ASTM F2338

Non-Destructive
Vacuum Decay Leak Test Method
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ASTM F2338

Standard Summary

ASTM F2338 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method specifies a non-destructive technique for detecting leaks in sealed packages through vacuum decay testing. This standard is widely applied in industries where product integrity is critical, such as pharmaceuticals, medical devices, biologics, და საკვების შეფუთვა. The vacuum decay method is sensitive enough to detect micro leaks, providing a reliable way to ensure package integrity without damaging the test sample. It is particularly useful for sterile packaging that requires a secure barrier to prevent contamination.

Vacuum Leak Method for Micro Leak Testing Machine MLT-01
Vacuum Leak Rate Profiles and Test Stages

Test Theory

The vacuum decay method is a highly sensitive, non-destructive testing method that works by detecting pressure changes when a vacuum is applied to a sealed package. Micro leaks in the package lead to measurable changes in the internal vacuum level. These changes are recorded and analyzed to detect the presence and size of leaks.
This test is critical for detecting defects as small as 0.2 µm in rigid and flexible packages used in the pharmaceutical and medical device industries, where maintaining sterility is crucial.

Principle and Test Process

Utilizing dual sensor technology, the vacuum decay method operates on the principle of a dual circulation system. The primary unit of the vacuum decay leak detection tester is linked to a custom-designed test chamber intended for accommodating the package under scrutiny. The apparatus evacuates the test chamber, establishing a pressure differential between the interior and exterior of the package. Subsequently, due to this pressure variance, gas within the package migrates into the test chamber via any existing leaks. The dual-sensor technology monitors the correlation between time and pressure, subsequently comparing it against predetermined standard values to ascertain the presence of any leaks in the sample.

  • 1. FILL: Secure the sample in the MLT-01 Micro Leak Tester's chamber and apply negative pressure.
  • 2. SETTEL: When the desired negative pressure is reached, the SETTLE stage begins to accommodate component stretching or flexing.
  • 3. TEST: After settling, the vacuum decay TEST phase starts, measuring any pressure increase.
  • 4. VENT: In the VENT stage, release remaining negative pressure to the atmosphere.
  • Judgment:Pressure compression with non-leak samples and system judges PASS or FAIL.

MLT-01 მიკრო გაჟონვის ტესტერი

For implementing ASTM F2338, advanced vacuum decay leak testers such as Cell Instruments MLT-01 მიკრო გაჟონვის ტესტერი offer precise measurement and analysis capabilities. Equipped with sensitive vacuum sensors and a real-time data collection interface, this model provides unmatched accuracy in detecting even the smallest micro leaks.

ASTM F2338 Vacuum Decay Leak Tester
MLT-01 Micro Leak Tester​

Key Features

High Sensitivity

Detects micro leaks as small as 0.2 µm.

Non-Destructive

Ensures packages remain intact for further use or testing.

Real-Time Monitoring

PLC-controlled with touch screen operation for ease of use.

Versatile Applications

Suitable for a wide range of packaging materials, including blister packs, vials, ampoules, and flexible pouches.

Why Choose the MLT-01 Micro Leak Tester?

Advanced Testing Mechanism

With its high-sensitivity sensors and state-of-the-art vacuum decay technology, the MLT-01 offers precise detection of micro leaks that compromise package integrity.

Regulatory Compliance

Perfectly aligns with ASTM F2338 requirements for pharmaceutical and medical packaging integrity testing.

User-Friendly Interface

Equipped with a PLC-controlled system and touch screen interface, it simplifies testing operations for laboratory and production line use.

Long-Term Value

The non-destructive nature of vacuum decay testing means you can use the same package for additional tests, offering a cost-effective solution for high-value product testing.

What does ASTM F2338 mean to industries?

The significance of ASTM F2338 lies in its non-destructive nature and high sensitivity to micro leaks, making it ideal for industries like pharmaceuticals and medical devices. This test ensures the sterility and integrity of packaging used for sterile products, helping companies comply with regulatory standards such as those from the FDA and EMA.

Regulatory Compliance

Companies in the pharmaceutical and medical device sectors must meet strict packaging integrity requirements to ensure that products remain sterile and safe for use.

Cost-Effectiveness

Since the test is non-destructive, manufacturers can reuse the tested packages, reducing material waste.

Wide Applicability

ASTM F2338 can be applied to both flexible and rigid packages, ensuring versatility across a wide range of packaging formats.

Data-Driven

With real-time monitoring and precise data collection, it offers actionable insights into packaging performance and helps in continuous quality improvement.

FAQ about ASTM F2338

ASTM F2338 defines the vacuum decay method for non-destructive detection of micro leaks in sealed packaging, widely used in the pharmaceutical and medical industries.

Yes, ASTM F2338 is applicable to both flexible and rigid packaging formats, including blister packs, vials, ampoules, and flexible pouches.

Vacuum decay testing is more sensitive, offering detection of micro leaks that traditional methods like bubble testing may miss. Additionally, it is faster, non-destructive, and offers real-time data monitoring.

Yes, with advanced testing equipment like the MLT-01, the entire process can be automated for high-throughput environments, ensuring consistent results.

This method can detect leaks as small as 0.2 µm, making it extremely sensitive and ideal for ensuring the integrity of sterile packaging.

Non-destructive testing preserves the tested package, allows for additional tests on the same sample, and minimizes waste, making it both cost-effective and sustainable.

The primary industries benefiting from ASTM F2338 include pharmaceuticals, medical devices, biologics, and food packaging, where maintaining product integrity is paramount.

Common defects include micro holes, seal failures, and pinhole leaks in packaging that can lead to loss of sterility.

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