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ASTM-F88 Seal Strength – Is the One-Pound Minimum Real or a Myth?

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.”

Design Validation

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.

HealthPack 2018 Recap

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:

  • Ed Dunn, Head of Global Supply Chain, Packaging Center of Excellence at Johnson & Johnson, opened up the conference with a Keynote discussion on “Industry 4.0” and what this means for Packaging and Healthcare. Dan Burgess, Principal Packaging Engineer & Manager at Boston Scientific, enlightened us about Smart Packaging and how these various new technologies, such as RFID technology, add value to our operations and provide more data about the transit and storage environments through tracking and remote sensing.
  • Scott Levy, Packaging Engineer at DDL, participated in HealthPack’s Preconference Roundtable regarding the new clause in upcoming revisions to ISO 11607-1. Michael Scholla, Global Director, Regulatory Standards at DuPont and Thierry Wagner, Regulatory Affairs Director EMEA at DuPont Medical and Pharmaceutical Protection, discussed these vital revisions in detail during their presentation at the main conference session. Here are the key points from their presentation:
    • New language will be added that encompasses the concepts of sterile package ‘maintaining sterility up to the point of use’, design allows for ‘easy and safe handling’ and the package ‘integrity bring evident’ to the final user.
    • In addition, the revisions include requirements on demonstrating the usability and aseptic presentation of the sterile package.
    • New requirements will need to be supplied on the package that indicate the Sterile Barrier System, the month and year of manufacture, and instructions on what to do if the sterile packaging is damaged or unintentionally opened before use. The Sterile Barrier Association is working on proposed symbols to fulfill this requirement.
    • Lastly, a new section with requirements for validation and changes will be added that describes that packaging systems that meet the requirements of design, usability, performance testing and stability testing shall be considered validation and revalidation will occur if there are changes to the design, contents, materials or shipping configurations.
  • Scott also participated in the “Systemic Approach to Seal Strength” Panel Discussion alongside Rod Patch, Director, Packaging Center of Excellence, Medical Devices at Johnson & Johnson, Goeff Pavey, Technology Manager at Oliver Healthcare Packaging, Thomas McNabb, Principal Project Engineer at Medtronic Neurovascular, and Nick Layman, Staff Franchise Packaging Development Engineer at Ethicon. The panel discussion engaged the audience by addressing several industry concerns regarding minimum seal strength (Note: there is no industry standard for minimum seal strength!) and defining your seal strength values based on the characteristics of your device and shipping configurations. Nick Layman of Ethicon pointed out, “Seal strength is product specific! It has to relate to your product and its weight. Consider how your customer is going to be handing it.” Scott discussed that highs and lows for seal strength values need to be scientifically justified and rationalized as to why they were picked, which will ultimately be dependent on your equipment and package design

Other sessions at HealthPack included:

  • The FDA perspective: Voluntary Recalls and Deficiencies for Package Processes presented by Patrick Weixel, Acting Deputy Office Director of Patient Safety and Product Quality at the FDA
  • Six Steps to Successful Remediation, presented by David DiVaccaro, Principal at DiVaccaro Consulting Group
  • Live Audience Interactive Polling Session
  • Sample Size Strategic Planning and Optimization, presented by Jennifer Van Mullekom, Associate Professor of Statistical Practice and Director of Laboratory for Interdisciplinary Statistical Analysis at Virginia Tech
  • Material Selection in Flexible Packaging, presented by Dhuanne Dodrill, President at Rollprint Packaging Products
  • Let’s Make SBS Seal Strength Testing Really Easy! presented by Sameer Upadhyaya, Head of Technology at Genentech

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.

DDL Relocates its California Laboratory

DDL announced it has relocated its California lab from Fountain Valley to a facility located in Irvine. The new facility more than doubles the lab space, which will increase DDL’s package testing capacity and ability to grow to better meet its customer’s testing needs.

“Our new California facility in Irvine reflects both our continued business growth and our commitment to offering our customers the best packaging and distribution testing experience possible,” said Corey Hensel, General Manager, DDL. “This additional capacity also allows us to provide faster turnaround for our medical device and pharmaceutical customers, which helps reduce development lead time and shorten product time-to-market for all of our customers.”

The new DDL laboratory is located at 9400 Toledo Way, Irvine, CA 92618.

Watch a video tour of the new DDL West laboratory.

Please contact us for more information about our new California testing location, or to receive a quote.

Highlights from HealthPack and ISTA TransPack Forum

DDL recently participated in the annual HealthPack Conference and ISTA TransPack Forum. Following is a recap of the highlights and issues that were discussed during this year’s conferences.

