No. For rigid containers, refer to (vacuum testing of rigid containers) or ASTM D3079 (dry testing). D3078-21 explicitly covers flexible and semi-rigid pouches.
For the pharmaceutical and medical device sectors, the choice of test method is often dictated by regulatory guidance such as FDA CFR 21 Part 820 or ISO 11607 (Packaging for terminally sterilized medical devices).
ASTM D3078-2021 has been harmonized with international standards, particularly ISO 23867-2 ( Leak test method for flexible packaging — Part 2: Bubble test ). This helps global manufacturers maintain compliance across regions. astm d3078 pdf 2021
The presence of bubbles in sealants can affect their performance, adhesion, and overall quality. Bubbles can lead to reduced sealant effectiveness, increased permeability, and compromised durability. By using ASTM D3078, manufacturers, specifiers, and users of sealants can ensure that the products meet the required standards for bubble-free performance.
The 2021 revision (designated D3078-21) introduced several clarifications and technical updates compared to the previous 2018 or 2014 versions. When you acquire the , you will notice the following key updates: For the pharmaceutical and medical device sectors, the
: A transparent vacuum chamber, vacuum pump, and immersion fluid (usually water). Primary Use
The latest version of the standard is ASTM D3078-02(2021)e1 , which was reapproved in 2021. This standard defines the Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission . Key Documents and Links The presence of bubbles in sealants can affect
The revised standard clearly states that this method is intended for – typically >250 µm in diameter. It is not a substitute for high-sensitivity methods like vacuum decay or dye penetration tests for micro-leaks.