Common ASTM Standards for Package Testing | MDC Engineering, Inc.

ASTM Test Standards

Each of our HFFS Packaging machines are designed, built and validated to meet the stringent requirements for terminally sterile packaging applications. To this end we keep abreast of the various ASTM test standards and ISO stds that effect our customers.

ASTM Test Standards

The scope of the ASTM Test Standards is the promotion of knowledge in, and the development of standards for packaging. Standards shall include terminology, practices, test methods, specifications, guides, and classifications (including dimensions).
This work specifically includes:
1) defining materials and processes that consider both item and consumer impact; the result being a package and packaged product that are acceptable for delivery,
2) generating closely related shipping systems design criteria,
3) developing materials handling standards related to distribution, including measurement of the packaging environment,
4) assessing the suitability of packaging related standards through round-robin laboratory evaluations, quantitative testing and instrumentation applications, and,
5) establishing standards on reuse, recycling and disposal of materials related to packaging.
Efforts involving tests on materials where basic research is addressed within other committees shall be closely coordinated with those relevant ASTM committees. In the process of standards development, recognition shall be made of related national and international standards with the encouragement of full participation in those activities.

D3078-02 – Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission

D4991-94 – Standard Test Method for Leakage Testing of Empty Rigid Containers by Vacuum Method

D6653-01 – Standard Test Methods for Determining the Effects of High Altitude on Packaging Systems by Vacuum Method

F1140-07 – Standard Test Methods for Internal Pressurization Failure of Unrestrained Packages

F1886-98 – Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection

F1929-98 – Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration

F2029-00 – Standard Practices for Making Heat seals for Determination of Heat seal-ability of Flexible webs as Measured by Seal Strength

F2054-07 – Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates

F2096-11 – Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test) using a Leak Tester. The internal pressurization test method provides a practical way to examine packages for gross leaks. This test method is extremely useful in a test laboratory environment where no common package material/size exists. This test method may apply to large or long packages that do not fit into any other package integrity test method apparatus.

This test method may be used to detect substrate holes and channels. This test method covers the detection of gross leaks in packaging. Method sensitivity is down to 250 ?m (0.010 in.) with an 81 % probability (see Section 11). This test method may be used for tray and pouch packages.

F2097-07 – Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

F2559-06 – Standard Guide for Writing a Specification for Sterilizable Peel Pouches

F88-07 – Standard Test Method for Seal Strength of Flexible Materials.

For more information on the above referenced package integrity testing standards please visit