Package and Product Integrity Blog

DDL, Inc. will be exhibiting at the 2011 MD&M Minneapolis Expo & Conference next month in the Twin Cities. The show kicks off with the conference on November 1st at the Minneapolis Convention Center.

MD&M Minneapolis’ Expo hall maximizes your time by gathering the world’s best and most qualified suppliers under one roof. They know your industry, understand your objectives, and are ready to help you bring that new device to market and accelerate your project’s completion

DDL’s Lead Packaging Engineer Scott Levy is a co-chair of the Medical Device Packaging Update at the conference on Thursday, November 3rd. We invite you to join Scott, along with co-chair Kevin Zacharias of Oliver-Tolas Healthcare Packaging for an update on happenings in the medical device packaging industry.

DDL will be exhibiting at booth #830 during the expo, where you will have an opportunity to talk to Scott Levy about any current and upcoming package testing projects.

We look forward to seeing you at this year’s show. If you have any questions regarding your package testing needs, please contact us, we are happy to help answer your questions.

DDL Product & Materials Testing Division Project Manager, Jason Stromberger discusses ASTM D882. ASTM D882 is a test method listed in ISO 11607 (Annex B) that is used to demonstrate compliance for packaging materials and preformed sterile barrier systems. ASTM D882 is the standard test method to determine the tensile properties of thin plastic films.

Performing a tensile test can help predict how the packaging will respond to different age intervals or sterilization methods that may have adverse effects on the packaging material.

When working with a third-party testing laboratory it is extremely important to establish a positive working relationship with the laboratory from the start of a project,  through completion of the project. Whether you require testing of packaging, products or materials; knowing how the testing lab would like to work with you upfront makes all the difference in the world.

Here are 12 things your test lab wants to tell you that should help your testing go as smoothly as possible.

1. Be sure to know your test standard.

2. Organize your samples and always document what you send.

3. Provide test set ups so if the lab has to do any exploratory work, it can destroy specimens without consequence.

4. Don’t assume that the lab knows your product as well as you do.  Be sure to tell the lab anything special that it needs to know.

5. Having one point of contact at our lab and your company makes communications easier.

6. Beware of scope creep.

7. Read and understand your quote for testing services.  It’s never fun for either party to realize that something has been left out and might jeopardize a customer’s project.

8. If you have multiple tests but not enough specimens for each test, make sure to address the order of testing (ex: non-destructive testing first, then destructive testing; easy tests to more robust tests).

9. If your product fails a test, we can only comment on the testing that we did.

10. Special requests are no problem, but be sure to communicate them up front.

11. Know what you want the testing to accomplish, if you are not specific, you may not get what you want.

12. If you prepare your own specimens, make sure they are to the standard.

Most testing laboratories have guidelines that they would like customers to follow, however, they aren’t always addressed up front. Taking into consideration these 12 steps will help all parties involved in testing projects, to support open communications and help to maintain a great business relationship.

ASTM has recently issued a new standard which tests the mechanical seal strength for round cups and bowl containers with flexible peel-able lids.  This test provides measured values for average seal strength, work and maximum seal strength when using a universal tester to separate the entire lid (cover/membrane) from a rigid or semi-rigid round container.

While the standard is specifically for round containers; oval, rectangular and circular containers with single or multiple cavities can be tested.  The test applies to various industries including food, chemical and pharmaceutical.   This test allows manufacturers of these containers to compare adhesives, seal methods and the affects of post sealing treatments such as aging or sterilization.

ASTM F2824 cites ASTM F88 which many of our customers are familiar with.  F88 tests a portion of a seal and provides an actual seal strength picture of the portion of the seal under test.  F2824 tests the entire seal by pulling the lid off at a rate of twelve (12) inches per minute while maintaining a peel angle of 45 degrees throughout the pull.

The 45 degree angle requires the test specimen to move during the test and in some cases requires a custom fixture to hold the container.  DDL is equipped to carry out this test and has several methods to create custom test fixtures for the best test results possible.

“A good example that helps people envision this test is peeling the foil lid off of a yogurt container” says Al Gale, Sales Engineer for DDL’s Product & Material Division.  “When you perform that simple act you can feel that the initial portion of the pull is harder than when you are in the middle of your pull and the pull gets harder again at the end.  This is exactly what our universal test sees and records during the test.”

Levi L., one of the product managers in DDL’s Product & Materials Testing division shows us how a guide wire test is conducted based on testing standard ISO 11070 Annex F, which is the fracture test. When tested in accordance with annex F, the guide wire, excluding the region of fixation and the first turn, shall show no signs of fracture, and coated guide wires shall show no flaking of the coating.

There are a variety of ways to test plastic materials, such as the plastic used in medical device packages.  Puncture testing is a common method where a piercing tool, referred to as a tup, is driven completely through a test specimen.  The energy to puncture is calculated based on how far the tup travels and the force needed to pierce the test specimen.  One variation of puncture testing is high speed puncture testing which requires the tup to move at a rate between 2.5 m/min and 250 m/min (1.64 in/sec and 164 in/sec).

At DDL the high speed puncture test set up consists of a hydraulic actuator, tup, circular clamp, load sensing device, a set of controllers, data acquisition board and a PC.  When the test is run the final test results include the peak load experienced by the test specimen, the distance traveled by the tup and the corresponding energy.  A graph is also created displaying force against travel distance.

This repeatable and reliable test gives customers simple yet important energy values for comparing specimens from different production lots, sterilization methods, aging cycles and other variables of interest.  The analysis of the data can go deeper when the force, displacement, time and various rates of change are further examined.  While the actual puncturing event only lasts 10 to 20 milliseconds, the resultant data provides customers with some very important and easily understood information.

ASTM has two high speed puncture tests, ASTM D 3763 and ASTM D 7192.  D 3763 is for rigid plastics and D 7192 is used for plastic films that are 0.010 inches or thinner.  Both of these tests are part of DDL’s Product & Materials Division’s core test list.