Packaging Validation Archives – Page 2 of 4

DDL Expands Scope of its ISO/IEC 17025 Accreditation

DDL has expanded the scope of its ISO/IEC 17025:2005 accreditation from the American Association for Laboratory Accreditation (A2LA) to include ISO 80369 testing for small-bore connectors, the ISTA test series for distribution simulation, and numerous standards for environmental conditioning.

The ISO 80369 series of small-bore connector standards are a replacement for the ISO 594-1 and ISO 594-2 standards, though the FDA will still accept submissions citing ISO 594 through the end of 2019. DDL’s ISO/IEC 17025 accreditation will continue to include the ISO 594 standards.

The ISTA series of distribution tests simulate the shocks and stresses normally encountered during handling and transportation. The following ISTA tests have been added to DDL’s scope of accreditation: ISTA 1A, ISTA 1B, ISTA 1C, ISTA 1D, ISTA 1E, ISTA 1G, ISTA 1H, ISTA 2A, ISTA 2B, ISTA 2C, ISTA 3A, ISTA 3B, ISTA 3E, ISTA 3F, ISTA 3H, ISTA 4AB, 6-Sam’s Club, 6-Amazon.com-B, ISTA 6-FEDEX-A, and ISTA-FEDEX-B.

Environmental conditioning is the practice of reproducing the various temperature and humidity extremes that a package or product is expected to be exposed to in its transportation, storage and/or in-use life. The following standards for environmental conditioning are included in DDL’s updated accreditation: ASTM D4332, ASTM F2825, ASTM F1980, ASTM D618, Tappi T402, ISO 2233, IEC 60601, ISTA 7D, and ISTA 2A.

“This expansion of our ISO 17025 accreditation demonstrates our commitment to continually improve our Quality System in order to provide our customers with superior service,” says Corey Hensel, General Manager, DDL, Inc. “This accreditation also demonstrates our technical competency and capability to consistently produce precise and accurate test data our customers can trust in order to meet their regulatory requirements.”

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.

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

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:

Profile spectral shape
Profile intensity (Grms)
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.

DDL PackReview: ASTM-F1929 Dye Penetration

In this edition of DDL’s PackReview series, DDL Packaging Engineers Scott Levy and Peter Johnson discuss the following topics on ASTM –F1929 Dye Penetration testing:

What is Dye Penetration?
Why use it?
What are the different methods?
What are the major concerns?
Can anybody do ASTM-F1929?

Dye Penetration is a physical seal integrity test. The test is meant for seals constructed of one clear material side and the other side consisting of wicking material such as Tyvek material or paper. The dye penetration test is a great seal integrity test with a high degree of sensitivity. This test is primarily used in sealer process qualifications.

Why use Dye Penetration? Dye Penetration is a quick and efficient way to make sure that you have a quality seal. This is a perfect test for sealer process qualifications.

There are three different Dye Penetration methodologies.

Method A: with this method you inject the dye solution within the package and observe the seal for any channel or leaks.
Method B: is the Edge Dip method. This is where you will take the package and physically dip the edge into the dye solution then watch for any wicking upward for any channels. The key to this method is to make sure the edge of your seal is at the edge of the package. If there is any excess material you need to remove that material before you proceed with the Method B edge dip.
Method C is the Eye Dropper method. This method can be used on packages with excess material which extends beyond the seal. Per this method you want to separate the two materials and put a bead of the dye solution along the outside edge and look for channels.

Method A is the one that is most commonly used of these three procedures. The other methods can be considered based on the scope of the project.

One of the potential pitfalls when using the dye solution is you can get false positives. The procedure specifies you should only leave the dye solution in for twenty seconds, which would be five seconds on each side. If over exposed the dye solution can bleed through the wicking material, which can cause a false positive. Another potential false positive can occur when there is de-lamination, as the dye solution often finds the separation between the two materials, which can appear as a failure in some instances.

In order to do ASTM-F1929 Dye Penetration testing there are two things that need to happen. First you need to have your test method validated, and second you need to make sure that you use the formula as specified in the standard. When using Dye Penetration you will need to make sure you can identify the channels and insure there is no variability between your procedure and who is doing the test.

Thank you for watching DDL Inc PackReview series on ASTM- F1929 Dye Penetration. If you have any questions please contact us to speak with one of our packaging engineers.

ASTM F88 Package Seal Strength Testing Overview

Welcome to DDLs PackReview series on Seal Strength Testing

In this video, DDL Package Engineers Scott Levy and Pete Johnson sat down to talk about the most frequently asked questions they receive on ASTM F88 Seal Strength testing. Some of the questions covered include:

What is seal strength testing?
Why use it?
What are the different techniques?
What equipment is used?
Can anybody do ASTM F88 Seal Strength Testing?
What are the major issues DDL sees with its customers?