Beginning our adventure in Denver, CO, the turnout at HealthPack 2017 was even greater than in the past, with over 300 attendees. Some of the highlights from this year’s HealthPack include:

  • Jan Gates, Principal Packaging Engineer at PackWise Consulting, went over some of the upcoming changes happening with standards in her session on “Standards Updates.” The key updates include ASTM D4149, ISO TC 122, WG14, WG05 and WG09. ASTM D4169 is being revised for current practices and data. The truck vibration was recently updated in order to show various vibration profiles and comparison to original vibration profile. The next change being looked into for ASTM D4169 is for plane vibration, as the preliminary data shows the air vibration is not as current in the standard.
  • Laura Bix, Professor and Associate Director, School of Packaging of Michigan State University, discussed, “Objective Evaluation of Label Design”. For those who are on the outside of the industry looking in they would never realize how much goes into the thought process of labels and packaging. While listening to Bix’s session about the challenges with critical information that must be quickly identified and readable in the field for nurses as well as the end user was very interesting. For example, a few of the many that she went through is the need for transparent packaging to allow quick identification of contents, diagrams, color coding systems that would need to be consistent and universal, to have the important information together and highlight the critical information. There was also discussion on the expiration date, latex free and sterility (secondary packaging present).
  • One of the most popular sessions at HealthPack is the Nurses Panel. This is a great opportunity to ask the nurses and technicians what is important to them in packaging and labeling. It was great to hear what they are looking for in packaging in their field. Many things were brought up but some of the main characteristics were:
  • Display a clear Lot#/ Reference # and date of expiration.
  • Shape of packaging, easy for any size person to open.
  • Making sure that the sterility of a product stays sterile through the opening process to the end user.

Other sessions at HealthPack included:

  • Split Personalities: Development and Compliance
  • Guiding Material Selection through Function and Value
  • Sterility Assurance: An End to End Supply Chain Approach
  • The Next Generation of ISO11607\Objective Evaluation of Label Design for Healthcare Products
  • Applying Human Factors to Optimize the Usability of Packaging

Following the HealthPack tradeshow DDL headed to the ISTA TransPack Forum in sunny Orlando, Florida. DDL’s Packaging Project Managers Matt Doornink and Jacob Heffernan attended this year’s sessions, workshops and the volleyball tournament. Here’s a recap of the highlights and what they learned:

  • ISTA TransPack Forum is a good opportunity to better learn how DDL’s customers are attempting to further their understanding of the distribution environment, as the packaging profession is continually challenged by the continually evolving distribution environment.
  • A few presentations addressed the changing distribution environment, such as how retail has moved to e-commerce and is now beginning to test drone deliveries. A presentation by Clemson University demonstrated some of the patents Amazon has on the future of shipping including underground tunnels and floating distribution centers where drones would collect products and then deliver them.
  • Another presentation that stood out was Bernard McGarvey’s and Bryan Cardis’s from Eli Lilly and Company discussion on the performance and creating of profiles for thermal shipping containers. In their presentation, McGarvey and Cardis showed the relationships between the pre- usage temperature exposure and the duration to the final performance of the container to its destination, creating a performance curve to find the optimal usage for time and temperature.
  • In addition to the many great sessions and workshops there was also the annual volleyball tournament, which DDL has sponsored for the past several years. The volleyball tournament is always a great way to get to know industry peers and network with other companies. “This year we participated in the fun games, although we were not successful going 0-2, but each game went down to the wire. I am confident we are one year away from being one of the top teams in the tournament” said Doornink.

In addition to many informative sessions, a great part about attending conferences such as HealthPack and ISTA TransPack Forum is it provides an opportunity for members of the medical device packaging industry to reconnect with old colleagues, as well as interact with customers and meet new contacts.DDL looks forward to participating in next year’s HealthPack being held March 6-8, 2018 in Kansas City, MO, and the ISTA Transpack Forum being held March 20-23, 2018 in San Diego, CA.

What are differences between ASTM D4169-14 and ASTM D4169-16?

Welcome to the latest edition of DDL’s PackReview video series. In this edition, DDL Packaging Engineers Scott Levy and Peter Johnson discuss the recent updates to ASTM -D4169 and address the following questions.

  • What are differences between ASTM D4169-14 and ASTM D4169-16?
  • Why they made the change?
  • Why the change is important?
  • What are the questions we have been receiving from clients?

The ASTM D4169 standard has recently been updated, which is causing some controversy within the industry and raising questions about what version to use: ASTM D4169-14 or D4169-16.

The difference between ASTM D4169-14 and ASTM D4169-16 is how the truck vibration testing is performed. ASTM D4169-14 utilizes static assurance levels for the truck vibration profile. An assurance level is the overall intensity level that you are going to subject your packages to while undergoing vibration. ASTM D4169-16 incorporates the various test intensities (low, medium, high) and durations into one truck vibration profile.

The reason for the change is that outdated data was being used. What does that mean? It means that if you have used these procedures in the past you may have been over testing your package. This is important because, if you are only doing distribution simulation once, you are testing at an extremely high threshold and seeing consistent failures that you are not seeing in the real world.

