Filter Integrity and Bag Testing
Ensure Compliance With the QRM Expectations of EU Annex 1
The EU GMP Annex 1 sets high expectations in terms of quality risk management (QRM) and the contamination control strategy (CCS), requiring a proactive means of identifying, scientifically evaluating, and controlling potential risks to product quality. For filter integrity testing and bag testing, this means eliminating the risk of false passes or false failures and ensuring the process is free from cross-contamination.
The resistance of all Sartocheck® 5 versions to VHP fumigation, combined with an internal pneumatic cleaning function, supports contamination control and helps fulfill Annex 1 CCS requirements.
The Sartocheck® 5 Plus Filter Tester and Sartocheck® 5 Plus Universal offer automatic detection of operator errors that could otherwise go undetected and generate false results, further supporting the Annex 1 requirement for QRM.
Filter and Bag Testing Portfolio
The Sartocheck® 5 Filter Tester performs all standard integrity tests while delivering exceptional data integrity, intuitive usability, and advanced occupational health and safety compliance.
The Sartocheck® 5 Plus Filter Tester builds on these capabilities, adding automation and elevating QRM through the automatic detection of abnormal test conditions that could otherwise go unnoticed and produce false results.
The Sartocheck® 5 Plus Universal offers the same features and performance as the Sartocheck® 5 Plus Filter Tester but adds Point of Use Leak Testing of up to 2,000L bags if combined with the Accessory Kit for Bag Testing and even bag integrity testing of 2D bags if combined with the FlexAct BT.
| Sartocheck® 5 | Filter Tester | Plus Filter Tester | Plus Universal |
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| Filter Testing & Data Integrity |
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| Bag Testing (requires Accessory Kit in option) |
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| Automation (OPC UA, PAS-X* and Modbus TCP) |
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| QRM-related program parameters |
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| OSH - ATEX | IECEx | FM** |
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| External Venting or Cleaning Kit |
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| Software maintenance |
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| Roadmap of additional features*** |
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| View Product | View Product | View Product |
*PAS-X requires software version 3.2.0
**Does not apply to the Accessory Kit for Bag Testing
***Check with Field Application Specialist for additional information
Surpass Quality Risk Management Requirements
The regulatory focus on QRM (namely, ICHQ9 and the new Annex 1 developed by the EMA in cooperation with the US FDA, WHO, and PIC/S) also applies to filter integrity testing, point of use leak testing of bags and integrity testing of bags, as a fundamental element of sterility assurance. The Sartocheck® 5 uses program-specific parameters to support the automatic identification of testing anomalies in advance or during the test for both filter and bag testing. This avoids time-consuming and costly deviations, potential drug recalls, and 483 warning letters.
Reach the Ultimate Level of Data Integrity
Filter integrity test, point of use leak test and bag integrity test values are part of the batch record and serve as critical justification for drug release. Long-term data reliability is therefore essential to prevent quality deviations and avoid potential FDA 483 warning letters.
Data integrity and security in testing results should not be viewed solely as an IT concern: they represent a global business risk. Inadequate standards can not only disrupt pharmaceutical operations but, more importantly, compromise patient safety.
Experience the Comfort of Intuitive Usability
An optimal user experience speeds up process workflows due to intuitive guidance and ease of use. The high-quality touchscreen of the Sartocheck® 5 provides a unique viewing angle, an intuitive user interface, a logical menu structure, and simple data entry options. This allows straightforward programming of tests and QRM enhancement features, as well as error-free operation in GMP production environments.
ATEX certification
Filter integrity testing may involve inflammable alcohol in case of retesting. The Sartocheck® 5 is ATEX-certified for use in explosive environments and compatible with all common cleaning agents and VHP. This ensures maximum safety for both operators and facilities.
Sartocheck® 5 Plus WIT Trolley
Simplify Annex 1 Compliance
The Sartocheck® 5 Plus WIT Trolley has been developed to support compliance with increased regulatory expectations in EU GMP Annex 1, sections 8.88 and 8.89, for integrity testing of critical and non-critical vent filters. By enabling water intrusion testing (WIT), the trolley reduces testing effort and helps ensure reliable, reproducible results. It is designed for plug-and-play setup, requiring only connection to the top and bottom of the filter housing. Automated overfilling helps completely fill the housing and eliminate air bubbles, while an anti-backflow valve prevents test water from flooding the Sartocheck® 5 Plus during filling.
Contamination control strategy
After testing, the filter housing is actively drained with compressed air. The test water is directed to drain and is not reused, helping minimize the risk of contamination in the pressure vessel. All wetted stainless-steel parts of the WIT Trolley, including the pressure vessel and overflow tank, can be steamed in-line at up to 134 °C. A temperature sensor at the lowest point verifies that the temperature is maintained during the defined steaming time.
