Filter Integrity Tester

Fast detection speed, high cost performance

Introduction

Features

Specifications

Compliance

Applications

Inquiry

A filter integrity tester is a testing device that verifies the integrity of filter elements such as filter cartridges and filter membranes using a non-destructive method.

Widely used in industries such as pharmaceuticals, bioengineering, and food and beverage.

Versatile Testing Modes

High Testing Efficiency

Data Compliance

Features

Versatile Testing Modes: Supports Bubble Point, Forward Flow, Water Intrusion, Combined Forward Flow & Bubble Point, and Pressure Hold, meeting diverse filter integrity verification needs.
High Testing Efficiency： Powered by high-precision sensing technology and intelligent prediction algorithms, it delivers fast and reliable results while significantly reducing test duration.
User-Friendly: 10-inch color touchscreen with Windows OS, one-click testing, and multitasking capability.
Flexible Options: Optional needle or thermal printer, supports multiple communication protocols such as OPC-UA and Modbus TCP, adaptable for both online and offline use.
Data Compliance: 4-level user access control with GMP-compliant audit trail, supports dual-level approval,e-signatures, and data encryption.
Reliable Design: IP54 for dust and splash resistance, modular hardware architecture and redundant safety mechanisms.

Specifications

Weight	12kg
Input Voltage	(100-240)VAC
Input Frequency	50/60Hz
Input Power	125W
Fuse Blown	<5A
Dimensions	420mm×330mm×265mm
Dperating Temperature	(5～50)℃
Storage Temperature	(-10～60)℃
Ambient Humidity	≤85%RH,non-condensing
Test Range	(1)Forward Flow:(0.01～1000)mL/min (2)Water Intrusion:(0.01～100)mL/min (3)Bubble Point:(400～8000)mbar (4)Pressure Hold:(100～8000)mbar
Sensitivity	(1)Forward Flow:0.01mL/min (2)Water Intrusion:0.01mL/min (3)Bubble Point:50mbar (4)Pressure Hold:1mbar

Compliance

EU GMP Annex 1 for the manufacture of sterile medicinal products, February 2008

GMP: The integrity of the sterilised filter should be verified before use and should be confmed immediately after use by an appropriate method such as a bubble point, diffusive flow or pressure hold test.

US FDA Guideline on Sterile Drug Products Produced by Aseptic Processing, 2004

US FDA: Integrity testing of the filter can be performed prior to process and should be routinely performed post-use.

PDA@ Technical Report 26-2008

Where the claimed purpose of the filter is to sterilize, pre and post filtration integrity tests should be performed. Steps should be taken to ensure that the downstream side of the system remains sterile when perfomming a post sterilization, pre-use integrity test.