Fully automatic filter integrity testing device without user interface. Up to 4 units may be connected to one main unit for 5 tests in parallel. 21 CFR p 11 and GAMP5 compliant. A large accessory package gives solutions for almost all customer needs.
The Sartocheck® 4 MultiUnit has been developed to enable parallel integrity testing of multiple filters in the biopharmaceutical industry. The MultiUnit is a identical copy of the Sartocheck® 4, without the user interface and the data management system. Each MultiUnit connected to a Sartocheck® 4 is operated and controlled by this Sartocheck® 4 via a RS485 connection.
Efficiency: Up to 4 MultiUnits can be connected to one Sartocheck® 4 allowing to integrity test up to 5 different filter systems in parallel including the testing capabilities of the Sartocheck® 4 itself. Testing up to 5 filters in parallel allows to reduce the time required for filter integrity esting in bio-pharmaceutical production significantly and increases the efficiency of your production process.
Flexibility: There is no relevant distance limitation between the Sartocheck® 4 and the connected MultiUnits. The MulitUnits can be placed all over your production facility and are centrally controlled and operated by the Sartocheck® 4. A printout of the test results of the MultiUnit is made by the printer of the Sartocheck® 4 and the test data can be transferred to a network for review and achiving.
Data transfer security: The Sartocheck® 4 MultiUnit is an independent test unit with its own power supply, electronics and pneumatics. It will maintain the test results even if switched off or if the connection is lost until the handshake communication with the Sartocheck® 4 confirms that the test results have been transferred successfully. If the MultiUnit is switched off during the test it will transfer a corresponding error message as soon as the communication has been automatically reestablished.
Traceability: The Sartocheck® 4 test result printout contains the serial number of the MultiUnit, the user name (log on identity), a unique file name and all the information that has been entered in the batch protocol. The included software, Sartocontrol, can be used to print the test results on an external printer in A4 format.
Patent pending thermal insulation: The Sartocheck® 4 and its MultiUnit feature a unique, patent pending separation of the electronic components and the temperature sensitive pneumatics in addition to the efficient vent fan. This superior solution avoids any thermal influence on the integrity test measurement from the unit itself.
Clean room venting adapter: The Sartocheck® 4 and its MultiUnit can be equipped with an optional venting fan adapter that allows to contain the out coming air in order to avoid any dispersion of particles in a clean room.
Sartorius Stedim Biotech Validation Package: The MultiUnit is delivered with a comprehensive validation package including an IQ & OQ protocol that can be accomplished by qualified Sartorius Stedim Biotech personnel. Assistance for PQ can also be provided from the Sartorius Stedim Biotech Technical Support Team.
|Measuring range||100 - 8.000 mbar|
|Primary Product Type||Systems|
|System Type||Integrity Testing Systems|
|Bubble point||100-8000 mbar acc. +/- 50 mbar|
|Data interface||PLC / Profibus - SCADA (adapter required)|
|Diffusion||Without ext. ref. tank: Cartridge systems up to net volume of 14 l; with ext. ref. tank: Cartridge systems up to 150 l|
|Dimensions (WxDxH)||460 x 390 x 150 mm|
|Relative humidity||10 %-80 %|
|Interface port||RS232, RS485, PLC port|
|Max. power input||74 W|
|Measuring Accuracy - Abs. deviation pressure measurement||max. ±9.5 mbar|
|Measuring Accuracy - Rel. deviation pressure measurement||0.1%|
|Measuring Ranges - Net volume||9 mL - 150L acc. +/- 4%|
|Measuring accuracy - diffusion||0.1-3000 ml/min acc. +/-5%|
|Net volume measurement||4 %|
|Operating Conditions - Temperature||+15 °C to +35 °C|
|Operating Pressure||min. 4 bar g or test p + 0,5 bar g (whichever highest); max 10 bar g|
|PLC port||binary signals 12 pins|
|Power requirements||100 - 240 V / 47 - 63 Hz|
|Pressure drop||All filter systems up to net volume of 150 L|
|Serial port MU||RS232 (Sartocheck® 4 plus only)|
|Serial port TU||RS232 | RS485|
|Water intrusion||0.1-999 ml/10 min acc. +/- 5%|