Sterile Isolator with BIBO System
A sterile isolator is a completely sealed chamber that creates and maintains an ISO-standard sterile environment inside through highly efficient technical means such as HEPA/ULPA filtration and automated VHP sterilization. It serves as a physical barrier, completely isolating the product/experiment process from operators and the external environment, thereby providing the highest level of product and personnel protection.
BIBO (bag in-bag out) is a sealed system used for safely replacing the high-efficiency filters (HEPA/ULPA) in isolators. It looks like an interface with a retractable frame and a sealed bag. The high-efficiency filters need to be replaced when their service life expires or they are accidentally damaged. The filter surface may retain high concentrations of pathogenic microorganisms or highly active product powders.
The BIBO system enables operators to replace the filters without coming into contact with contaminants or allowing contaminants to leak into the environment. The entire process takes place in a sealed bag, perfectly protecting operators and the environment. During the replacement process, the sterile state inside the isolator is not disrupted, significantly reducing production downtime.
The fan is the core component that maintains a stable pressure difference between the interior and exterior of the isolator. For aseptic operations, a positive pressure (internal pressure > external pressure) is typically maintained to prevent the entry of bacteria-laden air from the outside. The fan continuously circulates the air, which passes through the HEPA/ULPA filter at the top to form a uniform unidirectional flow (laminar flow) that blows downward, carrying away particles and microorganisms and maintaining the cleanliness of the internal environment. The variable-frequency fan can automatically adjust its speed based on the opening and closing of the door to compensate for pressure loss, ensuring that air flows outward when the door is open and quickly restores the pressure difference and cleanliness after the door is closed.
Aseptic medicine production: Such as aseptic filling lines, liquid preparation systems, and isolation protection for the injection port of rubber stoppers/aluminum caps.
Cell and gene therapy: The manipulation of live organisms such as CAR-T cells requires the simultaneous protection of both the products and the operators.
Sterility testing: Used for sterility inspection experiments, it is a standard equipment in the laboratory.
Production of highly allergenic drugs: The isolator offers the best protection for personnel.
If you have more specific application scenarios or budget ranges, Suzhou Pharma Machinery can provide you with more targeted information.
Suzhou Pharma Machinery Co.,Ltd.
2025/09/01
Tia
