Our consultants have many years of experience in this field, including:

On-site integrity testing

Off-site integrity testing

Documenting and performing IQOQ

methodologies and procedures on-site

Portable Filter Integrity Testers

Filter Test Trolleys

Filter Driers

Heatable Filter Housings

Accessories for Filter Integrity Tests

Filter Test Service and Upgrade

Validation Service (IQ,OQ,PQ)

Explosive environments (ATEX-Zone 1-T4)

Every single clients audit is more worth using a filter integrity test specialist, which is not the fabricator of the filter you use. We perform tests on all hydrophobic and hydrophilic filter cartridge from every brand.

Filter compatibility assessment is the first phase of a validation study. This test evaluates the integrity of the filter media and seals after exposure to the product under the worst-case process conditions. The membrane filters are tested for bubble point, tensile strengthand porometry before and after exposure to the product.

The Diffusion Test (Forward Flow Test)The Diffusion and Bubble Point TestThe Diffusion Tests with automatic filter wettingThe Pressure Drop TestThe Low Pressure Drop Test on sterile bagsThe Water Intrusion Test (WIT)The Water Intrusion Test on huge housings (150L)The Water Intrusion Tests with automatic filter dryingThe Water Intrusion Test with automatic housing cooling

We provide filter integrity tests for every sterile graded filter of e.g:Pall, Sartorius, Merck Millipore, Donaldson, Porvair and Amazon.Our consultants have many years of experience in this field, including;The ISPE´s Good Automated Manufacturing Process (GAMP) guidelines (currently at GAMP 5 for Compliant GxP Computerised Systems), together with the 21CFR11 regulatory requirements for Electronic Records and Electronic Signatures brought further requirements in development methodology and performance validation for this equipment.