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DDL Celebrates 25th Anniversary

DDL, Inc. is celebrating its 25th anniversary of providing package, product and material testing to the medical device industry.

DDL was founded in 1990 by John Hart and Patrick Nolan. Hart and Nolan had previously worked for Eden Prairie based testing products supplier MTS Systems. The two started DDL (originally called Distribution Dynamic Labs) when an opportunity for a testing lab presented itself.

From 1990 to 2003, DDL operated one testing laboratory at its headquarters in Eden Prairie, MN. In January of 2003, DDL opened a second lab in Costa Mesa, CA. This lab (DDL West) is now located in Fountain Valley, CA. In September of 2007 DDL merged with TCP Reliable, a full service manufacturer for temperature controlled packaging products and phase change materials, located in Edison, NJ. DDL was also one of the first testing labs to receive ISO 9001:2008 certification and recently received ISO/IEC 17025:2005 accreditation.

“We are proud of the vast array of testing services we have been able to provide to the medical device industry over the past 25 years,” says Corey Hensel, General Manager, DDL, Inc. “We consider our success to be a direct result of the loyalty of our clients, the dedication of our employees and the continual improvement of our quality system. We look forward to continuing to work closely with the medical device industry and fulfilling their testing needs.”

DDL Expands Its Medical Device Package Testing Capacity

DDL has expanded capacity for medical device package testing at its laboratories in Fountain Valley, CA and Eden Prairie, MN.

The expansion includes the addition of more chambers at its recently opened facility at the Fountain Valley laboratory to provide increased capacity for environmental conditioning, real time aging and accelerated aging testing. Additional chamber capacity has also been added at the Eden Prairie facilities.

“This expansion gives us even more capacity to conduct package validation preconditioning as required by ISO 11607,” said Corey Hensel, General Manager, DDL. “This additional capacity also allows us to provide faster turnaround for our medical device customers, particularly with large quantities and volumes of package validation. The ability to immediately place validation samples in their conditioning and aging environments helps reduce development lead time and shorten product time-to-market for all of our customers.”

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.  

How to Get the Best Information From Your Sutherland Rub Testing Regimen

When labeling a product, ensuring that you are using the best combination of materials to present the product as intended to the end user and while reducinge costs as much as possible are major considerations. There are a seemingly unlimited number of different types of label materials and inks both with different properties. When it comes to quickly and easily testing the durability of inks and substrates of prospective materials, there’s no better test than ASTM D5264; Standard Practice for Abrasion Resistance of Printed Materials by the Sutherland Rub Tester.

DDL recently added the capability to perform the Sutherland rub test and it became immediately apparent that there is some misunderstanding of what Sutherland rub testing is and the information that it provides. This article will help explain the basic purpose of the test and the type of information one should expect to gain from a well-designed test program.

The Sutherland rub test is designed to provide qualitative, comparative data for the abrasion durability of multiple label constructions. The ASTM standard does not provide any pass/fail criteria for the testing as the test is only for comparing relative performance and not designed to set a particular standard. The test is not designed to replace any other tests (transportation simulation testing, for instance) which may, directly or indirectly, give information about the suitability of a label construction.

In order to effectively test multiple label constructions, there are three test variables that must be adjusted in order to optimize the testing. These variables are:

  • Test weight (2 lb. or 4 lb.)
  • Number of test cycles
  • Test speed – a high test speed is desirable, but the speed must be chosen so that frictional heating doesn’t influence test results.

The goal is to choose the test variables such that when the test is complete, there is a clear difference in the degree of degradation of each label type. For instance, if the test setup is too rigorous, all labels will be degraded to the point that there will be no way to determine which performed the best. On the opposite side, if the test is not stringent enough, even the weakest construction may not show any degradation. Typically, an exploratory test is required to be performed for each different label construction to best determine the optimum test variable settings to use for testing all label constructions.

When qualifying several possible label constructions, it is important to understand the objective of Sutherland rub testing and the information it can provide. A well-designed experiment can help you determine the ink and substrate combination that gives you the most durable and cost-effective solution for your particular application.

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.

DDL Offers Tip #5 of “Driving Sustainability: Five Tips for the Packaging and Device Testing Industry”

#5 – Empower Employees to Drive Sustainability

Employees are a powerful asset in the effort to improve sustainable practices.  They are the people who see firsthand the daily practices in the lab space.  Training them to think in a sustainability context will bring forth many unforeseen opportunities for improvement that otherwise may have gone unnoticed.  Providing a venue for active dialog between management and staff enables continual improvement of processes and bestows added value unto the workforce.

Providing training on a regular basis (semi-annual) will keep employees thinking about sustainability and encourage consistent implementation of the practices described above.  The best way to see these measures executed effectively is to create a culture of sustainability in the workplace.

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