A filter integrity tester is a testing device that verifies the integrity of filter elements such as filter cartridges and filter membranes using a non-destructive method.
Widely used in industries such as pharmaceuticals, bioengineering, and food and beverage.
| Weight | 12kg |
| Input Voltage | (100-240)VAC |
| Input Frequency | 50/60Hz |
| Input Power | 125W |
| Fuse Blown | <5A |
| Dimensions | 420mm×330mm×265mm |
| Dperating Temperature | (5～50)℃ |
| Storage Temperature | (-10～60)℃ |
| Ambient Humidity | ≤85%RH,non-condensing |
| Test Range | (1)Forward Flow:(0.01～1000)mL/min (2)Water Intrusion:(0.01～100)mL/min (3)Bubble Point:(400～8000)mbar (4)Pressure Hold:(100～8000)mbar |
| Sensitivity | (1)Forward Flow:0.01mL/min (2)Water Intrusion:0.01mL/min (3)Bubble Point:50mbar (4)Pressure Hold:1mbar |
EU GMP Annex 1 for the manufacture of sterile medicinal products, February 2008
GMP: The integrity of the sterilised filter should be verified before use and should be confmed immediately after use by an appropriate method such as a bubble point, diffusive flow or pressure hold test.
US FDA Guideline on Sterile Drug Products Produced by Aseptic Processing, 2004
US FDA: Integrity testing of the filter can be performed prior to process and should be routinely performed post-use.
PDA@ Technical Report 26-2008
Where the claimed purpose of the filter is to sterilize, pre and post filtration integrity tests should be performed. Steps should be taken to ensure that the downstream side of the system remains sterile when perfomming a post sterilization, pre-use integrity test.
The product can be used for:
1) Disposable filtration system PUPSIT
2) Radiopharmaceutical production
3) Pharmaceutical liquid preparation system
4) Intake pressure recovery system on freeze dryers
