MedIntegrity MFT-900 Manufacturer & Supplier

Notes From Our Technical Documentation

CCIT Regulatory Guidance & Data Integrity and Compliance

MedIntegrity technologies were used to develop ASTM F2338 Test Method (Vacuum Decay). The vacuum decay method of leak testing is a physical measure of package integrity which FDA recommended. Using the ideal gas law and introducing time to establish a rate of change of gas volume lost to leakage, a relationship of changes in pressure in the system volume can be derived. FDA Recognized Consensus Standards: ASTM F2338 Vacuum Decay Test Method for package integrity testing. As the driving forces behind safety evaluation of materials and container closure systems in the US, the United States Pharmacopeia (USP) and Food and Drug Administration (FDA) enforce stringent requirements for Container Closure Integrity Testing (CCIT). In 2016, USP issued guidance USP<1207>; <1207.1> and <1207.2> that deterministic methods are preferred over probabilistic methods because they are able to achieve reproducible and predictable results at low detection limits for CCIT. In the current version of USP <1207>, there are a total of four subsections. USP <1207.1> discusses critical background information and rationale for the selection of an appropriate test method. Included in this subchapter is a detailed discussion of container closure integrity testing and evaluation during a product life cycle, which states: Package integrity verification occurs during [at least] three product life cycle phases: 1) the development and validation of the product-package system, 2) product manufacturing, and 3) commercial product shelf-life stability assessments". The idea behind such a statement is that container closure integrity should be built into the design of the product-package system and the processes that yield it. ISO 11607 AND 11608 regulatory guidance documents related to sterile barrier packaging Requirements for materials and packaging systems. NOTE:The information and specifications in this document are subject to change without notice.

Technical Guide

How vacuum decay reads a package

The MFT-900 runs the ASTM F2338 vacuum decay method: the package is sealed into the test volume, the volume is brought to a set level, and the instrument watches the pressure. An intact package holds the volume constant; a leaking one loses gas over time. The ideal gas law, with time introduced to establish the rate of change of the gas volume lost to leakage, turns that pressure change into a quantified leak rate.

F2338 is the FDA-recognized consensus standard for package integrity testing, and the MedIntegrity technology was used in developing the method. The result is a number against a defined acceptance limit — reproducible, predictable, and the same kind of result every run, which is what 'deterministic' means in this context.

Deterministic, in the USP <1207> sense

USP <1207>, issued in 2016 together with <1207.1> and <1207.2>, sets the framework for container closure integrity testing, and its position is that deterministic methods are preferred over probabilistic methods — reproducible and predictable results at low detection limits. Vacuum decay sits squarely on that side of the line: every package tested, every package answered, every answer the same kind of number.

The life-cycle framing in <1207.1> is worth knowing when you plan the program: package integrity verification spans the development and validation of the product-package system, product manufacturing, and commercial shelf-life stability. Integrity is built into the design of the product-package system and the processes that yield it — and ISO 11607 / 11608 carry the requirements for the sterile barrier packaging materials and systems around it.

Where it runs and what it logs

At 32 kg net and 430 × 655 × 420 × 330 mm, the MFT-900 is a laboratory workstation instrument for QC and release testing. Power is AC 100–240 V at 50–60 Hz, so it moves between sites without a power question; operating humidity is 25–60%, storage 5 to 50 °C at 25–90% without condensation.

The pressure ranges — -0.1 to 0.2 MPa, -0.1 to 0.7 MPa, -0.1 to 1.0 MPa — span the seal strengths across formats, and the minimum detectable hole is 1.5 to 2 µm per the specification.

On the documentation side: data memory of over five years, an audit trail of five years or more with quick retrieval by time, and communication over Ethernet, USB and RS485. The record leaves the instrument in the shape your LIMS or quality system needs it in, and the instrument qualifies to GMP.

Batch-by-batch, at the release workstation

Release testing is a batch affair. A lot is dozens to hundreds of packages, and each one has to be checked before the lot is cleared. As the laboratory workstation of the MFT line, the 900 runs the lot the way release work requires: packages go into the test volume one at a time, each gets its own leak rate, and the record groups the results under the lot rather than scattering them.

The grouping is the point. A release decision has to trace to every package in the lot, and the record that supports it shows the full distribution of leak rates — not just the average. An average can hide an outlier; the per-package record cannot. That is the difference between a lot that is cleared because its mean looks fine and a lot that is cleared because every piece of it held.

In-process and release on one platform

A release-line instrument earns its place when it can do the in-process work and the release work without a hand-off that loses information. The MFT-900 is sized for that: a 32 kg benchtop workstation with the -0.1 to 0.2 / 0.7 / 1.0 MPa pressure range and the 1.5 to 2 µm detection floor, so the same documented vacuum-decay method covers the in-process checks during the run and the release test at the end of it, with the same record format from first run to last.

The deterministic character is the point, in the USP <1207> sense: every package tested, every package answered, every answer the same kind of number. Across the five-year-plus data memory and audit trail, with export over Ethernet, USB or RS485, the campaign's integrity record is something you can pull and read in one place rather than reconstruct from several. That is what keeps a multi-format line readable as one program.