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Turbulent Flow Ss316 Sterility Test Isolator Usp In Pharmaceutical Industry

Categories Sterility Test Isolator
Brand Name: WINTEAM
Model Number: YT
Certification: ISO9001
Place of Origin: CHINA
MOQ: 1 set
Price: Negotiable
Supply Ability: 10set one month
Delivery Time: 30work days
Packaging Details: wooden case
cover: SS304 SS316 pvc
control: PLC
reduction: log 6
class: Laminar flow Turbulent flow
humidity resolution: 0.10%
External dimension: 2050*750*2200mm
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Turbulent Flow Ss316 Sterility Test Isolator Usp In Pharmaceutical Industry


Turbulent flow ss316 sterility test usp with pre-chamberf or Pharmaceutical factory


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;


Parameter

modelYT-N1200AYT-N1500AYT-N1800A
size2000*800*20002300*800*20002600*800*2000
size of operation1200*650*8501500*650*8501800*650*850
Air lock chamber size750*650*850
Power supplyAC220V 50Hz
Power800W
Operation portsingle side 2+1single side 3+1single side 4+1
Operating port size240mm diameter
Airflow modeengineering turbulence
Maximum ventilation75m3/h
High efficiency filter99.98% H13
Pressure control-99Pa~0Pa
Operating port protection wind speed0.5m / s (refer to ISO 14644-7)
Hour leak rate≤0.5% (refer to ISO 14644-7)

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


Quality Turbulent Flow Ss316 Sterility Test Isolator Usp In Pharmaceutical Industry for sale
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