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DDL Enhances its Medical Device Testing Capabilities with addition of Keyence Image Dimension Measurement Machine

DDL has enhanced its testing capabilities for medical products such as luers, syringes, needles, catheters, guidewires, as well as packaging materials with the addition of a Keyence Image Dimension Measurement Machine.

The new Keyence machine combines an optical comparator, measuring microscope, optical coordinate measuring machine, profile measurement system, caliper and a micrometer into one. This new equipment will provide DDL with the following enhanced testing capabilities: 

  • Measurement of the outside diameter (OD) of catheters, guidewires and syringes with more precision.
  • Measurement of the dimensional requirements of a syringe that complies to ISO 7886-1 in 3 quick steps.
  • Measurement of the plunger depth in a syringe barrel with more accuracy.
  • Measurement of the different dimensions of a needlepoint with one push of a button.
  • Measurement of the holes or channels in a Tyvek/ poly pouch to check for failures.
  • Measurement of the seal width of tensile specimens with more accuracy.

“The addition of the Keyence machine to our laboratory reflects our commitment to offering our customers the best testing experience possible,” said Tamera Presler, General Manager, DDL, Inc. “Having these enhanced testing capabilities will allow us to provide more accurate and efficient testing for our medical device and pharmaceutical customers.”

For more information on these tests, or to receive a quote, please contact us or call us at 800-229-4235.

DDL’s Irvine, CA Lab Adds Pallet Testing and Sutherland Rub Testing

DDL announced it has added additional testing capabilities in its Irvine, CA lab. The new testing capabilities include pallet testing and Sutherland Rub testing.

Pallet Testing
Pallets are important to many industries, as most products are shipped on a pallet at some point in the manufacturing and sales process. If a pallet fails to provide a safe and stable platform, packaged products may be damaged, resulting in added costs. DDL tests pallets to make sure that they can hold and support full unit loads of products throughout the transit process.

Sutherland Rub Testing
Abrasion damage to printed materials can occur during shipment, storage, handling, or by the end user. This abrasion can result in significant degradation in product appearance and legibility of the product information. The legibility of printing on labels or other materials is very important for medical device and pharmaceutical products in particular.

The Sutherland Rub Test helps determine the amount of scuff or abrasion damage that may occur to printed materials during shipment, storage, or handling. This test procedure can simulate the effects of human use in continuous contact or dual surface abrasion in a variety of types.

“The addition of pallet testing and Sutherland Rub testing to our Irvine, CA lab reflects our commitment to offering our customers the best testing experience possible,” said Tamera Presler, General Manager, DDL. “These additional testing services will allow us to provide enhanced package testing services to our medical device and pharmaceutical customers located in California and the surrounding region.”

DDL now offers pallet testing at its CA, MN and NJ lab locations and Sutherland Rub Testing at its CA and MN locations.

Please contact us for more information.

DDL’s MN and CA Testing Laboratories Transition to ISO 17025:2017

DDL is pleased to announce its Minnesota and California testing laboratories have completed the transition to ISO 17025:2017.

“This transition reflects a tremendous amount of work on the part of DDL personnel to demonstrate compliance to the current standard, to embrace best practices, and to continuously improve how we conduct business,” said Christine Velarde, Quality Assurance Manager, DDL, Inc. “This success is due to the collaboration mindset of our employees and determination to function as a team. We are proud to have achieved this significant milestone.”

Accreditation to ISO 17025 requires that a laboratory can demonstrate implementation of a Quality Management System compliant to the requirements within the standard in addition to providing objective evidence of technical capability and competence. DDL’s Minnesota and California testing laboratories have both been ISO 17025 accredited since 2015. DDL’s Edison, New Jersey testing laboratory is in the process of becoming an ISO 17025:2017 accredited laboratory.

To download a copy of the updated certifications, please visit
https://www.ddltesting.com/about-ddl/quality-and-certifications/ or call 800-229-4235 if you would like to speak with one of our testing experts.

Cryopak Testing Center Rebranded as a DDL Testing Laboratory

DDL announced that the Cryopak Testing Center, a 6,000 square foot independent laboratory located at Cryopak’s Headquarters in Edison, NJ, has been rebranded as a DDL testing laboratory.

The newly rebranded DDL lab in Edison offers a full suite of package testing including environmental conditioning, distribution simulation, integrity and strength testing, thermal performance, and shelf life testing. DDL will follow the Cryopak Cold Chain Quality System, which is currently ISO 9001: 2015 certified and ISTA certified, with plans to become ISO 17025 compliant and ISTA certified under DDL’s quality system over the next twelve months.

“The addition of the Edison, NJ laboratory will help to extend DDL’s package testing offerings to better serve the needs of the pharmaceutical, medical device, and consumer goods industries on the East coast,” said Tamera Presler, General Manager, DDL, Inc.

DDL and Cryopak, along with LaunchWorks and NexKemia, are subsidiaries of TCP Reliable.

Please contact us for more information or call 800-229-4235 if you would like to speak with one of our testing experts.

Why Are Test Labs Pursuing ISO 17025 Accreditation And Why Is It Important to Medical Device Manufacturers (MDMs)?

Medical device contract testing laboratories are seeing more requests from MDMs for regulatory support (performing regulatory testing and maintaining appropriate quality systems – namely, ISO 17025).

In an effort to better serve the MDM community many test labs are pursuing ISO 17025 accreditation.  This internationally recognized standard is considered essential for testing facilities around the world and accreditation provides formal recognition of technically competent testing organizations.

The accreditation process is voluntary and assessed periodically by an independent, third-party registrar. As such, a testing company’s laboratory and quality management systems are thoroughly evaluated for compliance with the ISO 17025:2005 standard.  Accredited labs are then in a much better position to demonstrate that they are capable of producing precise and accurate test data, meaning the results can be relied upon.  This can reduce costs for MDMs by reducing the need for redundant audits of its suppliers, who have been through the rigorous scrutiny of its daily laboratory practices and hold that accreditation.  It can also eliminate potential trade barriers.

ISO 17025 accreditation ensures continued technical competence and puts testing labs in a favorable position to provide more development support for medical device companies with regard to testing, where there has been a recent uptick.  Accurate and reliable testing during development phase work is seen as value-added as issues can be identified much farther upstream (when those issues can be corrected easily and cost-effectively).

 

DDL Offers Tip #4 of “Driving Sustainability: Five Tips for the Packaging and Device Testing Industry”

#4 – Conduct Regular Assessments of Current Practices

Information must be collected and analyzed to gain an understanding of current performance in terms of sustainability.  If the company adheres to a standard such as ISO 14001 or has an environmental management system in place, this practice will already be occurring.  But if not, there are several ways to benchmark performance.

 Track the volume of waste generated on a daily basis as efforts to reduce waste are implemented.  Map temperature and humidity data in lab spaces before and after the addition of thermal barriers, insulation, etc. to provide concrete evidence of improvement.   Track energy consumption as changes are implemented to demonstrate the cost saving capabilities of these programs.

Read Tip #5

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