Turbulent flow pvc isolator testing with pre-chamber for beverage factory

Product description

A sterile inspection isolator is an air purification product that separates an operator from a laboratory or a powder or liquid product in a production process by a physical barrier. The isolator system creates a local Class A environment in a low-level background environment. In the biopharmaceutical industry, the physical isolation of products and personnel is a key factor, and the design and application of the isolator depends on the nature of the isolator. According to the characteristics of use, the internal and external pressure difference of the isolator, airflow, construction materials, environment, type Wait. Depending on the application of the isolator system, it can usually be designed as a positive pressure isolator and a negative pressure isolator; the seal of the pattern isolator can usually be designed as a fully sealed isolator (Isolator) and a restricted access isolation system (RABS), while limiting access. The isolation system (RABS) can be further divided into an open restricted access isolation system (O-RABS) and a closed restricted access isolation system (C-RABS).

The winteam sterility check isolator is a vertically unidirectional, air-purifying device that provides a local class A environment and separates human and machine; it is widely used in the pharmaceutical industry to create Class A irrigation in the context of Class B clean environments. Install the assembly line environment.

The winteam sterility check isolator uses a physical barrier to isolate the controlled space from the external environment and is safely operated through the cuff opening for an absolute isolation. At the same time, the vaporized hydrogen peroxide sterilization technology (VHP) is used to effectively kill microorganisms on the surface of the objects in the confined space, and the air in the confined space and the exposed surface can reach 6-log.

1. The first generation: soft materials such as PVC as the main structural material, the air treatment system is designed as a turbulent structure; the operating parts are mainly gloves/sleeve components, half-length suits, and controlled by ozone or peracetic acid. The mainstream means of microbes.
2. The second generation: With the development of aseptic isolation technology and sterilization technology, the aseptic isolator developed into a stainless steel material as the main structural material, but the structure still retains the turbulent flow design in the cabin. The sterilization method is mainly based on a hydrogen peroxide device connected to an external vaporization or spray.
3. The third generation: In order to strengthen the risk control during the use of the sterile isolator and based on the occupational health considerations of the operators, the aseptic isolator develops into a stainless steel-based material, a unidirectional flow design, an integrated online environmental monitoring device, and vaporization. The hydrogen peroxide sterilization system is integrated with the isolator. With electronic signature and electronic record requirements, it achieves regulatory requirements for data integrity such as disaster recovery and audit trails.

Parameter

Brief description of the work process

Dehumidification - circulates the air in the isolator through the dehumidification device, reducing the relative humidity in the isolator, making VHP the most efficient;

Sterilization - input hydrogen peroxide vapor and maintain the desired concentration in the isolator, keep the VHP concentration above 700PPM, and keep the sterilization time for more than 30min;

In addition to the residual - stop the input of hydrogen peroxide gas, switch the sterilization system to the residual system, so that the hydrogen peroxide gas in the isolator is circulated through the catalyst to decompose, reduce the hydrogen peroxide concentration below 10PPM, and then through ventilation The residual value is not more than 1 ppm.

Check the working status - the system switches to the clean maintenance state, according to the set working wind speed and the positive pressure in the cabin, automatically adjust the air supply volume, return air volume, fresh air volume, maintain the cabin cleanliness and positive pressure state, and online To detect the cleanliness of the work area, you can also manually start the sampling of the floating bacteria.