ASTM F2054 Burst Testing of Package Seals Using Internal Air Pressurization
ASTM F2054 burst testing of package seals determines the minimum burst strength of a seal. As an ISTA and ISO 17025 certified lab, we realize the importance of burst testing. Meeting the ASTM F2054 requirements can be difficult. We understand the challenges and guide companies through the process.
Keystone Package Testing partners with customers to achieve package compliance. We are in constant communication throughout the test process. When packages do not meet the requirements, our engineers help find solutions. Keystone provides comprehensive reports shortly after testing concludes.
Request a quote to receive testing services customized to your specific needs. Have a question about internal air pressurization? Contact us and we will determine the best course of action.
Summary of ASTM F2054 Burst Integrity Testing
The seal surrounds a flexible package while technicians apply internal pressurization and enclose it with restraining plates. This burst test increases package pressure until the seal bursts. Restraining plates stabilize the product and distribute pressure evenly.
Uniform pressure distribution helps identify the weakest point in the seal. The procedure also applies to pouches with a peelable seal feature.
Scope of ASTM Testing of Package Seals Using Internal Air Pressurization
The test apparatus applies internal pressure to packages until the seal ruptures (bursts). Technicians place the package between two parallel restraining plates that add rigidity. This prevents the package from expanding but leaves the seal edge free. An internal sensor monitors pressure as it increases throughout the test. This test method uses two configurations depending on the application:
- Open Package Configuration – technicians place the seal around three sides of the package and leave the fourth side open.
- Closed Package Configuration – technicians place the seal around all four sides of the package.
This test indicates tendencies for seal failure when packages experience different pressures. In the field, pressure differentials are common during sterilization and transportation. This test focuses specifically on seal burst strength.
ASTM F2054 cannot make any determinations of overall package strength or areas of the package that touch the restraining plates. However, manufacturers use burst leak integrity testing to evaluate seal strength during manufacturing and distribution.
Open-Package Test:
Technicians seal the package on three sides and leave one side unsealed. Technicians place the package in the testing apparatus and seal the open side using a clamping mechanism. Technicians place the pressurization testing nozzle in the open end of the package before clamping it.
Test an appropriate number of samples to make an accurate determination of representative performance. Condition the package for a minimum of 72 hours before testing begins. Conduct the test within the conditioned environment whenever possible.
Regardless, if this is not possible, the report must specify testing conditions. Mark the sample packages so technicians position them the same way for consistent testing. Begin inflating the package by increasing internal pressure until the package bursts as a result of pressurization.
Closed-Package Test:
For the closed-package test, technicians seal the package on all four sides and place it between the restraining plates. The pressurization nozzle is inserted through a puncture in the body of the package but shall maintain an airtight seal around the nozzle.
Test an appropriate number of samples so that an accurate determination can be made of the representative performance. Condition the package for a minimum of 72 hours before testing begins.
It is best if the test is conducted within the conditioned environment. If this is not possible, the report should specify the conditions at the time of testing. Begin inflating the package by increasing internal pressure until the package bursts as a result of pressurization.
Inspect the packages to identify where the rupture occurred. If the rupture occurred in a place other than the seal, the test sample may be voided. The testing laboratory will produce a comprehensive report that follows ASTM F2054 guidelines.
Significance of ASTM F2054 Burst Testing
First and foremost, the primary objective of ASTM F2054 is to evaluate the performance of sealed pouches. By conducting burst testing according to ASTM F2054, manufacturers can ensure that their pouches meet the required strength standards and minimize the risk of package failure.
Medical devices require packaging that maintains their sterility and protects them from external contaminants throughout their lifecycle. A burst in the packaging can compromise the sterility of the devices, rendering them ineffective or potentially harmful when used on patients.
Additionally, regulatory bodies such as the FDA impose stringent guidelines and standards to ensure the safety and effectiveness of medical devices. By following this standard, manufacturers can demonstrate compliance with regulatory requirements, enhancing the confidence of regulatory authorities, healthcare professionals, and end-users in the product’s safety.
Expert Laboratory Burst Testing of Package Seals
Keystone Package Testing is proud to provide customers with reliable testing and reports. Keystone is the right package testing partner with an international accreditation, competitive pricing, and quick turnaround time.
Our package testing engineers are experienced and have a thorough knowledge of industry standards. They are prepared to guide you through the transit testing process. Let’s get started! Request a quote or contact us at (724) 657-9940.
For more referenced ASTM standards and similar testing, please follow the links below:
- ASTM E171 Practice for Conditioning and Testing Flexible Barrier Packaging
- ASTM E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
- ASTM F17 Terminology Relating to Flexible Barrier Packaging
- ASTM F88 Seal Strength Testing of Flexible Barrier Materials
- ASTM F1140 Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
Interested in the EMC/EMI, climatic, dynamic, shielding effectiveness, or IP Code testing of a product? Follow the corresponding links or www.keystonecompliance.com for more information.