Introduction
A filter integrity tester is an instrument used to test the integrity of the filters, such as the membrane filters, the HEPA filters, and the other filters used in the pharmaceutical, the biotechnology, the food, and the many other industries, and it verifies that the filter is intact and performs its filtration function correctly. The filter integrity test is performed by various methods, including the bubble point test, in which the pressure required to force the air through the largest pore of the wetted filter is measured, and the integrity is indicated by the comparison of the bubble point with the specification; the diffusion test, in which the rate of the diffusion of the gas through the wetted filter is measured; the pressure hold test; and the forward flow test, and the filter integrity tester consists of a pressure source, a pressure and a flow sensor, a filter holder, and a control and a display unit, and it performs the tests automatically, with features such as the automated test execution, the data logging, and the pass/fail determination; the filter integrity tester is used for the testing of the filters before and after the use, for the validation of the filtration processes, for the quality control, for the compliance with the regulations, and for many other applications, and it is an essential instrument for the assurance of the filter performance. Filter integrity testers are used in the pharmaceutical and the biotechnology industry, in the food and the beverage industry, in the water treatment, in the electronics industry, and for many other applications. With their integrity testing, filter integrity testers are essential for the verification of the filter performance.
Automated Filter Integrity Tester LIT-T2011
Automated Filter Integrity Tester with an input frequency of 50/60Hz, ensuring compatibility with standard power systems worldwide. It automatically manages stabilization and test times,...
Filter Integrity Tester LIT-T2010
Filter Integrity Tester operates at range of 100 to 10,000 mbar (150 psi), ensuring precise and reliable testing. Its advanced microprocessor-controlled system delivers fast, reliable, a...
Standards
ISO 7704:1985-Water quality-Evaluation of membrane filters used for microbiological analyses
Complies with the above standards, but is not limited to them.
Features
1. Filter integrity tester for verifying membrane and filter integrity.
2. Automated tester performing bubble point, diffusion and pressure hold tests.
3. For pharmaceutical, bioprocess and water filtration QC.
4. Includes tester, test head, printer, software and manual.
5. Confirms filter integrity non-destructively before or after use.
FAQ
Q1: What scenarios is this tester used for?
A: It verifies integrity of sterilizing grade membranes and cartridge filters using bubble point, forward flow diffusion and pressure hold tests, supporting sterile filtration QC in pharmaceutical and bioprocess operations.
Q2: What standards does it comply with?
A: It follows ASTM F838 for bacterial retention support, PDA Technical Report 26 for sterile filtration, related ISO and pharmacopeial guidance, and cGMP requirements, with pressure calibration traceable.
Q3: What is the warranty?
A: The tester carries a 12 to 24 month warranty covering the instrument and controls. Seals and filters are wear parts. Damage from fluid ingress or unauthorized repair is excluded.
Q4: Is it hard to operate?
A: Operation requires trained QC staff to select test type, wet the membrane and interpret values. We provide a manual, installation and training.
Q5: What is the lead time?
A: Standard models require 7-30 working days. In-stock units can ship within 3-7 working days. Custom configurations or large built-to-order systems may require additional time, and we confirm the exact schedule before order confirmation.
Q6: Is calibration required?
A: Calibrate pressure annually with traceable references and verify test algorithms. Keep IQ/OQ and calibration records for GMP use.
Q7: Are consumables universal?
A: Test seals and adapters are filter-specific, while calibration standards are certified references. Ongoing cost is minimal.
Q8: Can it be customized?
A: Options include test methods, housing adapters for cartridges or discs, automated sequences, 21 CFR Part 11 software and printers.
Q9: Is installation included?
A: Standard delivery includes the tester and manual. On-site installation, calibration and training are typically included or recommended.
Q10: What filters are compatible?
A: It handles wettable membrane and cartridge filters within the pressure range. It is not for dry un-wettable filters without compatible fluid, unsupported media, or filters beyond the test head capacity.
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