Pharma Tips

Filter Integrity Testing - Operation & Feature

By: Pharma Tips | Views: 3160 | Date: 06-Mar-2012

When it comes to reliable and automatic integrity testing of membrane filter systems, the Sartocheck product family from Sartorius Stedim Biotech has been available for more than 30 years. Sartocheck makes integrity testing, such as the bubble point, diffusion or water intrusion test, fast and uncomplicated. It is easy to operate and meets the high technical requirements placed by the biopharmaceutical industry on advanced testing equipment.

Filter Integrity Testing

Sartorius Stedim Biotech: Sartocheck 4 plus



Filter Integrity Testing Sartorius 4 Plus


When it comes to reliable and automatic integrity testing of membrane filter systems, the Sartocheck product family from Sartorius Stedim Biotech has been available for more than 30 years. Sartocheck makes integrity testing, such as the bubble point, diffusion or water intrusion test, fast and uncomplicated. It is easy to operate and meets the high technical requirements placed by the biopharmaceutical industry on advanced testing equipment. The newly developed Sartocheck 4 plus, Sartorius Stedim Biotech has an optional scanner now that enables important information to be read into the test unit. What is unique about this feature is that it permits it to automatically capture all important data directly coded on the respective filter cartridges as data matrix code, such as filter type, lot number and date of expiration. This means convenient and error-free data transfer to the new device. Immediately after the data of a filter cartridge have been scanned in, the integrity test system automatically selects the right test program from its database, which makes the entire test process much more user-friendly and efficient.

Fast test sequences and automatic timing for intelligent acceleration of testing are among the additional features of the system. Automatic detection of errors in the test equipment set-up, such as a disconnected filter housing, considerably enhances the certainty and reliability of integrity test results. Units additionally connected to the Sartocheck 4 plus, called "MultiUnits," permit users to run independent as well as time- and cost-saving parallel tests of up to five different filters.
 
The patented cleaning function of the integrity test system enables reliable sanitization of the internal pneumatic components, even after aggressive cleaning agents (up to 1 M NaOH) have been used. feature, combined with the option of using external vent valves, results in maximum reliability during filter integrity testing.

The Sartocheck 4 plus has been designed according to the valid GAMP guidelines and complies with 21 CFR Part 11 Requirements. This unit offers a wide choice of electronic data transfer options, such as PDF files, network connectivity, Profibus, SD cards, and can be completely interfaced with the appropriate process control systems for automatic control of integrity testing.


Sartocheck 4 plus

The Sartocheck® 4 plus is the result of Sartorius 30 years experience in developing automatic filter integrity testers. Valuable productivity enhancing features and robust build quality have been combined with incredible ease of use to make the Sartocheck® 4 plus the only logical choice for integrity testing.

The Sartocheck® 4 plus provides the following unique combination of benefits:

Barcode Scanner for easy and reliable data entry (optional)
Intelligent selection of test program after scanning the filter
External pressure sensor and external valves (optional)
Automated cleaning function eliminates expensive service calls
Sophisticated Cleaning Kit available (optional)
Automatic detection of improper test setup (e.g. disconnected filters)
Multitasking menu
SD card reader for easy test program proliferation to other Sartocheck testers
Profibus communication (interface as accessory)

Integrity Test Methods
Bubble Point Test (BPT)
Diffusion Test (Diff)
Combined Test (Diff + BPT)
Pressure Drop Test
Water Intrusion Test (WIT)
Water Flow Test (WFT)
Multipoint Diffusion Test
Customer Specific Test
Automatic Test Time function for intelligent optimization of test times
 
Barcode Scanning
Using the optional barcode scanner allows easy and error-free entry of filter data into the unit. Sartocheck® 4 plus automatically locates the suitable test program that matches the scanned cartridge.
  
Cleaning Function
The patented cleaning function of Sartocheck® 4 plus allows the user to perform reliable cleaning of the complete internal pneumatics even with aggressive cleaning agents (up to 1 M NaOH). This unique feature provides security of the integrity testing procedure while eliminating the need for costly down time and service calls.
  
Network Concept
The netowrk solution for the Sartocheck® 4 plus incorporates the TCP-IP and FTP protocol standards, with data being transmitted via the Ethernet standard. Via standard RJ45 connection, all data can be easily up-loaded on a FTP server. Profibus communication can be used to allow bidirectional communication with process control system as a basis for complete automation.
  
Multiunit Concept
In order to increase productivity through parallel filter testing, up to four additional MultiUnits can be easily connected to the Sartocheck® 4 plus. This provides the equivalent testing capacity of five Sartochecks operating concurrently at a significant cost savings to the end user.
  
Qualification
Sartocheck® 4 plus ensures that all integrity tests are carried out with highest precision and accuracy. Our comprehensive Sartocheck® 4 plus validation documentation and world-class Service Team provide exemplary support for the user
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