400-9988-900
400-9988-900
The sterility testing isolator provides an aseptic environment for sterility test so as to better prevent microbial contamination of the sample to be tested, avoid contamination of test supplies and auxiliary equipment, and improve the accuracy of sterility test results.
Ø The equipment cavity is made of SUS316L stainless steel with a thickness of 3 mm, and the visual window is made of 15 mm tempered glass.
Ø The system conforms to the ergonomic design, cleanliness is ISO 4.8, and a full set of 4q verification services is available.
Ø The isolator is integrated with the temperature and humidity monitoring system, differential pressure monitoring system, air speed monitoring system, hydrogen peroxide concentration monitoring system, and the particle and plankton monitoring system.
Ø The isolator can detect the leak rate online (the pressure attenuation method), which meets the data requirements of ISO 10648, ISO 14644 and PDA TR34.
Ø The system design meets the GMP, ISO, ISPE, pharmacopoeia and other relevant requirements and complies with 21CFR Part11, and the product has passed the EU CE certification.
Ø Sterility testers can be configured according to process requirements.
Ø A WIP system can be configured according to process requirements to complete cabin cleaning, pipeline spraying and drying online.
Ø An online weighing balance can be configured according to process requirements, and the data can be integrated with the system or kept independent.
Ø RTP valve, waste bin, passing cart, and storage rack can be configured according to process requirements.
|
Cleanliness level |
Leak rate |
Sterility assurance level |
Noise |
Illuminance |
Differential pressure range |
Fissure air speed |
|
Grade A |
0.5% |
SAL≤10-6 |
≤65dB |
≥500lux |
-0pa~+ 80Pa |
≥0.5m/s |
TEL：86-731-87938293
E-mail：marketing@truking.com
ADD：No.1 Xinkang Road,Yutan Town,Ningxiang,
Changsha,China
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