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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.

DDL Offers Testing Capabilities to Support ISO 10555 Part 6 for Subcutaneous Implanted Ports

DDL is now able to provide testing for subcutaneous implanted ports in accordance with the newly added Part 6 of the ISO 10555 series of test standards. Part 6 standardizes the test methods for subcutaneous implanted ports. DDL’s capabilities include leakage, tensile and needle penetration as covered in Annex A, C, D and E of the standard.

The ISO 10555-6:2015 standard specifies requirements, performance, and user safety issues related to subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition and intended for single use.

This addition to the ISO 10555 series helps catheter manufacturers better understand their products’ performance relative to criteria developed by industry experts. The additional guidance on subcutaneous implanted ports is welcomed as this a newly published part of the standard that fills the gap between FDA guidance and other industry recognized testing methods.

Testing Guidelines for Pre-Filled Syringes

The use of pre-filled glass syringes is becoming more and more prevalent as the preferred delivery device for drugs and vaccines. Pre-filled syringes are a more efficient, reliable and convenient method for drug administration helping to reduce drug waste and dosage errors while also improving safety.

Testing Guidelines for Pre-Filled SyringesA number of testing standards have been developed for the testing of syringes. These standards, however, don’t specifically address pre-filled glass syringes. In April 2013, the FDA released a guidance document on the use of a couple of ISO standards for use in the testing of pre-filled glass syringes in response to some adverse events related to connectivity problems when certain glass syringes are used with connecting devices such as needles, needleless luer connectors, adapters, and transfer units.

The two ISO standards the FDA currently recognizes related to glass syringes and connecting devices are:

  • ISO 11040-4 (Pre-filled Syringes – Part 4: Glass barrels for injectables and ready-to-use pre-fillable syringes)
  • ISO 594-2 (Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment – Part 2: Lock fittings).

The FDA expects all glass syringes intended to deliver drug or biological products have design features to connect to connecting devices in compliance with the ISO 11040-4 standard. The general assumption prior to the adverse events mentioned above was that glass syringes that conform to the ISO 11040-4 standard would ensure connectivity (interoperability) with any connecting devices that conform to the ISO 594-2 standard. However, the glass syringe standard, ISO 11040-4, has certain undefined key dimensions. For example, the standard lacks dimensions for the glass syringe nozzle internal diameter, thickness of nozzle wall, and barrel neck curvature. In contrast, the standard for the connecting devices, ISO 594-2, has specified dimensions in these areas. Therefore, it is possible that a glass syringe that meets the ISO 11040-4 standard may not properly connect to a device that conforms to the ISO 594-2 standard. Thus, the FDA has determined demonstrating conformity with the ISO 11040-4 standard alone does not ensure the glass syringe can be properly connected to connecting devices.

For those who seek to rely on conformity to ISO 11040-4, the FDA recommends taking into consideration the following with regard to the connection to connecting devices:

  1. Syringe inner and outer diameter
  2. Height of the nozzle for a glass barrel syringe intended to connect to a luer lock fitting
  3. Thickness of nozzle wall
  4. Barrel neck curvature
  5. Dimensions to accommodate luer locks with a center pin piercing element.

Data must then be submitted to demonstrate that the glass syringe has connectivity (interoperability) to connecting devices to ensure proper delivery of the drug or biological product.

DDL has assisted a number of customers in testing their pre-filled syringes per the recommendations set out by the FDA in the guidance document. While the guidelines are fairly straightforward, the instructions are vague and implementing the testing requires careful consideration of existing syringe test standards and how they can be leveraged to generate the appropriate data. A copy of the FDA guidelines can be found here.

Please contact DDL with any questions you may have on these guidelines, or if you would be interested in receiving a quote.

Accelerated Aging: Abusing the Time Machine

At the heart of ASTM F1980 “Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices” are the Arrhenius equation and Accelerated Aging Factor (AAF) Determination (Sections 6 and 7). Practical use of the AAF involves choosing an aging factor (Q10) which is typically a value of two (2) for packaging testing, an ambient temperature and an accelerated aging temperature. The typical ambient temperature selected ranges from 20 – 25°C. Selection of the accelerated aging temperature involves a little more choice. Temperatures of 50°C, 55°C and 60°C are most common but occasionally engineers choose a higher accelerated aging temperature.

One way to explain the use of the Arrhenius equation and Accelerated Aging Factor (AAF) Determination to someone outside of the profession is to describe it as a time machine. The use of these equations allows the engineer to essentially make time go faster in order to prove out their packaging that much sooner.

Where things can go wrong is when the time machine is abused. Choosing an accelerated aging temperature significantly above the common temperatures of 50°C, 55°C and 60°C in order to obtain test results even quicker can have disastrous results.

Forgetting that the accelerated aging theory is meant for homogeneous materials while most medical devices are comprised of multiple materials can lead to trouble. Understanding the Vicat Softening point for each of the plastic materials in a device is key to picking the proper temperature for aging. Once all of the materials have been identified, identify the material that has lowest softening point. Once this is known, a safe and effective temperature can be utilized for the accelerated aging process.

DDL’s Scott Levy relates a story when he first began his testing career: “I was working with a client that wanted 70°C for his accelerated aging. He was aging some product in a PETG tray. I put the samples into the chamber on a Friday and checked them on the following Monday. To my surprise, some of the materials had melted and others had deformed horribly. Let’s just say that’s when I learned my lesson with accelerated aging. Many years later, I still remember that lesson and always work with customers to ensure they pick the proper temperatures for their accelerated aging projects.”

Bottom line: Research your device’s materials so you don’t abuse the time machine.

Have questions about an Accelerated Aging Project? Please contact us today, or call us at 1-800-229-4235.

ASTM D4169-14 Revisions to ASTM D4169 and Impact on Medical Device Package Testing

ASTM D4169 Medical Device TestingASTM D4169-09 recently has been revised to ASTM D4169-14. ASTM D169 is the test method performed by subjecting shipping units to a test plan consisting of a sequence of hazard elements which would be encountered in various distribution environments.

ASTM D4169 is the standard that has been used extensively in the medical device industry, as it is an FDA recognized consensus standard. The Distribution Cycle (DC) most commonly used for medical device packages is DC-13 which is designed for the small parcel and overnight shipping mode. Customized distribution cycles can be designed when the anticipated distribution of the product is well understood and defined.

The changes made to ASTM D4169-14 are as follows:

  • Schedule G – Rail switching
    1. Four impacts instead of three shall now be performed
    2. Assurance Level I shall be used for open-top rail car load tests. Assurance Level II shall be used for boxcar load tests for non-hazardous materials and for TOFC/COFC load tests for non-hazardous materials. There is no Assurance Level III for this Test Schedule now.
    3. If known, container impact surfaces should be the same as occur in actual shipment. If the shipping orientation is not known, or if more than one orientation is possible, the first three impacts should be on that test specimen surface which is deemed to be most sensitive to damage. For the fourth impact, rotate the specimen 180° on the carriage.
  • Schedule H – Environmental hazard
    1. Slight changes were made to the water temperature during spray sessions of ambient conditioning during Assurance Level I.
  • Eight additional references were added.

What does this mean for medical device manufacturers? While there were several changes made to the ASTM D4169 standard, none of them will impact DC 13 testing.

Please contact us if you have any questions about these changes to ASTM D4169, or questions in general about the standard and/or your next package testing project.

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