DDL

Medical Device Package Testing

Home / Medical Device Package Testing

DDL Receives ISO/IEC 17025 Accreditation

DDL is pleased to announced its Eden Prairie, MN and Fountain Valley, CA facilities have received ISO/IEC 17025:2005 accreditation from the American Association for Laboratory Accreditation (A2LA).

ISO/IEC 17025:2005 is the international standard by which a laboratory’s commitment to quality and technical competence are evaluated. DDL achieved ISO/IEC 17025:2005 accreditation by demonstrating its laboratories are in compliance with the standard and A2LA accreditation requirements. This accreditation covers distribution testing, and strength and integrity testing.

“Receiving accreditation for our laboratories demonstrates to our customers that we continue to adhere to the highest level of quality assurance,” said Corey Hensel, General Manager, DDL, Inc. “Combined with our recently renewed ISO 9001:2008 certification, the ISO/IEC 17025:2005 accreditation validates DDL’s commitment to continuously improving our quality program in an effort to offer superior service within our industry.”

“ISO/IEC 17025: 2005 is becoming an essential standard for testing facilities serving the medical device industry,” said Patrick Waddick, Quality Assurance Manager, DDL, Inc. “This accreditation further reaffirms our technical competency and capability to produce precise and accurate test data that our customers can rely upon to meet their regulatory requirements.”

Please visit www.testedandproven.com/about-ddl/certifications/ to download a copy of DDL’s ISO/IEC 17025:2005 accreditation.

Accelerated Aging: Abusing the Time Machine

At the heart of ASTM F1980 “Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices” are the Arrhenius equation and Accelerated Aging Factor (AAF) Determination (Sections 6 and 7). Practical use of the AAF involves choosing an aging factor (Q10) which is typically a value of two (2) for packaging testing, an ambient temperature and an accelerated aging temperature. The typical ambient temperature selected ranges from 20 – 25°C. Selection of the accelerated aging temperature involves a little more choice. Temperatures of 50°C, 55°C and 60°C are most common but occasionally engineers choose a higher accelerated aging temperature.

One way to explain the use of the Arrhenius equation and Accelerated Aging Factor (AAF) Determination to someone outside of the profession is to describe it as a time machine. The use of these equations allows the engineer to essentially make time go faster in order to prove out their packaging that much sooner.

Where things can go wrong is when the time machine is abused. Choosing an accelerated aging temperature significantly above the common temperatures of 50°C, 55°C and 60°C in order to obtain test results even quicker can have disastrous results.

Forgetting that the accelerated aging theory is meant for homogeneous materials while most medical devices are comprised of multiple materials can lead to trouble. Understanding the Vicat Softening point for each of the plastic materials in a device is key to picking the proper temperature for aging. Once all of the materials have been identified, identify the material that has lowest softening point. Once this is known, a safe and effective temperature can be utilized for the accelerated aging process.

DDL’s Scott Levy relates a story when he first began his testing career: “I was working with a client that wanted 70°C for his accelerated aging. He was aging some product in a PETG tray. I put the samples into the chamber on a Friday and checked them on the following Monday. To my surprise, some of the materials had melted and others had deformed horribly. Let’s just say that’s when I learned my lesson with accelerated aging. Many years later, I still remember that lesson and always work with customers to ensure they pick the proper temperatures for their accelerated aging projects.”

Bottom line: Research your device’s materials so you don’t abuse the time machine.

Have questions about an Accelerated Aging Project? Please contact us today, or call us at 1-800-229-4235.

ASTM D4169-14 Revisions to ASTM D4169 and Impact on Medical Device Package Testing

ASTM D4169 Medical Device TestingASTM D4169-09 recently has been revised to ASTM D4169-14. ASTM D169 is the test method performed by subjecting shipping units to a test plan consisting of a sequence of hazard elements which would be encountered in various distribution environments.

ASTM D4169 is the standard that has been used extensively in the medical device industry, as it is an FDA recognized consensus standard. The Distribution Cycle (DC) most commonly used for medical device packages is DC-13 which is designed for the small parcel and overnight shipping mode. Customized distribution cycles can be designed when the anticipated distribution of the product is well understood and defined.

The changes made to ASTM D4169-14 are as follows:

  • Schedule G – Rail switching
    1. Four impacts instead of three shall now be performed
    2. Assurance Level I shall be used for open-top rail car load tests. Assurance Level II shall be used for boxcar load tests for non-hazardous materials and for TOFC/COFC load tests for non-hazardous materials. There is no Assurance Level III for this Test Schedule now.
    3. If known, container impact surfaces should be the same as occur in actual shipment. If the shipping orientation is not known, or if more than one orientation is possible, the first three impacts should be on that test specimen surface which is deemed to be most sensitive to damage. For the fourth impact, rotate the specimen 180° on the carriage.
  • Schedule H – Environmental hazard
    1. Slight changes were made to the water temperature during spray sessions of ambient conditioning during Assurance Level I.
  • Eight additional references were added.

What does this mean for medical device manufacturers? While there were several changes made to the ASTM D4169 standard, none of them will impact DC 13 testing.

Please contact us if you have any questions about these changes to ASTM D4169, or questions in general about the standard and/or your next package testing project.

Choosing the Right Package Testing Procedure

Many medical device manufacturers (MDMs) struggle with the development of a packaging system design qualification test plan for compliance to ISO 11607. ISO 11607 requires that sterile medical device package systems be capable of withstanding the transportation and distribution environment. This is typically accomplished by performing a package performance test protocol consisting of a series of laboratory tests that simulate the dynamic and environmental hazards associated with the distribution of products to their end use.

