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ASTM F2054 Burst Strength Testing

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 assist with finding solutions. Keystone provides comprehensive reports shortly after the completion of the testing.

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 is around a flexible package that is internally pressurized and enclosed with restraining plates. This burst test will increase the pressure of the package until the seal bursts. Restraining plates serve to stabilize the product and ensure that pressure is distributed evenly.

Uniform pressure distribution will help to identify the weakest point in the seal. This procedure applies to flexible packages with seals around the perimeter (pouches). It is also applicable to pouches with a peelable seal feature.

Scope of ASTM Testing of Package Seals Using Internal Air Pressurization

The packages are tested in an apparatus that applies pressure internally until the seal ruptures (bursts). The package is placed between two parallel plates, restraining plates, that add rigidity to the package. This prevents the package from expanding but leaves the seal edge free. An internal sensor will monitor the pressure as it increases throughout the test. Two configurations may be used for this test method depending on the application:

  • Open Package Configuration – the seal is placed around three sides of the package and the fourth side is left open
  • Closed Package Configuration – the seal is placed around all four sides of the package

This test indicated tendencies for seal failure when the package is exposed to different pressures. In the field, pressure differentials are common during sterilization and transportation. It is important to note that this test’s purpose is for the seal’s burst strength.

ASTM F2054 cannot make any determinations of overall package strength or areas of the package that touch the restraining plates. However, burst leak integrity testing can be used to evaluate seal strength during manufacturing and various points of distribution.

Open-Package Test:

For this ASTM F2054 test method, the package is sealed on three sides and one side remains unsealed. It is placed in the testing apparatus and then the open side is sealed by a clamping mechanism. The pressurization testing nozzle is placed in the open end of the package before it is clamped.

Test an appropriate number of samples so that an accurate determination can be made of the representative performance. The package should be conditioned for a minimum of 72 hours before the start of testing. It is best if the test is conducted within the conditioned environment. 

Regardless, if this is not possible, the report should specify the conditions at the time of testing. It is recommended to mark the sample packages so that they are all positioned 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, the package is sealed on all four sides and placed 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. The package should be conditioned for a minimum of 72 hours before the start of testing.

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.

The packages should be inspected 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 write a comprehensive report that follows the guidelines provided by ASTM F2054.

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 adhering to 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:

 

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.