Filter Integrity Tester

Filter Integrity Tester

Product Introduction:

The VEC-BP Series Fully Automatic Filter Integrity Tester is an independently developed filter validation instrument supporting four core test modes: bubble point, pressure hold, diffusion flow and water ingress. Compliant with GMP and 21 CFR Part 11, it rapidly verifies the integrity and sealing performance of filter membranes, filter cartridges, capsule filters and membrane packs, fulfilling filter validation, audit and data traceability demands for pharmaceutical and biotech applications.

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Description

The VEC-BP Series Fully Automatic Filter Integrity Tester, also known as a filter cartridge integrity tester, is dedicated equipment for filter validation. Equipped with high-precision digital pressure sensors, it delivers superior test accuracy and outstanding reproducibility. The tester identifies filter medium precision, detects membrane damage and checks seal integrity of filter assemblies to guarantee stable and reliable operation of filtration systems.

This unit integrates four industry-standard integrity test methods: bubble point test, pressure hold test, diffusion flow test and water ingress test. It is built with multi-level user access control, audit trail and electronic signature functions, with an optional database management system. Its matching professional software aligns with 21 CFR Part 11, supports FDA audit review and satisfies electronic record compliance requirements for the pharmaceutical sector.

The system runs fully automatic tests without continuous manual operation. It comes with a 10.4-inch touchscreen with an intuitive Chinese HMI for straightforward operation. Featuring a portable and compact lightweight structure, the tester supports on-demand printing of test parameters, results and curves. With 16 GB internal storage, it can archive up to 1 million historical test records to satisfy GMP data traceability rules. Standard configurations can be customized to fit diverse field testing scenarios.

Application

Compatible Filter Types

· Disc membrane filters: Φ25 mm–Φ300 mm

· Standard pleated filter cartridges: 2.5″–40″, single-cartridge and multi-cartridge housings up to 9 cartridges

· Tangential flow membrane packs

· Mini filter cartridges and capsule filters

· 2.5″–40″ air vent filters

· Custom special-size filter cartridges

Application Industries

1. Pharmaceuticals & Biotechnology: Sterilizing filter validation for sterile formulations; pre-use and post-use integrity testing for GMP and pharmacopoeia audits

2. Medical Devices: On-site and factory integrity confirmation for liquid filtration systems and vent filters

3. Food & Beverage: Quality validation for liquid and gas sterile filtration processes

4. Filter Manufacturers: Factory outgoing integrity inspection for filter membranes, cartridges and capsule filters

5. R&D Laboratories: Membrane filtration process development and filter media performance characterization

TECHNICAL PARAMETERS

Key Parameters	Range
Operating pressure	100-10000mbar
Test range	Basic bubble point: 100–8,000 mbar; diffusion flow: 1–600 ml/min; water ingress: 0.01–100 ml
Test functions	Soak testing, pressure-holding testing, diffusion flow testing, water ingress testing
Scope of application	Symmetrical and asymmetrical membranes, needle-type filters, chamber filters, plate filters, cartridge filters, ultrafiltration cassettes, etc.
Test accuracy	Net volume test: ± 4 per cent; bubble point: ± 50 mbar; diffusion flow: ± 4 per cent; water ingress: ± 0.05 ml/min
Audit trail	Multiple event logs; exportable but not editable; ≤3 years
Access control	Four-level access control, compliant with FDA 21 CFR Part 11 requirements
History log	16G memory storage, ≥3 years
Record backup	Supports data export to USB sticks
Display screen	10-inch colour touchscreen
Power supply	100-240 VAC, 50/60Hz, 120W
Dimension	400×270×260mm

FAQS

1.What test methods does the VEC-BP Series filter integrity tester support?

The VEC-BP Series supports four standard integrity tests: bubble point test, diffusion flow test, pressure hold test, and water ingress test. These methods meet GMP and pharmacopoeia requirements for sterile filter validation.
2.What types of filters can this integrity tester test?

It is compatible with disc membrane filters, pleated filter cartridges, capsule filters, mini cartridges, air vent filters, and tangential flow membrane packs. Custom special-size filters are also supported.
3.Can the VEC-BP tester store test data and print reports?

Yes. The built-in 16 GB storage saves up to 1 million test records. It supports real-time printing of test parameters, results, and curves for GMP traceability.
4.How long does a typical integrity test take?

Test duration varies by method. Bubble point test takes roughly 2 minutes, diffusion flow and water ingress tests take about 7 minutes, and pressure hold test can be finished within 3 minutes.
5.What is the typical lead time for the VEC-BP series filter integrity tester?

Standard units normally have a lead time of 2–4 weeks after receipt of deposit. Customized configurations will require extended lead time, which will be confirmed in the formal quotation.

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Filter Integrity Tester