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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 594-1 and ISO 594-2 testing for conical (Luer) fittings.

A conical Luer fitting is the most common means of achieving a leak-free connection between two medical devices (e.g. a syringe and hypodermic needle) that carry small volumes of fluids. There are two varieties of Luer taper connections known as Luer-lock and Luer-slip. ISO 594-1 defines the dimensions and validation test specifications of Luer-slip fittings. ISO 594-2 defines the dimensions and validation test specifications of Luer-lock fittings. DDL tests both standalone Luer adapters and Luers which are components of various devices, and has large collection of reference connectors which allows for dramatically reduced timelines to complete testing.

ISO/IEC 17025:2005 is the international standard by which a laboratory’s commitment to quality and technical competence are evaluated. DDL previously achieved ISO/IEC 17025:2005 accreditation for its distribution testing, and strength and integrity testing by demonstrating its laboratories are in compliance with the standard and A2LA accreditation requirements.

“This expansion of our ISO 17025 accreditation to include ISO 594-1 and ISO 594-2 testing further demonstrates our commitment to continuously improve our Quality system and offer superior service within our industry,” says Corey Hensel, General Manager, DDL, Inc. “This accreditation also further demonstrates our technical competency and capability to produce precise and accurate test data our customers can rely upon to meet their regulatory requirements.”

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

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 OverviewWhen 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.

  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.

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.”

DDL Receives ISO/IEC 17025 Accreditation

DDL is pleased to announced its Eden Prairie, MN and Fountain Valley, CA facilities have received ISO/IEC 17025:2005 accreditation from the American Association for Laboratory Accreditation (A2LA).

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. This accreditation covers distribution testing, and strength and integrity testing.

“Receiving accreditation for our laboratories demonstrates to our customers that we continue to adhere to the highest level of quality assurance,” said Corey Hensel, General Manager, DDL, Inc. “Combined with our recently renewed ISO 9001:2008 certification, the ISO/IEC 17025:2005 accreditation validates DDL’s commitment to continuously improving our quality program in an effort to offer superior service within our industry.”

“ISO/IEC 17025: 2005 is becoming an essential standard for testing facilities serving the medical device industry,” said Patrick Waddick, Quality Assurance Manager, DDL, Inc. “This accreditation further reaffirms our technical competency and capability to produce precise and accurate test data that our customers can rely upon to meet their regulatory requirements.”

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

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