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Suzhou Incheon Clean Technology Co., Ltd.

Contact: Mr. Hu

Tel: 137 3264 8199

Contact: Mr. Wang

Tel: 180 1357 4420

Website: www.rcclean.com

Add: No. 99, Tongcheng Road, Weitang Town, Xiangcheng District, Suzhou

Sterility test isolator

Sterility test isolator

The sterility test isolator is a sealed system that provides a sterile environment for sterility test, which can better prevent microbial contamination of the sample to be tested and avoid contamination of test supplies and auxiliary equipment
  • Category:Biosafety protective equipment
  • Browse number:
  • Release time:2024-04-11 08:29:51
  • Product description

     Performance characteristics:

The chamber is made of SUS316L stainless steel, the thickness is 3mm, and the window is made of 15mm tempered glass.

The system meets the ergonomic design, the cleanliness is ISO 4.8, and provides a full set of 4Q verification services;

The isolator integrates temperature and humidity monitoring system, pressure difference monitoring system, wind speed monitoring system, hydrogen peroxide concentration monitoring system, particle and plankton monitoring system;

The isolator can detect the leakage rate online (pressure attenuation method) according to ISO 10648, ISO14644, PDA.


     Data requirements for TR34:

System design conforms to GMP, ISO, ISPE, pharmacopoeia and other relevant requirements;

According to process requirements, sterility tester can be configured;

According to the process requirements, the WIP system can be configured to complete the cabin cleaning, pipe spraying and drying online;

According to process requirements, online weighing balance can be configured, data can be integrated with the system or independent;

According to the process requirements, it can be configured with RTP valve, garbage can, transfer car, storage rack, etc.


 Technical parameters:

Cleanliness level: Class A (comply with GMP)

Sterility level: SAL≤10-6

Leakage rate: Q/V≤0.5%

Noise: ≤65dB

Illumination: ≥300LUX

Crack wind speed: ≥0.5m/s

Pressure difference range: 0-80Pa



 Applications:

Sterility test

Aseptic filling

Aseptic dispensing

Aseptic cell culture



 


 Product picture:

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