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Package Integrity Testing

Package integrity testing is critical for determining the sterility and shelf life of a product. Components of package integrity testing include evaluation of vacuum leaks, bubble leaks, and other assessments of sterile barrier integrity.

Package integrity testing services. Sterilizing tools. Technician in gloves putting bags in sterilizer

Dye Penetration Testing

Sterilized medical device packages and other packages can be tested for seal leaks through dye penetration testing. The first and most common method for dye penetration testing is the injection method. For the injection method, dye solution is injected to cover the longest package edge to a depth of 1/4 inch. Following administration of the dye, the seal area is visually examined through the transparent side of the package. Any channels in the seals will be readily detected by the technician within five seconds. This process is then repeated for the remaining sides of the package. This test is carried out according to ASTM standards.

Peel Strength Testing

Peel strength testing ensures that your packaging is capable of providing (and maintaining) a sterile barrier for your product by evaluating packaging for modes of seal failure. To perform peel strength testing, seal test specimens are prepared by cutting slips of packaging material such that edges are clean-cut and perpendicular to the direction of the seal. Next, the sealed area of the specimen is centered between grips on a tensile testing machine such that the seal line is perpendicular to the direction of pull. The seal is then tested at a set rate of grip separation until failure. The maximum force encountered as the sample is stressed to failure and the mode of failure is recorded. Both peel force and seal strength can be determined depending upon the mode of seal failure. This test is carried out according to ASTM standards.

Bubble Emission Testing

Bubble emission tests for large leaks in flexible packaging under vacuum. For bubble emissions testing, the sealed package is fully submerged in a fluid within a vacuum chamber. Next, the cover on the vacuum chamber is set and the vacuum is turned on. The vacuum level chosen is as large as possible to create maximum sensitivity for the test. The vacuum is held for around 30 seconds during which time the submerged specimen is examined for leaks via air bubble emissions. The vacuum is then released, and the package is examined for any test fluid leaks inside the sterile barrier system. This test is carried out according to ASTM standards.

Accelerated Aging

Accelerated aging stability testing involves storing samples at an increased temperature to simulate real time aging in a shorter amount of time. Thus, initial stability testing can be performed in a shorter amount of time. Stability testing, such as accelerated aging, is necessary to prove product shelf life, as package integrity is lost over time as packaging materials or adhesives degrade.  

Accelerated aging techniques are based on the assumption that materials deteriorate following the Arrhenius reaction rate function. With the Arrhenius function, every 10°C increase or decrease in temperature results in a 2x increase in the rate of deterioration. Thus, you can half the time of your stability testing for every 10°C increase in temperature that the products are stored. This test is carried out according to ASTM standards.

Our Tests

M800

Package Integrity – Accelerated Aging Q10 Coefficient (FDA) Method

M801

Package Seal Integrity – Peel Strength, ASTM Method, per seal/pull

M802

Dye penetration/migration with or without surfactant, per package

M803

Shelf-Life Stability Sterility Test accelerated aging, 10 samples per time interval

M804

Shelf-Life Stability Sterility Test, real-time expiration dating

M805

RODAC Agar Method Assessment Of Porous Material

M806

Vacuum Challenge Method of porous material

M806A

Closure Test Method of porous material

Sample Submission

Purchase Order

In line with current ISO/QSR purchasing requirements, all orders should be sent with a signed completed Purchase Order. This will help expedite the processing or your order. Standing Purchase Orders will be gladly accepted for routine continuing orders.

Sample Submission Form

Please download and fill out a Test Request Form for each sample/test submitted. Identify each submission clearly and completely. Please be specific with the description, Lot Number, PO etc. and specify the test desired. Please indicate the Test Code Number on the form also. This will greatly reduce turnaround time necessary to generate an accurate, final report.

Final Reports

Upon completion of test, a final report will be issued and all records and raw data will be held for five years.