Join us at MDM West to talk to an engineer and get your questions answered.
February 5-7, 2019
Anaheim Convention Center, Anaheim, CA
Join us at MDM West to talk to an engineer and get your questions answered.
February 5-7, 2019
Anaheim Convention Center, Anaheim, CA
DDL is now an official participant in the Amazon Packaging Support and Supplier Network (APASS). The APASS program was designed by Amazon to help support vendors, sellers and manufacturers to obtain certification of their products as Frustration Free Packaging (FFP), Ships-in-Own-Container (SIOC) or Prep-Free Packaging (PFP).
DDL provides package testing to vendors, sellers, or manufacturers in compliance with Amazon’s certification test methods as part of the APASS supplier network.
“Global ecommerce sales continue to rapidly increase as consumers want the convenience of having products delivered to their doorstep. This makes package testing an even more essential part of the equation,” said Corey Hensel, General Manager, DDL, Inc. “DDL is pleased to have worked with Amazon to achieve this certification, and we look forward to helping businesses meet their Amazon package testing requirements,”
DDL is a full-service package testing lab with facilities in MN and CA, both of which provide ISTA certified testing.
For more information on these tests, or to receive a quote, please contact us or call (952) 941-9226 for testing at DDL MN, or call (714) 979-1712 for testing at DDL CA.
To learn more about the program, visit www.aboutamazon.com/sustainability/packaging
In this edition of DDL’s PackReview series, DDL Packaging Engineers Scott Levy and Peter Johnson address some of the frequently asked questions on ASTM D4169, specifically Schedule C vehicle stacking, that they receive from DDL’s customers.
What issues do you see in compression testing?
A Lot. Many of our clients don’t meet the specified calculated load in ASTM D4169- Schedule C Vehicle Stacking.
Will my packages fail if they don’t meet the calculated load?
It depends on who is going to be reviewing your outcome. If somebody in quality or regulatory are reviewing your outcome, they are looking for everything to say “pass.” Technically you can interpret that as a failure. From Scott’s perspective, it isn’t a failure. Transportation simulation is a conditioning test, meaning that you’re executing the testing. But you need to understand afterwards whether you pass or fail based upon product testing, sterile barrier testing, or whatever you are trying to look for after that specific test. For example: in a medical device you want to prove that the sterility maintenance hasn’t been compromised, or you may want to look at the label — but none of that has barring with the transit test in itself.
Scott says that 70 percent of his customers pass compression testing, and the other 30% do not “pass.” “Remember this is a conditioning test, and what you do afterwards is what determines if you pass or fail,” added Scott. You want to take a look at the specific amount of weight that a box is achieving. For example, the compressible load was supposed to be 1200 pounds, and your box met 890 pounds. If your box fails out in the field, then you know that something heavier than 800 pounds was on top of your box. In sterile medical packaging, if they are damaged in any way they will be rejected and sent back. “No one is going to play with a box that has a sterile device in it and take a chance on it.”
What can I do to ensure my package passes compression testing?
If you want to make sure that you get through compression testing, look at two things — your overall cost and your overall risk. Most medical device manufacturers ship their devices all over the world, so what percent of the defect is from crushing and what percent of the defect are having issues that are from those boxes being compressed at a point that their sterile barrier is breached. Once that happens, then yes, you will want to take a closer look. But if this is an occurrence of five or ten boxes out of ten thousand, is that a risk you are willing to take when you know all of these boxes will be sent back? You will need to balance that scenario. What risk are you willing to take, knowing that your box can handle 890 pounds, verses adding a few dollars more to the cost of a box construction to get through a conditioning step?
How do you justify a sample not meeting the compression load?
There are a few ways you can justify a sample not meeting the compression load. Look at how much weight the box did meet, look at the procedure as a conditioning test, and what happens afterwards. If it is sterile barrier, did you pass all of that testing? If that answer is yes, then that configuration is a solid configuration.
If you want to go one step further, look over your overall risk. Never lose sight of your real time data. The ultimate goal of this test is to ensure that the sterile barrier isn’t compromised by shock or vibration.
How do I design a package to test in a stable orientation?
The ASTM D4169 standard mentions testing in the most stable orientation. The most stable orientation would be the wide platform. Although, you could lay this down and stack on top of it, you could potentially run into issues with shipment in compression doing it this way. If you put that box through compression testing and the flutes are not running the correct way, you have absolutely no strength to that box. So when you are designing your package configuration, you need to take that into consideration because that is imperative. For medical devices we are not dealing with 3ft long by 12 inches thick, but if those flutes are not running the right way, you won’t have compression strength with that box.
For any testing you can run into issues, but know that common carriers will put your box in their semis in the most stable orientation, so they don’t keep falling down.
What stack height should I use?
The default stack height is 108 inches. The 108-inch stack height comes from the back of a tractor trailer measuring from the floor to the ceiling. We use the default stack height because the assumption is made that we don’t know how this package is going to be shipped. FedEx or UPS will pick up your package and they will take it in a step truck to either an airport or distribution center. There it will be packed up by another step truck to another airport, or stacked into the back of a semi for transit. From a package testing stand point you don’t know how it’s going to go — that’s why the default is 108-inch stack height.