“Seal strength testing is a uniform way to understand the strength of two materials, along with being able to understand what strength it takes to open that package,” says Scott.

Many have asked, why use ASTM F88 Seal Strength? Scott said, “It is important for the manufacturer to know what type of strengths they are putting on a particular package. You want to have a sturdy seal that isn’t too difficult to peel apart and want to have enough strength on a package so it does not cause for a stability breach, which means they are not forming a seal.”

There are three different seal strength techniques to choose from: Technique A which is held up without support; Technique B, which is holding it between your fingers as a supporting function; and, Technique C which is supported by a backing plate. Technique A and Technique C are the two most commonly used.

ASTM F88 Package Seal Strength Testing Overview When choosing a technique the key word is consistency. When you are looking to do ASTM F88 Seal Strength testing, choose a technique and stay with it throughout the project so you can get consistent results. If you do decide to change techniques in the middle of a project your data will change as well.

While anybody can do an ASTM F88 Seal Strength test with a tinsel tester, the key thing is making sure it is properly calibrated to the proper load cell and you have performed a test method validation.

Lastly, one of the biggest issues that come up is when manufacturers set a minimum of one pound specification and they don’t know where that one pound specification came from. Minimum specifications from seal strength derive from process validation. Setting up a validation you need to understand your low, nominal and high. How much strength does it take to pull this product apart?

The second issue is choosing from Technique A verses Technique C. Technique A will give you a result and Technique C will give you almost two times that result. “If someone is used to seeing high values and they end up using Technique A and see lower values, well there’s a problem,” Scott explained. The consistency aspect of speed rate, technique you run and understanding what your minimum specification is going to be is going to help you get the correct data from the ASTM F88 Seal Strength Testing and what you are looking for.

Please contact us if you have further questions about ASTM F88 Seal Strength testing, or would to speak to one of our package engineers about an upcoming test.

10 Things You Should Do Before Your Next Package Validation

Before you set out to validate a medical device package design or process, you’ve got to do your homework in order to understand what is critical to build the proper foundation for a sterile barrier system and to avoid a breach of that system. Scott Levy, senior packaging engineer for DDL, offers the following 10 points to consider before beginning any packaging validation effort.

Understand the regulatory requirements (FDA, EU, etc.). In general, regulators expect you to prove that your packaging system ensures sterility maintenance of that device and to confirm the consistency of your processes.

Read and familiarize yourself with ISO 11607 so you understand your validation responsibilities. To obtain a CE mark for marketing your medical device in the EU, you must be in compliance with ISO 11607. The good news is that ISO 11607 is also recognized by the U.S. FDA as a consensus standard, so if you are in conformance with it, you will have a much easier time complying with the FDA.

Get your package professionals involved upfront in the product design process. Packaging professionals should be working with colleagues in regulatory, product development, and quality as early as possible during medical device development.

Perform a risk assessment of the medical device you are packaging. Determine the specified attribute data for your package, identify all potential failure modes that could cause (or result from) an out-of-specification package, and then determine the sample size needed to catch those failures.

Talk to your suppliers and service providers. Your vendors have a lot of knowledge about materials and processes, especially when it comes to materials for packages such as pouches and trays. Get as much data as possible from material providers, thermoformers, and package converters, and don’t forget to work closely with machinery providers, who in addition to providing process validation support might also consult on material performance.

Write your packaging protocol and establish clear acceptance criteria. Make sure your protocol includes the following: a purpose, a scope, a reference section listing all standards and test procedures, descriptions of all materials and equipment, all attribute data, a sequence of events or a flow chart of what will transpire, and a summary of the chosen sample size and acceptance criteria. It is important to document everything.

Know your worst cases. Review your product families to define all worst-case scenarios for what potentially can cause the most adverse effects to the package. When identifying a worst case, look for the heaviest, the lightest, the largest, and the smallest. It is a hard question to answer, but you are looking for what potentially can cause the most adverse effects to the package.

Understand the differences between package seal strength and whole package integrity as well as stability testing and package performance. Many people start using test methods before they understand the standards. Before you start any test you need to understand what you are testing, look for test methods that have been validated, and then validate that you can perform them according to the standardized methods.

Do a gap analysis of the test standards that you have previously utilized to what is current. Do a gap analysis when any new standards are released or if there is a change in packaging materials or processes.

Make sound technical science-based justifications if needed. If making a justification, you need to take a look at all factors for a particular justification and make it science based and defendable.

By doing their homework with materials and processes and by understanding what they need to do before validation, medical device packaging professionals will build a successful validation program.

For more details, please download a copy of DDL’s SmartGuide.