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Palltronic® Flowstar II Filter Integrity Test Instrument

Palltronic® Flowstar II Filter Integrity Test Instrument
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The Palltronic® Flowstar II integrity test instrument is a compact, splash-proof filter integrity test unit designed to be used in pharmaceutical production environments. The touch screen and the intuitive menu make the unit user-friendly, and data input very easy.

Benefits of Direct Flow Measurement

Incorporating direct flow measurement technology, test times can be reduced by 50% or more without compromising the very high accuracy of results. Real time sensing of flow stability and automatic control of test times ensures safe and accurate results for every test in the shortest possible time.

Test Capability

Forward Flow (Diffusive Flow) Test

The Forward Flow test performed by the Palltronic Flowstar II integrity test instrument has the following features:

  • It is performed at constant pressure
  • Flow is measured directly using a patented volume dosing technique
  • Flow is measured and recorded continuously
  • No need to measure upstream volume to calculate flow
  • Measurement range from 0.1 to 2000 mL/min

The benefits provided by these features compared to pressure decay devices are:

  • Very high measurement accuracy is achieved - within 1% of reference standard in validation studies
  • Volume determination and flow calculations are eliminated, reducing potential measurement errors
  • Real-time measurement enables shorter test times to be adopted
  • Flow measurement is more tolerant to changes in filter system temperature

Bubble Point Test

  • Initial low pressure (700 mbar, 10 psi) stabilization to ensure absence of major leaks in the filter test system
  • Progressive pressurization to bubble point (bulk air flow)
  • Result expressed to a resolution of 50 mbar (0.7 psi)
  • Continuous display of pressure and time

Benefits include:

  • Short test time
  • Accurate and reproducible results
  • Suitable for membrane discs, filter capsules and cartridges

Combined Forward Flow and Bubble Point Test

  • Forward Flow test followed automatically by a Bubble Point test
  • Results of both tests displayed graphically and on test printout

Water Intrusion Test

  • Test protocol similar to that for Forward Flow test
  • Results expressed as trans-membrane water flow
  • Resolution of 0.01 mL/min
  • Constant pressure direct flow measurement is ideal for Water Intrusion testing due to the special nature of the test, including:
  • Variable upstream volume between tests and during tests
  • Very low flow rates
  • Effects of temperature

Comprehensive Documentation of Test Results

Up to 100 test results can be stored in the memory of the Palltronic Flowstar II integrity test instrument. Test results can also be transferred to a computer via the integral RS232 port for comprehensive documentation control and traceability. Test results including line graphs are automatically printed on the internal thermal printer which is silent, fast and designed to make the printer suitable for cleanroom environments.

Validation

The Palltronic Flowstar software has been developed in accordance with Good Automated Manufacturing Practice (GAMP) guidelines. A detailed validation guide is available together with Installation Qualification (IQ) and Operational Qualification (OQ) protocols. A calibration and test certificate is supplied with every instrument and an extensive documentation package can be supplied on request for quality records. In addition, the Palltronic Flowstar II inegrity test instrument performs an automatic self-test on start-up, during which it checks all component functions including software algorithms.

Calibration and Servicing

Assurance of instrument calibration and continuous, trouble-free operation were major considerations in the development of the Palltronic Flowstar II inetegrity test instrument. The unique external vent valve prevents test liquids from entering the Palltronic Flowstar II integrity test instrument during venting of the instrument and an internal filter ensures contaminant-free air.

We are able to recommend a three year service interval minimising machine downtime. Units can be calibrated and serviced on or off-site by an experienced Pall technician. Pall recommends calibration at least once a year. Special care was taken to assure that the instrument can be calibrated following the requirements of the definition for calibration in the GAMP guidelines. The two internal pressure sensors and the Direct Flow measurement function are calibrated and certified.