MedIntegrity MFT-800 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-800 uses the ASTM F2338 vacuum decay method: the package is sealed into a test volume, the volume is brought to a set level, and the instrument watches the pressure. An intact package holds; a leaking one loses gas volume over time. Using the ideal gas law and introducing time to establish a rate of change of the gas volume lost to leakage, a relationship of the pressure change in the system volume can be derived — that relationship is your leak rate.

F2338 is the FDA-recognized consensus standard for package integrity testing, and the MedIntegrity technology was used in developing the method itself. The output is a quantitative result against a defined acceptance limit, not a visual call.

Deterministic, in the USP <1207> sense

In 2016, USP issued guidance USP <1207>, <1207.1> and <1207.2> on container closure integrity testing, and the position is clear: deterministic methods are preferred over probabilistic methods because they achieve reproducible and predictable results at low detection limits. Vacuum decay is a deterministic method — every package is tested, every package gets an answer, and the answer is the same kind of number every time.

USP <1207.1> also frames where the testing belongs in the product life cycle: package integrity verification occurs during at least three phases — the development and validation of the product-package system, product manufacturing, and commercial product shelf-life stability. The idea is that container closure integrity is built into the design of the product-package system and the processes that yield it. ISO 11607 and 11608 carry the related requirements for sterile barrier packaging materials and systems.

Where it runs and what it logs

At 19 kg net and 311 × 480 × 280 × 190 mm, the MFT-800 is a benchtop instrument for the QC laboratory and the line-side QC area. It runs on AC 100–240 V at 50–60 Hz, so the power question does not change between sites. Operating humidity is 25–60%, storage 5 to 50 °C at 25–90% without condensation.

On the pressure side, the ranges cover -0.1 to 0.2 MPa, -0.1 to 0.7 MPa and -0.1 to 1.0 MPa — the spread needed across seal strengths of different formats. The minimum detectable hole is 1.5 to 2 µm per the specification.

Data memory holds over five years, the audit trail is sized for five years or more with quick retrieval by time, and the communication set is Ethernet, USB and RS485 — the record leaves the instrument in the shape your LIMS or quality system wants it. The instrument qualifies to GMP.

Where the acceptance limit comes from

The output of a vacuum decay test is a leak rate, not a yes or no. In method development, the limit is set against known references: sealed packages and deliberately compromised ones at defined hole sizes, so the instrument's response to each is measured first. The acceptance limit is then placed inside that response window — tighter than the smallest deliberate compromise and looser than the intact seal — leaving a judged zone in between where a real result can fall and be decided.

Once that limit is written into the procedure, it does not move. Every production batch is measured with the same rule, which is the value of a deterministic method: the ruler (the method and the limit) is fixed, the number (the leak rate) is comparable, and the result holds across batches and across time instead of shifting with the tester's judgment.

From method development to release, one method set

USP <1207> draws the line that shapes how this instrument is used: deterministic methods are preferred over probabilistic ones because they give reproducible and predictable results at low detection limits, and vacuum decay sits squarely on that side. The practical effect is that the same documented method can serve the three phases <1207.1> names — development and validation of the product-package system, product manufacturing, and commercial shelf-life stability — without a different instrument or a different record format for each phase.

The MFT-800's 1.5 to 2 µm minimum detectable hole, the -0.1 to 1.0 MPa pressure range, and the five-year-plus data and audit-trail memory are sized for exactly this life-cycle use. The result is a container closure integrity program where the development record, the in-process record and the release record are the same kind of record, which is how auditors like to read them.