Sartorius Stedim Biotech has developed the Sartocheck 4 Plus, the latest addition to the Sartocheck range of integrity testing systems.
Sartocheck is designed to make integrity testing, including the bubble point, diffusion or water intrusion test, fast and uncomplicated.
It is simple to operate and meets the technical requirements of the biopharmaceutical industry.
The Sartocheck 4 Plus is available with an optional scanner that enables important information to be read into the test unit.
This feature permits the Sartocheck 4 Plus to automatically capture data directly coded on the respective filter cartridges as data-matrix code, such as filter type, lot number and date of expiration.
This leads to error-free data transfer to the Sartocheck 4 Plus, according to the company.
Immediately after the data of a filter cartridge has been scanned in, the integrity test system automatically selects the right test program from its database, which is said to make the entire test process user friendly and efficient.
Fast test sequences and automatic timing for the intelligent acceleration of testing are among the additional features of the system.
The automatic detection of errors in the test equipment setup, such as a disconnected filter housing, enhances the reliability of integrity test results.
Units additionally connected to the Sartocheck 4 Plus, called Multiunits, enable users to run independent as well as time- and cost-saving parallel tests of up to five filters.
The patented cleaning function of the integrity test system enables the sanitisation of the internal pneumatic components, even after aggressive cleaning agents have been used.
The Sartocheck 4 Plus has been designed according to the GAMP guidelines and complies with 21 CFR Part 11 requirements.
This unit offers a choice of electronic data transfer options, such as PDF files, network connectivity, Profibus and SD cards and can be completely interfaced with the appropriate process control systems for the automatic control of integrity testing.