Supporting Products & Services
Learn More About Filter Integrity Testing
Software & Accessory Upgrade Overview
Automation and Performance Upgrade Q3 2026 - Version 3.2.1
Bag testing capacity (3.1.1 - Sartocheck® 5 Plus Universal)
PAS-X automation compatibility (3.2.0 - Sartocheck® 5 Plus FT & UN)
Stability improvements (3.2.1 - all Sartocheck® 5 variants)
Testing and Performance Upgrade Q3 2025 – Version 3.1.1
- Activated interface (GPU) acceleration
- Displaying calibration date of connected accessory kits
- Software rebranding
- Stability improvements
- New software version for bag testing (Sartocheck® 5 Plus Universal)
Testing & Performance Upgrade Q2 2024 – Version 2.3.2
- Bubble point pressure stabilization (no change in the testing algorithm)
- Improved data export performance
- Double backup of calibration data
- Improved keyboard Pinyin-function (Mandarin)
- Stability improvements
General Performance Upgrade Q1 2023 – Version 2.2.1
- Stability improvements
- Audit trail improvements
- Connectivity improvements
- Cleaning cycle improvements (CCS)
Accessory Hardware Upgrade Q3 2022
Contamination Control Strategy (CCS)
- Accessory Kit allowing cleaning of the internal pneumatics with up to 0.5M NaOH at 50 °C.
- Recommended standard cleaning at room temperature with 0.1M NaOH.
- Combined with the Accessory Kit for external venting, the Cleaning Kit is part of a comprehensive CCS of the Sartocheck® 5 thus fulfilling the most stringent expectations of Annex 1 compliance.
Software Upgrade Q2 2022 - Version 2.1.1
Data Integrity
- New root file system – Higher security
- Blocking of abusive test repeats (e.g., max 3 tests per filter)
- Mandatory Why Comment when modifying programs
HSE | OSH (Health Safety & Environment | Occupational Safety and Health)
- Fully automated cleaning function (software)
- Accessory kit for automated cleaning – Not included in the upgrade
Usability
- Flexible entry of diffusion values for TFF cassettes (max 4,800 mL/min)
- Scheduled exports of Audit Trail PDFs
- Improved overall stability
Automatic Early Detection of Operator Errors
Human error can never be completely eliminated. A key strategy for reducing risk priority number (RPN) in FMEA is to improve detectability. A false pass during an integrity test becomes a serious deviation only if the operator discards the filter before the error is detected.
The Sartocheck® 5 Plus Universal uses program-specific QRM parameters to enable fast, automatic detection of operator errors, allowing immediate corrective actions before costly deviations occur.
- Over 5,000 units installed in the bioPharma industry since launching in 2019
- Software life cycle management, including risk assessments for upgrades
- QRM Handbook available, with FMEA suggestions included
Frequently Asked Questions
For hydrophilic filters, there are two frequently used integrity tests:
- The diffusion test, also called forward flow, consists of measuring the gas flow through the wet membrane at a defined differential pressure.
- The bubble point consists of detecting the differential pressure at which a disproportionate increase in gas flow occurs as the wetting liquid is expelled from the largest pores of the membrane.
A combined diffusion and bubble point test can also be performed, but it is not a regulatory requirement to conduct both.
For hydrophobic filters, there are three frequently used integrity tests:
- The water intrusion test (WIT) consists of measuring the amount of water that evaporates from the upstream to the downstream side of the membrane at a defined test pressure. If the size of the filter allows for WIT, this is the preferred method.
- The diffusion test is performed after wetting the hydrophobic membrane with, for example, 60% IPA, 70% IPA, or another suitable low surface tension liquid. It is a good alternative if the WIT fails twice.
- The bubble point test is also performed after wetting the hydrophobic membrane with a suitable low surface tension liquid (e.g., 60% or 70% IPA). Like the diffusion test, it is a good alternative if the WIT fails twice.
The bubble point is the differential pressure at which the wetting liquid is expelled from the largest pores. It is correlated with the size of the largest pores in the membrane. From a general perspective, the diffusion test is considered more sensitive, even though it is not correlated with pore size. It should be recognized that each method has strengths and limitations that must be evaluated based on the specific circumstances of the test.
Annex 1 of EudraLex Volume 4, released in August 2022, is currently the most frequently discussed GMP guideline in filter integrity testing. Other relevant guidance documents include:
- WHO Annex 2, TRS 1044 (October 2022)
- FDA Guidance for Industry (September 2004)
Pre-use post sterilization integrity testing (PUPSIT) refers to verifying the integrity of a sterilizing-grade filter after sterilization and before use, as required by EU Annex 1 and WHO Annex 2. Pre-use testing of sterilized filters was first introduced in EU Annex 1 in 1996 (Section 85), although the term PUPSIT was not used until the version released in 2022.
Integrity testing is a regulatory requirement and a fundamental element of sterility assurance, but by itself, it is of limited value. In fact, a sterilizing-grade filter can only be considered effective if the integrity test is passed, if assurance is given that the result is not a false pass, if the filter type has been validated with a bacterial challenge test under process conditions, and if the filter supplier has a solid quality management system in place to ensure reproducible filters.
