The sterility testing isolator provides a sterile environment for the sterility test, which can better prevent the microorganism from contaminating the sample to be tested, avoid the contamination of test supplies and auxiliary equipment, and improve the accuracy of the sterility test results.
The device chamber is made of SUS316L stainless steel with a thickness of 3mm. The window can be made of 15mm toughened glass.
The system conforms to ergonomic design, the cleanliness is lSO 4.8, and a full set of 4Q verification service is provided;
Integrated 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 leakage rate online (pressure attenuation method), which meets the data requirements of lSO 10648, ISO14644 and PDA TR34.
The system design conforms to GMP,ISO, ISPE, pharmacopceia and other related requirements, and meets 21CFR Part 11. The product has passed the European CE certification.
According to the process requirements, can be equipped with sterility tester,
According to the process requirements,WlP system can be configured to complete in-cabin cleaning, pipeline spraying anddrying online:
According to the process requirements, can be configured online weighing balance, data can be integrated with the system orindependent;
According to the prcess requirements, can be equipped with RTP valve, trash can, deliveny cart, rack, etc.
