Validation Services

Feel confident your filters will perform as expected with our complete validation services package. Our experts ensure your filters meet regulatory standards and function reliably through our end to end validation services including:

Filter integrity and bacteria retention testing
Chemical compatibility analysis
Extractables & leachables studies
Throughput optimization
Documentation for regulatory submissions

Filter Integrity Test

Ensuring the integrity of your critical sterilizing filter is essential, so it should be tested both before and after use. Our team can assist you in identifying the minimum integrity test specification for 1) Filters wetted with your drug product or 2) Filters wetted and rinsed with a specific fluid.

Bacterial Retention Testing (BRT)

This is a critical step in filter validation for biopharmaceutical manufacturers as it helps ensure that filters will produce a sterile effluent even when loaded with bacteria. Testing is conducted using end-user worst-case processing conditions to determine the ability of a sterilizing-grade filter to retain a minimum challenge of 10⁷ bacteria per cm² of filter area.

Chemical Compatibility Test

Chemical Compatibility studies are performed to ensure that the filter undergoes no adverse effects on usage with the pharmaceutical product. These tests are performed on the filter prior to and after worst-case exposure. Compatibility is determined by comparing: Integrity test results using the reference fluid, Flow Rates, Membrane Thickness, Pore Morphology.

Throughput Study

During the prefiltration/filtration process, colloids or suspended particles start to accumulate on the filter membranes, leading to gradual pore plugging. It is important to understand the throughput capacity of the filter with respect to different filtrates.

Extractables & Leachables

The FDA defines the two terms as follows:
Extractables: Organic and inorganic chemical species that can be released from the surfaces of components used in the manufacture and storage of drug products under laboratory conditions (accelerated or exaggerated temperatures, solvents or surface exposure).

Leachables: Organic and inorganic chemical species that can be released from the surfaces of components used in the manufacture and storage of drug products under conditions of normal use.
Our E&L study is made up of two separate but interrelated projects. The first is the extractables study, which establishes a baseline for the subsequent leachables study. The latter involves a series of tests carried out at predetermined intervals on the pharmaceutical product throughout its shelf-life.