Filter Integrity Tester ASTM F316
Filter Integrity Tester is suitable for integrity testing of various filter membranes, disc filters, capsules, cartridges, etc. This tester is a compact, easy-to-use, and fully automated integrity test instrument, which performs the bubble point, enhanced bubble point, forward flow, water intrusion, and pressure decay tests for hydrophobic filters.
Applications
This instrument is applicable to determine the integrity test of filters.
It is suitable for testing the integrity of filters for the pharmaceutical and biotechnology industries.
It is suitable for integrity testing of filters in industries such as food and beverage, electronics, membrane manufacturing, air filtration, etc.
Standards
The Filter Integrity Tester can be used for filter integrity verification according to relevant industry requirements and test methods, including:
(1) ASTM F316 — Standard Test Methods for Pore Size Characteristics of Membrane Filters by Bubble Point and Mean Flow Pore Test
(2) ASTM F838 — Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
(3) ISO 13408 — Aseptic Processing of Health Care Products
(4) USP <1207> — Package Integrity Evaluation — Sterile Products
(5) PDA Technical Report No. 26 — Sterilizing Filtration of Liquids
(6) GMP — Good Manufacturing Practice Requirements for Pharmaceutical Production
(7) FDA Guidance for Sterile Drug Products Produced by Aseptic Processing
Note: Applicable standards depend on filter type, industry requirements, and validation procedures.
Technical Specifications：
| Items | Specifications |
| Test Range | Bubble point: 50 ~ 8000 mbar |
| Forward flow: 1 ~ 1000 mL/min | |
| Pressure decay: 50 ~ 8000 mbar | |
| Water intrusion: 0.01 ~ 100 mL/min | |
| Test Accuracy | Net volume: ±4% |
| Bubble point: ±50 mbar | |
| Forward flow: ±4% | |
| Pressure decay: ±1.0 mbar | |
| Water intrusion: ±0.01 mL/min | |
| Unit | Mbar, kPa, MPa, Psi, kgf/cm2 |
| Test Pressure | 50 ~ 10000 mbar (150 Psi) |
| Instrument Dimension | 330mm(W) x 550mm(D) x 270mm(H) |
| Net Weight | 14 kg |
| Power Supply | AC 100-240V 50/60Hz |
| (can be changed to local requirement) |
Feature
Complete testing methods: capable of automatic bubble point, diffusion flow, pressure decay, and water intrusion flow rate testing to meet various testing needs.
Real-time display and analysis: real-time display of test data and curves, monitoring the entire testing process, helping analyze the performance of membranes, filters, and filtration systems.
Precise and time-saving testing algorithms: automatic airflow adjustment device, advanced microelectronic circuit, combined with precise algorithm software, ensuring high accuracy and reproducibility while reducing testing time by 20% to 30%.
Scientific and convenient data management: supports USB and SD card, allowing easy import and export of data between the tester and computer. The upper computer uses the matching eDATA 840 software for database management and A4 page printing with multi-level permissions management: adopting a four-level authorization security management mode to make database use and management more secure, organized, and compliant with GMP production requirements.
Permanently saved test results: needle-type wide-line Chinese printing can simultaneously print test results and test curves for permanent archiving.
Convenient data transmission: equipped with an Ethernet interface, can connect to the factory network system, and is compatible with data collection systems or intelligent management systems for real-time data transmission.
Comprehensive audit trail: complete audit trail functionality, capable of recording events such as power on/off and login, as well as actions like creating, modifying, deleting, backing up, and verifying. It complies with the ALCOA principles, which require data traceability, readability, synchronicity, originality, and accuracy.
FAQ
(1) What is the purpose of a Filter Integrity Tester?
A Filter Integrity Tester is used to verify whether a filter membrane or filtration assembly meets required integrity standards. It helps identify defects, incorrect installation, or performance changes through tests such as bubble point, forward flow, and pressure decay.
(2) What is the bubble point test used for in filter testing?
The bubble point test determines the minimum pressure required to remove liquid from the largest pore of a wetted membrane. This value is related to pore size characteristics and is commonly used to confirm membrane filter integrity.
(3) Which filters can be tested with this instrument?
The Filter Integrity Tester is suitable for membrane filters, disc filters, capsule filters, cartridge filters, and hydrophobic air filters. Different test methods can be selected according to filter material, pore structure, and application requirements.
(4) Why is water intrusion testing used for hydrophobic filters?
Water intrusion testing is mainly applied to hydrophobic filters used for gas or air filtration. It detects possible defects by measuring water penetration behavior under controlled pressure conditions without damaging the filter.
(5) How does the tester support pharmaceutical quality control?
The instrument provides automated testing, electronic data storage, audit trails, and user permission management. These functions help laboratories maintain traceable test records and support GMP-related filter validation procedures.
Contact QINSUN for professional technical support and customized solutions.
Leave Message Get Price