When customers “fail” compression testing, they end up looking at the standard where there is another number, 54 inches. That 54 inches is meant for LTL shipment. LTL shipment means less than trailer load, meaning nothing is going to get stacked on top of those boxes. For example, if you have a company van and need to send from Minneapolis, Minnesota to Milwaukee, Wisconsin, you then wouldn’t be using the 108 inch high semi. You would use 54 inches to mitigate your compression loads because of your known distribution environment.
If you have any questions, or need further information on compression testing or other testing services, please contact us to speak with one of our packaging engineers.
In the latest edition of our PackReview video series, DDL Inc. Package Engineers Scott Levy and Pete Johnson continue their discussion on ASTM F88 Seal Strength. In this video, Scott and Pete address the one-pound minimum myth, design validation, specification of seal strength and some upcoming changes on the horizon with ISO 11607.
Seal Strength Acceptance Criteria
Currently, most customers use a one-pound minimum seal strength requirement within their protocols. Because of this, DDL often sees customers failing their protocols because they are not meeting this one-pound acceptance criteria. According to Scott, almost every protocol he has seen has had a one-pound minimum seal strength requirement.
Where did this one-pound minimum come from? Based on his research, EN868 has a strength requirement, and going through all of the calculations it gets close to one pound. “However, that one pound does not have much meaning to me,” Scott says. “One-pound or minimum strength requirements should be coming directly from your process validation. Before determining what type of strength that is needed, look at the type of product you have that is going into a particular pouch or tray.”
In design validation, you need to take a look at the strength levels says Scott. “For example, would you put a ten-pound bowling ball inside a pouch with a one-pound minimum strength requirement? Of course not. But, if you put gauze inside a pouch, is one pound an acceptable strength? Absolutely.” Each medical device manufacturer needs to decide on what strength level is acceptable. The key aspect is being able to have repeatability and reproducibility of that strength level you are claiming is your minimal strength. The one-pound minimum has manifested itself as the industry norm, but the one-pound minimum may not be best for your particular application.
Seal Strength Specifications
According to Scott, you should have acceptance criteria to fully understand where you are at with your seal strength testing. Again, the key is consistency in reproducibility and repeatability. In package validation, you want to ensure you have high confidence the strength levels you have been producing after aging and distribution are either equal or better than what you are stating is your strength requirement. Many are doing their strength testing only pre-sterilization. In Scott’s opinion, you should be taking a look at your seal strength levels both pre-sterilization and post-sterilization, as well as after transportation distribution testing, to better understand if sterilization is going to cause any adverse effects.
ISO 11607 Updates on Usability
A big change medical device manufacturers are going to have to deal soon will be the new ISO 11607 revision on usability. During the design validation you are going to have to go out and speak with the end user (scrub nurse, OR nurse, home user etc.) to understand the overall usability of a package. At that, point understanding the strength levels for a specific nurse to open that package is going to be important information.
Package engineers have had to deal with usability of products for years. Now with ISO 11607 being updated, packaging engineers are going to also have to deal with usability of package materials as well (ease of opening, ease of aseptic transfer etc.), and this will be new to many people.
For more information on F88 Seal Strength testing, please contact us or call us at 800-229-4235.
DDL is now offering select medical device testing at its DDL West laboratory located in Irvine, CA. Testing of catheters, Luers, needles, syringes, guidewires and IV infusion sets is now available at this location. Previously, testing of these products was only available at DDL’s headquarters in Eden Prairie, MN.
The DDL West laboratory recently relocated from Fountain Valley, CA to Irvine, CA. The new facility more than doubles the lab space, which will increase DDL’s testing capacity and ability to grow to better meet its customers’ testing needs. The medical device testing being added is in addition to the package testing (ISO 11607) and ICH stability testing already being offered in this lab facility. Full product, materials and package testing capabilities continue to be offered at DDL’s headquarters.
“The addition of medical device testing to DDL West reflects our commitment to offering our customers the best testing experience possible,” said Corey Hensel, General Manager, DDL. “Having these additional testing services will allow us to provide faster turnaround and reduce development lead time and shorten product time-to-market for our medical device and pharmaceutical customers located in California and the surrounding region.”
The testing being added to DDL’s CA lab will utilize the following standards:
For more information on these tests, or to receive a quote, please contact us or call 800-229-4235.
By: Alison Payton, Sales Support Specialist, DDL
DDL once again was a sponsor and attendee of the annual HealthPack conference. This year’s conference was held in Kansas City, MO. In addition to enjoying all the great BBQ, we heard from several leaders in the industry regarding Smart Packaging & Industry 4.0, upcoming changes to ISO 11607, insights from the FDA, and of course, the ever popular Nurses Panel.
Following is a recap of the highlights, industry changes and topics discussed at HealthPack 2018:
Other sessions at HealthPack included:
In summary, HealthPack 2018 was engaging and enlightening and a great way to network with many people in the healthcare packaging industry.
HealthPack 2019 will be held at the Hilton Portland Downtown Portland, OR. March 5-7, 2019. For more information on HealthPack, please visit https://www.healthpack.net.
Join us at MDM West!
Talk to an engineer and get your questions answered. We’ll be at booth #2246.
We’re here to help. Visit us, join in on a webinar or talk to one of our engineers.
You can adjust all of your cookie settings by navigating the tabs on the left hand side.
Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.
If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.
This website uses Google Analytics to collect anonymous information such as the number of visitors to the site, and the most popular pages.
Keeping this cookie enabled helps us to improve our website.
Please enable Strictly Necessary Cookies first so that we can save your preferences!