System Integrity Tester

Used for testing the integrity of disposable systems (SUS) during the processing of raw materials and drugs in disposable liquid storage bags, disposable bioreactors, cell factories, etc.

Technical advantages

·Embedded computer system, Windows operating system is intuitive and reliable, and the testing process curve is displayed clearly and distinctly

·Using the classic pressure attenuation method for testing, integrity testing can be conducted on disposable systems before or after use

·Constrained and unconstrained devices can be selected for testing, and users can easily replace them, minimizing user expenses while meeting a wider range of sample requirements

·Single or two testing stations can be selected for testing, with high testing efficiency

·Each testing station can work independently and perform testing on disposable systems of the same or different specifications, with separate test results provided

·You can choose to manually input or use a barcode scanner for information input, which is convenient and secure

·Adopting top brand vacuum controlled components to ensure high testing accuracy

·It has sufficient password protection function, divided into four levels of permission management, and each operator has unique

·Login name and password combination are required to enter instrument operation

Unlimited storage for user count, unlimited storage for test data

·A comprehensive audit tracking system that meets FDA, 21CFR, and PART11 electronic record and electronic signature requirements

·Local data storage, automatic processing, and statistical testing data functions that meet GMP requirements, and cannot be

Export modified and deleted formats to ensure the permanent preservation of test results

·The instrument is equipped with R232 serial port and USB interface, supports data LAN transmission, and has ISP online upgrade function to meet customers' personalized requirements 

Technical Parameter

Range: 0-10Kpa

Test accuracy: Level 1

Pressure resolution: 0.001kPa

Testing station  ：2 test stations

Test capacity range    0.5-3000L

Detection limit     20μm

Single test time      20min/2 piece

Equipment operation: Comes with HMI

Gas source pressure: 0.4-0.7Mpa

Detection principle: pressure attenuation method

Host size 540mmX360mm X310mm (length, width, height)

Weight 24Kg

Environmental requirements

Environmental temperature 15 ℃ -35 ℃

Relative humidity up to 80%, no condensation

Working power supply 220V

Execution standards

2023版GMP、ASTM F2095 Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates

Configure

Host, barcode scanner, laser printer, test connector