In order to sustain a sterile filtration it is necessary to check the integrity of filter elements at regular intervals. For this purpose Donaldson offers test equipment which are used to test depth filters as well as membrane filters.
Filter Test Center (FTC) The FTC is used to test the integrity of sterile depth filter via DOP test procedure. Ease of operation and a menu driven user interface are the features of the FTC. All operating sequences are shown in a LCD display. This means, the user is always informed on what is currently going on and which steps have to be taken next. The device automatically realises (either after a set period of time or after a restart) a zero point comparison and a measurement of test aerosol concentration. This ensures reliable and reproducible results at any time. These results are evaluated (good/bad) and logged by a printer or they can be directly processed via a serial interface to a PC. Compressed air inlet: Min. 5 bar Max. 10 bar Maximum air consumption: 35l/min Test aerosol concentration: 930 mg/m³ Electric voltage: 220/240 V AC 50 Hz 110/120 V AC 60 Hz Weight: ca. 32 kg Dimensions: 470x555x330 (LxWxH) Operating temperature: 15°-40 °C Humidity of air: max. 85 % r.H.
Dispersed Oil Particle Test (DOP) The DOP test is only used to test the integrity of sterile depth filters and shows the retention rate of the filter elements. The testing procedure is similar as described by EN 1822 and by ASTM (American Society for Testing and Materials) D 2986-91. An aerosol generator is used to produce a paraffin oil aerosol with a particle spectrum of 0.1 to 0.5 μm. The test aerosol is used to load the filter element. A laser particle counter counts the number of particles that pass the filter element. A “sterile” element must have a LOG reduction value (LRV) of more than 7 per cm2 filtration area. That means that out of 107 particles only 10° (= 1) particle is allowed to pass per cm2 of the filtration area. Then the LRV is higher than 7 and the element is considered as “sterile”.
Membra-Check The Donaldson Membra-Check is a handy filter integrity test unit for both hydrophilic and hydrophobic membrane filters. Beside all integrity tests this unit can be used as a calibration pressure gauge (0 – 6 bar) and is capable to check unknown volumes (e.g. the upstream volume of a filter housing; 0.1 l – 32 l). Besides the integrated software a GMP/GLP compliant version is available. A printer is included for on-site testing without a PC connection or as stand alone.