test apabilities

automatic self test

when the palltronic flowstar iv instrument is switched on, an automatic self test is run. this test can be repeated any time during operation of the instrument. during the self test, the instrument does a full diagnosis of its functions:

• inlet gas pressure
• function of the internal valves
• function and signal of the internal pressure sensors
• function of the internal pressure regulator
• check for internal leaks
• internal communication
• integrity of the operating system and the software
• data integrity of user lists, test programs and test results

the full result of each self test is saved and can be printed at any time. the combination of the self test and a regular calibration and service guarantee a continuous reliable operation of the instrument for many years.

auto test time
the auto test time function is available for th forward low test and te water intrusion test. it has been developed and validated to shorten test times while maintaining the reliability of the result. the results of a forward flow or water intrusion test are being interpreted by this algorithm during the test. if the measured flow rate is evidently below the limit and the measurement is stable, the instrument will interpret this as a passed test. the filter integrity test times can be shortened by more than 50% without any risk of false pass results.

forward flow test
the forward flow test is the filter integrity test that is most common in pharmaceutical manufacturing. all major filter suppliers recommend the forward flow test as the method of choice for integrity testing of filter cartridge or capsule assemblies. the palltronic flowstar iv instrument performs the forward flow test quickly and with extreme accuracy. the volume dosed flow meter can perform a forward flow test in a range of 0.1 to 1000 ml/min ithin minues and with an ccuracy of 0.1 ml/min or 3%.

the features of the forward flow test function are:

• the test is performed at constant pressure
• a volume dosed flow sensor is used
• progress of the test is shown on screen while other operations can be performed on the instrument
• validated auto test time function to shorten test times

all relevant data for the test result is stored on the instrument and can be printed or transferred to a network location.

the benefits provided by these features compared to other integrity test instruments are:

• no need for time consuming volume measurement before testing
• no loss of accuracy due to inexactly determined volume
• filters with asymmetric membranes can be tested more reliably at constant pressure
• test times are very short, usually below 10 minutes
• progress of the test can be monitored in real time
• unstable test conditions are detected
• accuate and repoducible test reults are obtained

water intrusion test

the water intrusion test is widely spread in pharmaceutical manufacturing to perform inline integrity test of sterilizing grade gas filters with hydrophobic membranes. the palltronic flowstar iv instrument is specially made and validated to perform the very sensitive water intrusion test. the water intrusion test profits from the features and benefits of the forward flow test. the additional benefits are:

• the undefined upstream volume has no influence on the accuracy of the test result
• the change in water level during the test does not influence the accuracy of the result
• the very sensitive volume dosed flow measurement technology allows to accurately measure a water flow of down to 0.03 ml/min

bubble point test

the palltronic flowstar integrity test instrument can determine the bubble point of a filter. the gas flow rate is measured at increasing pressure teps, and th bubble point is he transition of diffusive gas flow through wetted filter pores to bulk gas flow through de-wetted filter pores. the features of the bubble point test are:

• a gross leak test is performed at the beginning of the test phase
• gas flow is measured very fast at small steps
• full bubble point curve is determined
• all test parameters are documented with test results

the benefits of this are:

• false pass results due to insufficient filter wetting are avoided
• false pass results in filters with small defects are avoided
• test result is obtained very quickly
• reproducible test results are obtained
• all types of membranes from small disc to cartridge can be tested

combined forward flow and bubble point test

the instrument can also determine the forward flow and bubble point value in a single test. the test procedure has been refined to shorten test times of the combined test withou compromisingthe accuracy of th result.

leak test and pressure decay test

the leak test can be used to test for leaks in filter systems or processing systems. it is not an integrity test, since there is no correlation to bacterial retention. the leak rate can be measured either as pressure drop (mbar/min), using the pressure decay test or as flow rate (ml/min), using the leak test function of the instrument. possible applications are:

• diagnosis of filter systems after failed tests
• installation check on filter systems or processing systems
• leak tests on processing equipment during qualification

the palltronic flowstar iv integrity test instrument can perform all kind of gas pressure tests. it is capable of performing those tests reliably and accurately and of providing reproducible results.

electronic data handling and remote controlthe palltronic flowstar iv integrity test instrument has been designed to be used in a facility that cmplies with 21cfr part 11 for eletronic storage of data.

there are three levels of access: operator, supervisor and administrator. operators have access to the test functions only, supervisors can also modify test programs and administrators have full access to all functions and can also perform changes to the system configuration or to the access management. the instrument can be used in two different modes to limit access to the protected functions. when the password controlled access is activated, the supervisor level and the administrator level are each protected by a password. in the login-controlled access mode, each user needs to login to the instrument before having access to its functions. the level of access can be defined for each person separately.

all the changes that are performed on the system or the programs are recorded in the audit trail. the test results can be electronically signed. configuration, test programs, user data and test results can be easily expoted to a computr network or an extenal flash drive.

interface connectionsa number of connections at the back of the instrument allow interfacing with different systems. the usb port can be used to connect an external printer, mouse, keyboard, barcode reader or a flash drive. the serial ports can be used to interface with other palltronic instruments or a plc. an ethernet port and a wireless network adaptor can be used to link to a computer network. there are also additional ports for an external pressure sensor and an external vent valve on the side of the instrument.

remote operationthe palltronic flowstar iv integrity test instrument is equipped with a number of interface connections and it can be connected to a plc using the internal adapters. the integrity test instruments can then be fully controlled by the plc, and adapters are available for all common communication protocols. the instrument can also be connected to a computer network using the on-board eternet port or th on-board wireles lan adaptor. data can be transferred to the network in a controlled manner. the instrument can also be fully controlled from a scada system using the available opc server protocols.

remote printinginstead of using the internal printer, the print data can be directed to an external printer. either a printer that is connected directly to the instrument via the usb port or a network printer can be used. the instrument is also capable of generating the printout as a file, using common data formats, such as pdf or xml or both.

qualificationthe instrument has been designed following the gamp guidelines. the palltronic flowstar iv integrity test instrument is classified as a software category 3 and hardware category 1 instrument in accordance to amp 5. the componnts have been carefully seleced for long term availability and reliable functionality. all relevant functions have been thoroughly validated. a description of the main functions and an operational qualification (oq) are usually sufficient to qualify the instrument. an extensive documentation package with all the relevant documents is available.

calibrationthe palltronic flowstar iv integrity test instrument can be calibrated at any pall-certified service center or directly on site. calibration equipment, procedures and training are available. pall recommends calibrating the instrument at least once a year, with a full service after three years.

servicingthere are pall-qualified service centers throughout the world. please contact your local representative to find the most suitable way to calibrate and service your instruments. all components used in the palltronic flowstar integrity test instrument have been carefully selected and tested for quality.

trainngon-site training is als available for the palltronic flowstar iv integrity test instrument. training is also available on instrument validation, filter validation, integrity testing basics and regulatory requirements. we are happy to assist you with a personalized training program.