MedIntegrity MFT-600 Manufacturer & Supplier

Notes From Our Technical Documentation

Model Information & Core Product Description

Model: MFT-600 The MedIntegrity MFT-600 Packaging Leak Tester is the most sophisticated and full-featured non-destructive micro leak tester on the market today for liquid filled and lyophilized vials, ampoules, empty & prefilled syringes, as well as other types of rigid and flexible packaging.Test components are optimized for high sensitivity applications and high resolution requirements of the pharmaceutical industry. The Medintegrity MFT-600 Packaging Leak Tester technology utilizes the ASTM vacuum decay leak test method (F2338-09) recognized by the FDA as a consensus standard for package integrity testing. The modular,portable design of the MFT-600 is suitable for a wide range of testing applications in both laboratory and production environments. The operator touch screen display shows test result data and provides easy to use screens for all machine operations.

Technical Guide

How vacuum decay finds a leak

ASTM F2338, the vacuum decay method, is a physical measurement of package integrity — no dye, no destruction, no interpretation. The package is sealed into a test volume, the volume is brought to a set vacuum level, and the instrument watches the pressure. An intact package holds the volume constant. A leaking one loses gas volume over time, and the ideal gas law turns that time-based pressure change into a quantified rate of change of the gas volume lost to leakage.

The standard is not a suggestion: it is the FDA-recognized consensus standard for package integrity testing, and the MedIntegrity technology was used in developing F2338 itself. What you get out is a number — the leak rate — that you can compare against an acceptance limit and trend across a production run.

What 'non-destructive and quantitative' changes in QC

Dye ingress and destructive sampling answer a question about the sample you destroy. The MFT-600 answers it about the package you are actually shipping: liquid filled and lyophilized vials, ampoules, empty and prefilled syringes, and other rigid and flexible formats, with the capability to detect leak rates as low as 2 microns depending on the package specification.

That distinction matters at release. The tested unit can go on the line; the result stays in the record. A non-destructive quantitative method means the same instrument can serve method development, in-process checks and release testing — one documented method set instead of three.

Modular, portable, and placed where the work is

The design is modular and portable, which means it goes into the QC laboratory for verification and qualification work and onto the production floor for in-process and release testing without a different instrument for each room. The test components are optimized for high-sensitivity applications and the high-resolution requirements of the pharmaceutical industry.

The operator works from a touch screen display that shows the test data and the machine operations in plain terms. For a changeover, that is the interface you want: no separate control room, no training cycle just to read the result.

Setting the limit the test is compared against

A leak test is only as defensible as the limit it is measured against. Under ASTM F2338, the acceptance limit is established during method development for the specific package format: the method is qualified on the format, the leak rate at which the method reliably detects is characterized, and that value becomes the criterion every subsequent run is judged by. The MFT-600 gives you the leak rate as a number, so the comparison is a documented pass or fail rather than an operator's impression of a reading.

Because the method is non-destructive and quantitative, the same instrument can carry the program from method development, through in-process checks, to release testing. One documented method set, one record trail, and the format you tested is the format that ships. That is the value of a deterministic physical method over a destructive or probabilistic one: every package is answered, and the answer is the same kind of number every time.