Filter leak tester

pressurenon-destructivebenchtop

Overview
Filter Test Module is an add-on for the Modular-Lab eazy designed to assess the pressure-holding integrity of sterile filters used in radiopharmacy workflows.

Product Summary
Developed to support quality control in nuclear medicine, the module performs non-destructive pressure-hold tests after each synthesis and records results for traceability. It enables integrated monitoring without removing the filter from the cassette and is intended to complement existing QC procedures; it does not replace the post-aseptic-filling integrity test required for ready-to-use drug products.

Key Features

• Integrity testing of pre-wetted, non-vented sterile filters
• Documentation of test results included in the batch protocol
• Pass/fail reporting shown in the HMI scheme
• Concurrent operation with other QC procedures; no cassette removal required

Introduction
The integrity testing and documented evidence of sterile filters are required by multiple guidelines when handling radiopharmaceuticals. The Filter Test Module integrates with Modular-Lab eazy to standardize verification of filter integrity after synthesis.

Method
The module uses a non-destructive pressure-holding method suitable for pre-wetted, non-vented sterile filters. Multiple pressure-hold parameters are evaluated to determine whether the filter membrane remains intact. Results may vary slightly with filter type and wetting but do not indicate compromised integrity when within expected ranges. The method is a recognized alternative to bubble point and diffuse gas flow tests.

Result processing and operation
Test outcomes (pass/fail) are displayed in the HMI and logged in the batch protocol for traceability. In case of failure, the system provides user guidance including checking for loose connections and repeating the test. The test can be executed automatically after each synthesis and in parallel with other QC steps.

Technical specifications

• Non-destructive pressure-hold integrity test
• Designed for pre-wetted, non-vented sterile filters
• Performed after each synthesis; can run concurrently with other QC procedures
• No removal of filter from cassette required
• Pass/fail result displayed in HMI and recorded in batch protocol
• Recognized alternative to bubble point and diffuse gas flow tests
• Evaluation depends on filter type, filter preparation and membrane wetting
• Add-on compatible with Modular-Lab eazy synthesizers