Turbulent Flow Ss316 Sterility Test Isolator Usp In Pharmaceutical Industry

Parameter

1. Multi-parameter monitoring system such as cabin temperature, relative humidity and pressure, supporting real-time printing, storage and other functions

2. Built-in weighing device can be built in, and the explosion-proof function can be customized. Comfortable operation, low noise, low operating energy

3. All functions with negative pressure isolators can be installed in Class D clean rooms or rooms without cleanliness

Fourth, built-in intelligent collection instrument

The new-generation sterilized inspection isolator is equipped with a new intelligent bacteria collection instrument, linear tube, automatic tube clamping, stepless speed regulation of the knob, pressure detection safety protection function, and the pressure can be automatically adjusted to the appropriate speed;

The isolation system is sealed or has a microbial filtration system (HEPA) that provides air and is self-cleaning. When confined, use only the purified interior surface or use the fast transfer channel for material transfer. When opened, material is only allowed to pass in and out through a specific, designed and verified opening to remove the transfer of contamination. It can be used to isolate active mixtures during aseptic processing or for both sterilization and isolation

The isolation system is sealed or has a microbial filtration system (HEPA) that provides air and is self-cleaning. When confined, use only the purified interior surface or use the fast transfer channel for material transfer. When opened, material is only allowed to pass in and out through a specific, designed and verified opening to remove the transfer of contamination. It can be used to isolate active mixtures during aseptic processing or for both sterilization and isolation

The aseptic isolation system is mainly used for sterility testing of products, which can effectively reduce or eliminate the false positive risk of sterility testing, and ensure the accuracy and authenticity of the sterility testing operating environment and test results. Compared to traditional sterile clean rooms, the isolation system is able to avoid personnel activities, so there is no potential for microbial contamination. The isolator solution simplifies the design of the QC laboratory and is installed in clean areas where no cleanliness is required, saving space and operating costs.

• Sterile laminar flow isolators are excellent sterile barriers that provide good environmental control for minimal false positive interference during aseptic processing. With advanced material transfer technology and biological decontamination methods, it can effectively reduce bioactive substance pollution up to 106. Depending on the process characteristics and requirements, special design systems and configurations are available to suit different batch and process flows. Through the configuration selection system determined by the end user, the operating state of the isolator can be changed to a positive pressure operation or a negative pressure operation mode, so that the system has versatility to meet the operational needs of sterile or positive bacteria detection.
• Hard hatch structure consisting of fully enclosed stainless steel and tempered glass;
• The cabin is welded integrally with 316L stainless steel, and all internal angles of the inner cavity are arc angles, which are convenient for cleaning and sterilization operations;
• Completely unidirectional airflow mode provides an exceptional aseptic operating area;
• The airflow mode is a vertical unidirectional airflow that quickly eliminates biofouling during ventilation;
• The material door is inflated and sealed, with pneumatic locking and working state interlocking function;
• Integrated or independent hydrogen peroxide sterilization can effectively reduce bioactive substance pollution up to 106;