and high-risk environments, including:
Filling and packaging of sterile injectable drugs
Compounding of cytotoxic or hazardous drugs
Sterility testing and microbiological QC
Biological product processing and gene therapy
Vaccine development and aseptic compounding
By minimizing contamination risks, isolators help ensure product safety and regulatory compliance.
| Criteria | Aseptic Isolator Cabinet | Biosafety Cabinet (BSC) |
|---|---|---|
| Level of Containment | Fully sealed, complete isolation | Partially open with recirculating airflow |
| Work Environment | Closed, controlled with filtered air | Open front access, filtered air |
| Use Case | Sterile drug production, vaccine filling, etc. | Microbiological work, sample handling |
| Built-in Sterilization | Yes (VHP, SIP, or CIP systems) | No built-in sterilization |
| Cost | Higher (due to advanced containment features) | Lower (basic contamination control) |
Looking for a high-performance Aseptic Isolator Cabinet for your cleanroom or pharmaceutical production line? Get expert advice and competitive pricing from:
BACH LONG TECHNOLOGY CO., LTD
📍 Address: 75 Nguyen Hong Street, Ward 1, Go Vap District, Ho Chi Minh City
📞 Hotline: +84 93 143 54 54
📧 Email: sales@congnghelockhi.vn
🌐 Website: www.congnghelockhi.vn
