MedIntegrity MFT-1000 Manufacturer & Supplier

Notes From Our Technical Documentation

Model Information & Core Product Description

Model:MFT-1000 The Medintegrity MFT-1000 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-1000 Packaging Leak Tester technology utilizes the ASTM vacuum decay leak test method (F2338-09) & pressure decay method recognized by the FDA as a consensus standard for package integrity testing to deliver highly accurate results. The modular, portable design of the MFT-1000 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.

Applicable Package Types

Chamber Multiple Package Type·Syringes·Vials·Filled & sealed bottles & cups·Ampoules·Non-porous pouches·BFS containers·Ophthalmic dropper bottles

Technical Specifications

Measurement Method is Vacuum Decay & Pressure Decay Instrument Dimensions is 430mmx655mmx420mmx330mmWeight is 51Kg(Net)Primary Power is AC100~240V 50~60HzElectronic Testing Record is Yes

Technical Guide

Two decay methods in one instrument

The MFT-1000 carries both the vacuum decay method and the pressure decay method. Vacuum decay seals the package into a test volume, brings the volume to a set level, and reads the leak from the time-based pressure change — the ASTM F2338 route, the FDA-recognized consensus standard for package integrity testing. Pressure decay works from the other side of the balance: the volume is pressurized, and a leak shows up as pressure falling over time. Together the two methods cover the full range of sealed rigid and flexible formats in a pharmaceutical plant.

Both methods are deterministic in the USP <1207> sense — a direct pass/fail against a defined criterion, reproducible and predictable, at low detection limits. With the capability to detect leak rates as low as 2 microns depending on package specifications, the instrument gives you a quantitative answer you can trend across a production campaign and stand behind at audit.

The chamber decides how many formats you can run

The multiple package type chamber is where the MFT-1000 earns its place: syringes, vials, filled and sealed bottles and cups, ampoules, non-porous pouches, BFS containers and ophthalmic dropper bottles, all in one instrument. When a site runs several formats, that means one documented method set and one audit trail instead of a different instrument per format.

The test components are optimized for high-sensitivity applications and the high-resolution requirements of the pharmaceutical industry, and the operator touch screen display shows the test data and the machine operations without a separate control station.

Built for the release line

At 51 kg net with a footprint of 430 × 655 × 420 × 330 mm, this is a fixed installation for the release area rather than a portable. Power is AC 100–240 V at 50–60 Hz, the instrument qualifies to GMP, and it stores results as electronic testing records — the release test result is a record from the moment it is made.

The life-cycle framing from USP <1207.1> applies directly: integrity verification across development and validation of the product-package system, manufacturing, and shelf-life stability, with ISO 11607 / 11608 covering the sterile barrier packaging around it. One instrument, one method set, and the record trail that ties the three phases together.

The multi-format chamber in daily operation

The multiple package type chamber is where the 1000 earns its fixed-installation place. A site that runs syringes, vials, bottles and cups, ampoules, non-porous pouches, BFS containers and ophthalmic dropper bottles is not going to keep a benchtop for every one of them; the 1000 covers them with a chamber set that changes per format — swap the chamber and the fixture for the format in hand, not the instrument, not the method, not the procedure.

For the release area that is the real saving: one fixed installation, one documented method set, and one audit trail across every format the site ships. Changeover is a chamber change, and the electronic record and the compliance documentation stay the same regardless of which format is in the chamber — which is exactly what a multi-format release line needs to keep its paperwork as fast as its production.