Filter integrity testers for pharmaceutical, biotechnology and critical membrane filtration applications. Compare compact portable and mobile trolley systems for Diffusion / Forward Flow, Bubble Point, Pressure Hold and Water Flow / Water Intrusion testing, with options for capsule filters, automatic wetting, single-use systems and qualification support.
Filter integrity testing is a non-destructive method used to verify whether a membrane filter or filtration system remains intact and performs within its defined integrity limits. Depending on the membrane and application, common methods include Diffusion / Forward Flow, Bubble Point, Pressure Hold and Water Flow / Water Intrusion testing.
Integrity testing is widely used around critical membrane filtration processes in pharmaceutical manufacturing, biotechnology, laboratory development and high-purity processing. The correct test method and acceptance limits depend on the specific membrane filter, its validated specification and the process in which it is installed.
Filtra's primary integrity-testing platforms are the it-02 compact portable tester and the ita-02 mobile trolley system. Both are mobile systems, but they are designed for different ways of working.
The it-02 is a compact instrument that can be carried directly to the filter or test location. The ita-02 is installed on a wheeled trolley and is designed as a complete mobile test station that can be rolled between production areas.
Compact, hand-portable filter integrity tester for flexible use in laboratories, cleanrooms and production environments.
Wheeled integrity-testing station for routine movement between pharmaceutical and biotechnology production locations.
| Selection factor | it-02 | ita-02 |
|---|---|---|
| Mobility | Hand-portable mobile tester | Wheeled mobile trolley system |
| Format | Compact standalone instrument | Complete mobile production test station |
| Approx. weight | 11.5 kg | 55 kg |
| Typical use | Flexible testing across laboratory, cleanroom and production locations | Routine testing across multiple pharmaceutical production stations |
| Movement | Carried directly to the test point | Rolled between process or production stations |
| Diffusion / Forward Flow | Yes | Yes |
| Bubble Point | Yes | Yes |
| Water Flow / WIT-type testing | Yes | Yes |
| Capsule filter testing | Direct connection available | Direct connection available |
| Automatic wetting | Optional | Optional |
| Qualification support | IQ / OQ with PQ support available | IQ / OQ with PQ support available |
No single integrity test is suitable for every membrane or filtration process. The test method must be matched to the membrane characteristics, wetting behaviour, filter format and validated acceptance limits.
A wetted membrane is pressurised below its bubble point and the gas flow passing through the liquid-filled membrane structure is measured.
Diffusion or Forward Flow testing is commonly applied to wetted hydrophilic membrane filters.
Bubble Point testing determines the pressure behaviour associated with displacement of the wetting liquid from the largest membrane pores.
The measured result must be evaluated against the validated specification for the particular membrane filter.
Water-based integrity testing is used for suitable hydrophobic membrane filters such as PTFE gas and vent filters.
New-generation integrity-testing systems may refer to this procedure as the Water Flow Test (WFT), historically also known as Water Intrusion Testing (WIT).
Pressure-based testing evaluates the pressure behaviour of a closed filter or test system during a defined test period.
The method and acceptance criteria must be established for the particular filter or system being tested.
Automatic upstream-volume measurement helps determine the connected system volume required for certain integrity-test calculations and test sequences.
Compatible systems can perform Diffusion and Bubble Point testing as part of a programmed test sequence, reducing manual handling between tests.
| Membrane / application | Typical integrity-test approach | Examples |
|---|---|---|
| Hydrophilic liquid membranes | Diffusion / Forward Flow, Bubble Point, combined testing or applicable pressure-based testing | PES, hydrophilic PVDF, Nylon |
| Hydrophobic gas & vent membranes | Water Flow / Water Intrusion-type testing or another validated method specified for the filter | Hydrophobic PTFE |
| Capsule membrane filters | Method selected according to membrane type, filter configuration and validated filter limits | PES, PTFE, PVDF, Nylon and other membrane capsules |
Capsule filters are widely used in laboratory, process-development, pilot-scale and single-use filtration systems. Their compact disposable format makes them useful where a complete membrane and housing assembly is replaced as one unit.
The it-02 and ita-02 platforms can directly accommodate compatible small membrane-filter formats using a dedicated filter holder. Depending on the configuration, this can include capsule filters, mini-cartridges and other small-format membrane filters.
This creates a direct workflow between filter selection, filtration trials, integrity testing and process scale-up.
Explore Filtra's capsule and laboratory membrane filters , including PES, PTFE, PVDF, Nylon and polypropylene configurations.
Modern pharmaceutical and biotechnology processes increasingly combine disposable tubing, bags, bottles and capsule filters into preconfigured single-use fluid paths.
Integrity testing can therefore form part of a broader single-use process strategy in which the membrane filter and the surrounding disposable assembly are considered separately but integrated into the same process.
The new-generation integrity-testing platforms can be configured for direct capsule filter testing, while optional hardware can extend selected systems to low-pressure testing of sterile bag assemblies.
This allows Filtra to support the complete process around single-use fluid handling, capsule filtration and integrity verification.
Correct and repeatable membrane preparation is important for integrity tests that depend on a wetted membrane.
The it-02 and ita-02 can be configured with automatic wetting equipment for compatible filters. Controlled wetting helps reduce operator-dependent variation and allows the integrity test to follow directly after the wetting sequence.
