- Phone
-
Address
Building A15, Sany Zhushengyuan, Zhengbo Road, Fengxian District, Shanghai
Xingdeke Taishida Pharmaceutical Technology (Shanghai) Co., Ltd
Building A15, Sany Zhushengyuan, Zhengbo Road, Fengxian District, Shanghai
The Taishida Pura 2, 3, and 4 sterile testing isolators are suitable for sterile testing of small batches of samples. Customers can choose the appropriate isolator model based on the number of testing batches. These isolators are used for single batch aseptic testing. The isolator is pre loaded with samples and testing materials before biological purification sterilization, and sterile testing is performed after sterilization. The isolator is then stopped to end the testing.
The Taishida Pura 3+and 4+sterile testing isolators are suitable for sterile testing of multiple batches of samples in a continuous manner. The isolator is pre loaded with initial test samples and materials before biological purification sterilization, and undergoes sterility testing after sterilization. This type of isolator is equipped with a transfer chamber, which can simultaneously load test samples and perform biological purification sterilization during sterile testing in the main testing chamber. The entire process of aseptic testing is continuous and uninterrupted. The test samples and materials can be safely transferred from the transfer chamber to the main testing chamber without affecting the sterility of the entire testing environment.
Main features and advantages:
•Positive pressure operating environment with alarm set points to avoid any product contamination
•Unidirectional turbulent flow(EU GMPlevelA)Maintain a sterile environment inside the isolator
•The front glass observation panel of the cabin is hinged pigeon wing type and can only be opened upwards and outwards. After opening, the equipped gas pillar will keep the door open
•All doors use inflatable seals to ensure a very low leakage rate, in compliance withISO 14644-7Strict in the middleThe leakage standard.
•.rightH202Due to its high tolerance, it will not cause excessive gas release, thus greatly shortening the biological purification cycle time
•Isolators can integrate different types of biological purification and sterilization systems to meet customer needs
•Integrated or separately configured external biological purification and sterilization systems, or using Taishida'sionHP+Biological purification and sterilization system
•based onPLCUser friendly automatic control system with automatic leak testing function (pressure holding test)
The main advantages of using sterile testing isolators
•There is no requirement for a clean room environment around the isolator
•No need to maintain and operate the surrounding clean room, reducing costs
•Reduce operating costs, no purification clothing requirements for technical personnel, no need for frequent cleaning and sterilization
•Exclude major sources of contamination from the testing area (operator)
•Significantly reduce the risk of false positive test results and the risk of product launch delays, as well as
Reduce the workload of duplicate investigations
•Significantly improve the efficiency of sample analysis
•More in line with domestic and regulatory requirements
•portability(Aseptic testing isolators can be easily moved to different testing locations)