Filter Integrity Testing Service

Filter Integrity Testing Service is a critical validation process used in pharmaceutical, biotech, food, and healthcare industries to ensure the efficiency and reliability of sterilizing-grade filters. This service verifies that filters are free from defects, leaks, or structural damages that could compromise product sterility and quality. By conducting tests such as bubble point, diffusion, and pressure hold, filter integrity testing ensures compliance with GMP, FDA, and international standards. Regular integrity testing helps maintain process validation, product safety, and regulatory compliance, making it an essential quality assurance step in sterile manufacturing and filtration applications.

What is the Integrity Test for Filters?

Filter integrity tests evaluate whether a filter is intact and functioning as designed—free of leaks, ruptures, or defects. Common methods include:

Bubble Point Test: Determines the pressure required to force liquid through the largest pores.

Diffusion Test: Measures gas flow through a wetted filter to detect defects.

Pressure Hold Test: Assesses the filter’s ability to maintain pressure over time.

Water Intrusion Test: Used primarily for hydrophobic membrane filters.

These tests are conducted pre-use and post-use to ensure performance consistency and compliance with GMP and ISO standards.

Process Filter Integrity Testing For Critical Applications

Process filter integrity testing is a vital quality assurance step in industries such as pharmaceuticals, biotechnology, food & beverage, and healthcare, where sterile and contamination-free production is critical. This testing ensures that filters used in liquid and gas applications are functioning effectively, providing reliable microbial retention and particle removal. Key methods like the bubble point test, diffusion test, and pressure hold test are performed to verify filter performance without compromising the filter or the process.

By conducting regular integrity testing, manufacturers can confirm that filters meet regulatory standards, maintain product sterility, and prevent costly batch failures. It also helps in identifying potential risks early, ensuring consistent process safety and compliance with guidelines such as FDA, EMA, and GMP. For critical applications, process filter integrity testing is not just a regulatory requirement but a safeguard for product quality, patient safety, and overall operational reliability.

What Requires Filter Integrity Testing?

Integrity testing is mandatory for filters used in:

Sterile Filtration of Liquids & Gases

Final Product Filling in Pharmaceuticals

Biotech Applications Involving Cell Cultures

Medical & Laboratory Devices with High Contamination Sensitivity

Whether you’re using membrane filters, cartridge systems, or depth filters, integrity testing guarantees filtration reliability and sterility assurance.

Product-Specific Testing Capabilities

Validair Engineers offers tailored testing for:

Hydrophilic and Hydrophobic Filters

Liquid and Gas Filtration Systems

Single-use and Reusable Filter Assemblies

Process Filter Integrity Testing For Critical Applications

Process Filter Integrity Testing for Critical Applications is an essential quality assurance practice in industries such as pharmaceuticals, biotechnology, food, and healthcare, where sterility and product safety are non-negotiable. This service ensures that sterilizing-grade filters used in manufacturing and purification processes are intact, defect-free, and capable of providing reliable microbial retention. By performing advanced tests such as bubble point, diffusion, and pressure hold, integrity testing verifies filter performance without compromising product quality. For critical applications like sterile drug manufacturing, vaccine production, and biologics processing, filter integrity testing not only supports regulatory compliance with GMP and FDA guidelines but also minimizes contamination risks, reduces batch failures, and safeguards patient safety. It provides confidence that filtration systems consistently deliver reliable and validated results.

Bubble Point Test

Bubble Point Test is a widely used filter integrity testing method in pharmaceutical, biotech, food, and healthcare industries to verify the performance of sterilizing-grade membrane filters. The test measures the pressure required to force air or gas through a wetted filter membrane, displacing the liquid and forming the first continuous stream of bubbles. This pressure value, known as the bubble point, is directly related to the filter’s pore size and integrity. By confirming that filters meet specified parameters, the bubble point test ensures microbial retention, sterility assurance, and regulatory compliance. It is a non-destructive, reliable, and GMP-approved method for validating filter performance in critical applications.

Validair Engineers isn’t just a service provider—we’re a quality assurance partner. We help ensure your filtration systems perform flawlessly, every time.