The revision to ASTM D4169-16 was done to give a clearer and concise laboratory profile to better mimic what is truly happening in the industry and also to your packages. They have adjusted your vibrations in the new update. The assurance levels are still intact with ASTM D4169-16 excluding Schedule E vibration testing. Changes to Schedule E were with the truck vibration profile. The recent data collected in the field shown in the previous vibration profiles in the truck spectrum were no longer accurate. The changes have been made to the truck spectrum, the actual profile spectrum, test intensities and test duration.

Many of our customers are asking if they can still use version ASTM D4169- 14 instead of ASTM D4169-16. Using ASTM D4169-14 is still acceptable if you feel more comfortable using vibration testing at the high intensity level. However, you must take note the intensity levels with ASTM D4169-14 are more severe than what your samples will see on a regular basis and this may increase the chance of a causing a failure with your testing.

For more detail on the information, please watch the video above to help answer any questions you may have.

Thank you for watching DDL Inc PackReview series on the updates to ASTM-D4169. If you have any questions please contact us to speak with one of our packaging engineers.

ASTM D4169 Truck Profile Update

ASTM D4169, the standard practice for performance testing of shipping containers and systems, has recently been updated. The truck vibration data, profiles and testing techniques are the basis for the updates. Following is a summary of the rational for the update.

Rational for Update

In recent years the truck profile data referenced in ASTM D4169 Section 12.4 has not been representative of the data collected from recent truck measurement studies. As a result of this, the following updates have been made to reflect the more current field data that had been measured.

Three primary characteristics to any random vibration profile are as follows:

  1. Profile spectral shape
  2. Profile intensity (Grms)
  3. Profile duration (time)

1. Profile Spectral Shape:
Based upon a number of recent truck measurements throughout the Americas, the spectral shapes measured match current and widely used industry test specifications. This provides justification to cross‐reference other widely accepted Steel Spring Truck profile as the basis for the proposed ASTM D4169 truck profile spectral shape.

2. Profile Intensity:
The current measured truck data comprehensive statistical data summaries show:

  • 90% of the measured data is at or below an intensity of 0.40 Grms
  • 95% of the measured data is at or below an intensity of 0.50 Grms
  • 99% of the measured data is at or below an intensity of 0.73 Grms

The update recommends conducting the test using a consistent shaped profile at varying test intensities. The following paragraphs explain the proposed levels of intensity.

Low Level ‐
The measured data indicates that 90% truck vibration occurs at a lower intensity level of up to 0.40 Grms. The update to the D4169 Truck Profile recommends testing using the proposed spectral shape starting at an intensity level that is comparable to the 90th percentile of the referenced measured data.

Medium Level ‐
The current ASTM D4169 Truck Assurance Level II profile shape is not representative of the truck environment but its intensity level—0.52 Grms—is comparable to the 95th percentile intensity level of 0.50 Grms. The update recommends testing using the ISTA Steel Spring Truck Profile at the 0.54 Grms intensity level which is slightly higher than the 0.50 Grms level and can be considered a worst case medium intensity level vibration.

High Level ‐
The measured data also contains some vibration which occurs at a higher intensity (0.73 Grms). To simulate these more intense vibration events, the update recommends testing using the proposed spectral shape with an intensity level that is comparable to the 99th percentile of the referenced measured data.

3. Profile Duration:
Currently, when performing an ASTM D4169 simulation for Distribution Cycles 1, 3, 4, 5, and 6, the truck vibration test is performed at a single intensity level (e.g. Assurance Level II) for the entire test duration. The update recommends the use of three different intensities—Low, Medium, and High—that correspond with the 90th, 95th, and 99th percentile intensities as discussed above.

The same measured vibration data used to determine the Low, Medium, and High intensity levels can also be analyzed to determine the relative amount of time that those intensity levels occur. By definition, 90th percentile (Low) intensity vibration occurs more often than the 95th percentile (Medium) intensity which occurs more often than the 99th percentile (High) intensity.

Many test labs have a historical precedent for using three‐hour test durations for ASTM D4169 vehicle vibration tests. The three‐hour test duration allows enough time for test items to respond to the test intensity and maintain an efficient time window from a test laboratory productivity perspective. To maintain that overall test duration of three hours (180 minutes), it is recommended that the truck profile spectral shapes are used at the following test intensities (levels) for a total amount of time as follows:

  • Low Level: 120 minutes
  • Medium Level: 45 minutes
  • High Level: 15 minutes

Distribution Cycles 9, 10, 12, and 13 require simulating more than one type of vehicle vibration and only recommend a 60 minute Truck test. In other cases it may be necessary to rotate the test item so it experiences the vibration is different orientations. To accommodate all the different manners in which the Truck vibration will be utilized, the Low, Medium, and High test profiles should be performed in 60 minute loops as detailed below. For a 60 minute Truck test, only one loop would be performed. For a 180 minute Truck test, three loops would be performed.

Note:  It is important to note that there have been no modifications to the air and rail profiles and they will continue to be executed as they have in the past.

Note:  The rational provided with the ballot was used as a basis for this document.

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