Configurations are available for both cartridge filters and capsule filters, including capsule applications within single-use systems.
For pharmaceutical and biotechnology applications, the integrity tester is not only a measuring instrument. Test-program management, traceable results, electronic records, qualification and calibration can also be important parts of the overall testing system.
The new-generation it-02 and ita-02 platforms include functionality for electronic test reporting and regulated production environments.
Integrity-testing equipment used in regulated processes may require a documented equipment lifecycle that includes installation, operational verification, periodic calibration and process-specific performance qualification.
Documents correct installation, system components and relevant equipment documentation.
Verifies equipment functions, operating modes and measurement performance using appropriate reference equipment.
Supports verification of the integrity tester in combination with the customer's actual filter systems and process requirements.
Periodic maintenance and calibration should be incorporated into the lifecycle of the integrity-testing equipment to help maintain measurement reliability.
In addition to the it-02 and ita-02 flagship platforms, specialist equipment is available for particular environments, methods and supporting test procedures.
Start with the filter and test method rather than the instrument itself. The best integrity-testing configuration depends on how and where the membrane filter is used.
| Requirement | Recommended direction |
|---|---|
| Compact tester carried between test points | it-02 compact portable integrity tester |
| Complete workstation rolled between production areas | ita-02 mobile trolley integrity-testing system |
| Hydrophilic liquid membrane | Evaluate Diffusion / Forward Flow, Bubble Point and applicable pressure-based test methods according to validated filter limits. |
| Hydrophobic gas or vent membrane | Evaluate Water Flow / Water Intrusion-type testing according to the membrane-filter specification. |
| Capsule filter | Select the appropriate test method for the membrane and use a compatible small-filter or capsule connection. |
| Automatic membrane preparation | Specify automatic wetting for a compatible capsule or cartridge-filter configuration. |
| Single-use bag assembly | Specify a compatible low-pressure system-testing configuration; additional hardware is required. |
| Hazardous environment | Evaluate the ATEX integrity-testing system for the specific installation zone and requirements. |
| Regulated pharmaceutical application | Define electronic reporting, calibration and IQ / OQ / PQ requirements during system specification. |
Membrane filtration is used throughout pharmaceutical and biotechnology processing for liquid filtration, gas filtration, venting and critical process protection.
Integrity testing provides a method for checking the installed membrane filter against defined acceptance criteria without destructively testing the filter. Depending on the process, testing may form part of pre-use, post-use, validation or routine quality-control procedures.
Filtra supports the broader filtration workflow with membrane filters, capsule filters, single-use fluid-path components and integrity-testing equipment.
For application-level guidance, visit Pharmaceutical & Biotech Filtration Solutions or Sterile Filtration of Injectable Drugs .
Provide the filter type, membrane material, filter format, integrity-test method, process environment and qualification requirements. Filtra can help select a portable, trolley-mounted or specialist integrity-testing configuration and the required connections and accessories.
Filter integrity testing is a non-destructive method used to verify whether a membrane filter or filtration system remains intact and meets its defined integrity-test limits. The correct test method and acceptance criteria depend on the membrane filter and validated process.
Depending on the tester and configuration, available methods can include Diffusion / Forward Flow, Bubble Point, combined Diffusion and Bubble Point, Pressure Hold or Pressure Drop, Water Flow / Water Intrusion testing and upstream-volume measurement.
Both systems are mobile. The it-02 is a compact hand-portable integrity tester that can be carried to the test point. The ita-02 is a complete wheeled trolley-based integrity-testing station designed to move between production locations.
Yes. Compatible capsule filters can be integrity tested using the appropriate method for the membrane and filter specification. The it-02 and ita-02 include options for direct connection of suitable capsule and other small-format membrane filters.
Hydrophilic PES membrane filters are commonly evaluated using tests such as Diffusion / Forward Flow and Bubble Point. The exact method, test pressure and acceptance limits must follow the specification for the individual filter and validated process.
Suitable hydrophobic PTFE filters can be tested using Water Flow or Water Intrusion-type integrity testing. The exact procedure and limits depend on the specific filter and its validated integrity specification.
Water Flow Test (WFT) is terminology used for water-based integrity testing of suitable hydrophobic membrane filters. The procedure has historically also been referred to as Water Intrusion Testing (WIT). Always follow the terminology and validated method specified for the individual filter and test system.
The membrane filter within a single-use system can be tested using the appropriate integrity-test method. Selected integrity-testing platforms can also be extended with optional hardware for applications such as low-pressure testing of sterile bag assemblies.
Yes. Compatible it-02 and ita-02 configurations can include automatic membrane wetting for cartridge filters or capsule filters. Controlled wetting can improve repeatability before tests that require a wetted membrane.
The new-generation it-02 and ita-02 platforms provide electronic test-reporting and data-management functionality, including storage of test results and electronic report handling for regulated environments.
Qualification support can include Installation Qualification (IQ), Operational Qualification (OQ) and support for Performance Qualification (PQ) of the integrity tester in combination with the installed filtration system.
Start with the membrane type, filter format and validated test method. Then consider whether the tester must be hand-portable or trolley-mounted, whether automatic wetting or single-use system testing is required, the installation environment and the required reporting, calibration and qualification documentation.
Knowledge Center
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