Distribution simulation testing is a uniform and repeatable way of evaluating packaging systems by utilizing laboratory equipment to subject the packaging system to specific hazards that may occur within the anticipated distribution environment.  The primary goal is to have an effective shipping configuration that protects the product and package integrity during transit, and ultimately is in compliance with ISO 11607.

One challenge many MDMs have is to determine which procedure to specify for performance testing. There are several distribution simulation test methods that can be used for package performance testing.

The ISO 11607 standard recommends the use of the ASTM and ISTA standards for simulating these hazards in the laboratory. The ASTM D4169 standard has been used extensively in the medical device industry for FDA compliance and has a solid history of releasing high-performing package designs into commerce, as well as identifying potential failures and hazards.  ISTA test methods are also acceptable alternatives to the ASTM methods used by many MDMs for compliance to ISO 11607.

There are a couple of issues to consider when determining which standard to use for compliance purposes. The first is whether the test method is recognized as a consensus standard by FDA. The second is whether the test intensity of the procedures simulating the environment in which the packages will be transported is realistic.

Below are a few tips to consider before making any decisions on your distribution simulation testing.

  1. Work with your testing lab to understand the specific test procedure that you will use to evaluate your shipping configuration for validation.
  2. Perform feasibility testing prior to executing a full blown performance test (shipping/environmental  study).
  3. Work with your package testing lab to ensure you’re using a test procedure that is going to best simulate your distribution environment.
  4. Understand the percent of defects that you are acquiring in shipping your sterile samples to the customer / end user.
  5. Provide adequate time to perform a thorough validation.  

Package Testing in a Just In Time World

As the “Just-in-Time” mentality has become more pervasive within the medical device industry, it has also resulted in many more package validation testing projects being rushed and left to the last minute.

While the “Just-in-Time” mentality is here to stay, it is also important to realize that this “Just-in-Time” mentality can pose a significant risk of compromising the overall validation of your package testing. In some instances, for example, we are seeing MDMs with test projects that just can’t be done in the timeline being requested. Or the quantities of samples they produce are not adequate to meet any type of statistical significance.

With that being said, there are a few things that packaging engineers can do to help improve the testing process.

  1. Give yourself at least a month (ideally two) to plan for your testing validation needs. As this will give you enough time to properly prepare and assure a successful outcome. Taking the time to better understand your test process up front vs. doing everything at the last minute will help reduce costs and help you meet your timeline.
  2. Bring your testing supplier into the conversation as early as possible to head off any potential issues. This will also ensure that you have a successful validation and the level of accurate data needed for submission. As the old saying goes, “failing to plan is planning to fail.”
  3. Communication is still the key. To be successful with package testing, MDMs must figure out a way to better communicate and disseminate the wealth of information and knowledge within their own walls. One of our clients for instance holds weekly conference calls with all its package engineers to share information across the company.
  4. MDMs should also be willing to challenge their vendors and ask why they are recommending a certain test, or how they will verify the data is correct. At the same time, MDMs must also be open to looking at possible alternatives suggested by their vendor to meet their specific needs.
  5. It is also important for MDMs to request and receive adequate reports from their testing lab that are clear and concise and helps paint a picture of the type of testing that was executed.

The ultimate goal for both MDMs and testing labs should be the same: validating the package and/or product to bring safe and effective products to market.

Please don’t hesitate to contact us if you have a question on an upcoming test, or need a quote on a project.

Package Strength vs. Package Integrity

While commonly used methods to test for package strength and package integrity have been around for some time, there still seems to be some confusion in the medical device industry when it comes to the difference between testing the strength of a package versus the integrity of a package. The following blog posts aims to explain the differences between package strength and integrity, and the common tests used to determine each.

Package strength concerns the force required to separate two components of the package. In order to produce acceptable packages on a daily basis and throughout a determined shelf-life validation, it is important to evaluate the strength characteristic. Not only does the strength characteristic play a key role in a shelf-life validation, it lets manufacturers determine on a daily basis that their process for sealing packages is consistent with their predetermined specification set in the process validation. For instance, it could be the force to separate two flexible components of a pouch or a flexible lid and a thermoform tray. These forces may be measured in pounds per inch width, as in the seal/peel test, or in pounds per square inch, as in the burst-test method.

The main culprit for poor package strength is the sealing parameters. If a proper process validation of the sealer is not performed, the medical device manufacturer can expect failure. Some typical package-strength testing include: ASTM D3330, package strength testing by peel adhesion; ASTM F88, package strength testing by seal peel testing; and ASTM F-1140, package strength testing by burst testing.

Alone, these tests of package strength do not necessarily prove the integrity of the entire package. Package integrity testing is important in determining the sterility and the shelf life of a medical device or product. To maintain the sterility of an enclosed product until it reaches its point of end use, the packaging must provide a microbial barrier in the post-sterilization environment. The manufacturer must demonstrate that, under the rigors of distribution, storage, handling, and aging, sterile- package integrity is maintained at least for the claimed shelf life of the medical device. The microbial barrier properties of the package materials and design must be evaluated after exposure to the environmental and dynamic stresses expected for the finished package. Several methods may be used to satisfy these requirements. They involve evaluating the material performance itself and the whole, finished package as produced on the packaging line.

Packages may lose their integrity as a result of the dynamic-related events that occur during processing and distribution. Physical test methods may be used to validate that the package integrity has been maintained throughout the package’s processing, expected shelf life, and handling. Testing includes: ASTM F1929-98, package leak testing by dye penetration; ASTM F2096-02, package leak testing by bubble emission; and ASTM D3079-02 and ASTM D4991-94, package leak testing by vacuum.

Join us at these upcoming events
MEDevice Silicon Valley
Nov. 19-20, 2025
Santa Clara, CA

VIEW EVENTS

We’re here to help. Please contact us to request a quote, or talk to one of our engineers.

CONTACT US

Powered by  GDPR Cookie Compliance
Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.