ASTM D3078

Comprehensive Overview of
– The Most Used Package Leak Testing Method

Standard Summary

ASTM D3078, name as Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission, is an established standard that provides guidelines for the leak testing of packaging materials and systems using a vacuum method. This standard is crucial for industries where the integrity of packaging directly affects product quality and safety, particularly in pharmaceuticals, food, cosmetics, beverage and medical device sectors. The leak tester described in ASTM D3078 helps manufacturers ensure that their packages maintain a hermetic seal, thereby preventing contamination, degradation, and product failure.

The purpose of ASTM D3078 is to outline a systematic approach for testing the effectiveness of seals in packaging systems. This is critical for maintaining the shelf life of products and ensuring consumer safety. 

 

Standard Description

ASTM D3078 focuses on the theory, process, and methodology of testing package integrity using vacuum leak testing techniques. 

It covers the determination of gross leaks in fexible packaging containing a headspace gas. Test sensitivity is limited to 1×10-5 atm cm3/s (1×10-6 Pa m3/s) or even less sensitive.

Bottle Vacuum Leak Test

Test Theory

The fundamental principle behind ASTM D3078 is the application of a vacuum to the package being tested. By creating a controlled low-pressure environment around sample, the test detects any leaks that forms air bubbles in water. The theory posits that if a package is airtight, it will not allow air to escape during the vacuum application phase. Conversely, any sign of air bubble indicates a leak, making the test an effective method for evaluating packaging integrity.

ASTM D3078 Bubble Leak Test

Detailed Description of the Test Process

Il vacuum leak testing process outlined in ASTM D3078 involves several key steps:

LT-02 Tester di tenuta

The first generation of automatic leak tester designed by CELL Instruments, which is the most sold units so far.​

LT-03 Tester di tenuta Piccolo

LT-03 Tester di tenuta

The latest auto leak tester that is still evolving, with advanced control system, display, and optional printing and software features.

Testing Equipment

For effective leak detection as per ASTM D3078, using a reliable leak tester is essential. The Cell Instruments LT series Vacuum Leak Testers, especially LT-02 and LT-03 Leak Tester, serve as a model representative of this standard.

Result Expression

Results from the vacuum leak test performed under ASTM D3078 are typically expressed in terms of:

Vacuum Level

The vacuum level used during the test, which indicates the leak condition.

Time Duration

The time taken for the pressure to hold, if applicable, which can provide insights into the severity of the leak.

Pass/Fail Criteria

Based on whether the package maintained the required vacuum level throughout the test duration.

Packages that demonstrate a stable pressure profile without showing streams of bubbles or restores to its original shape are considered to pass the leak test, confirming their integrity.

Significance of ASTM D3078 Standard

The significance of ASTM D3078 in the packaging industry cannot be overstated. Ensuring package integrity is essential for several reasons:

Product Safety

In the pharmaceutical and food industries, a leak can lead to contamination, compromising consumer safety. Maintaining a hermetic seal helps prevent exposure to harmful substances.

Shelf Life and Quality

Many products, especially those sensitive to moisture and oxygen, require airtight packaging to maintain their efficacy and shelf life. ASTM D3078 helps ensure that packaging meets these requirements.

Regulatory Compliance

Adhering to ASTM D3078 can assist manufacturers in meeting regulatory standards set by organizations such as the FDA and ISO, ensuring that their products can be marketed without issues related to packaging failures.

Cost Savings

Identifying and addressing leaks before products reach consumers can save companies significant costs associated with product recalls, customer dissatisfaction, and potential lawsuits.

FAQ about ASTM D3078

This standard is applicable to a wide variety of packaging materials, including plastics, glass with seals and caps, and metal.

The test duration can vary based on the specific packaging and requirements outlined in ASTM D3078, typically ranging from a few minutes to several hours.

Common causes include faulty seals, manufacturing defects, and material degradation over time.

Industries such as pharmaceuticals, food and beverage, and medical device manufacturing frequently use this standard to ensure product integrity.

The vacuum chamber is a transparent container capable of withstanding approximately one atmosphere pressure differential, fitted with a vacuum-tight cover. The chamber is connected to vacuum source, as well as a vacuum reading system. 

It will have a lid that can seal the chamber airtight, part of the lid is a porous plate that can keep a floating sample submerged in water.

In ASTM D3078 method, a steady progression of bubbles from the flexible container is considered as leak, while isolated bubbles caused by entrapped air are not considered as leaks.

1. If there are bubbles definitely attributable to leaks in a specimen during the rise of vacuum, or when held at full vacuum, the specimen fails the test.
2. If test fluid attributable to a leak is inside a specimen, the specimen fails the test.

While primarily designed for packaging, it can also be adapted for testing containers or systems that require airtight seals.

No, it is a non-destructive test that allows packages to remain intact while still assessing their integrity.

Analyzing the testing process and inspecting manufacturing conditions, and locate where the leak happens can help identify and rectify issues leading to leaks.

Yes, many modern vacuum leak testers, including the LT-03 Tester di tenuta, can be integrated into automated production lines for enhanced efficiency.

Leak is any opening in a flexible package that, contrary to intention, either allows the contents to escape or substances to enter.

No, flexible packaging with little or no headspace cannot be reliably evaluated with this test method.

If there are no bubbles observed attributable to leaks, and if no test fluid attributable to a leak is inside a specimen, the specimen passes the test.

Looking for reliable ASTM D3078 leak detection equipment?

 Don’t miss out on the chance to optimize your quality control processes with state-of-the-art equipment.

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