Importance of Vibration Testing Not Realized By Large Percentage of Medical Device Packaging Professionals
MINNEAPOLIS –August 12, 2008 — http://www.testedandproven.com/ — DDL, the leading product and package testing services firm specializing in medical device package testing, recently discovered through the company’s July “Vibration Testing Quizzler” that only 46 percent of Medical Device Packaging Professionals truly understand that vibration testing can prevent defective products or packaging from going to market.
In his winning Vibration Testing Quizzler response, David Anderson VP of Research & Development at GT Urological stated, “When there is the slightest chance that any of our medical products will be exposed to a transportation, operation or storage environment, it is vital that we implement vibration testing before going to market.”
The vibration testing quizzler question below received answers from nearly 200 medical device packaging professionals.
Question: Package and product testing should always be expanded to include vibration testing when there is a chance of exposure to what environments?
Minneapolis, MN, April 12, 2007 – http://www.testedandproven.com – DDL, a leading package, product and material testing services laboratory, has expanded both its Minnesota-based testing facility and its menu of service offerings.
DDL is now able to provide Package Design, Development & Prototyping Services, designed to help manufacturers and package engineers design packaging that will satisfy industry requirements and successfully pass package testing and validation procedures.
“We feel that there is definitely a market for prototyping services,” said John Hart, CEO of DDL Inc. “Packaging often fails testing procedures because it isn’t properly developed in the design and prototyping stages.”
Package Development & Prototyping Services from DDL include:
• Package design & consultation
• Primary, secondary and shipping unit packaging
• Rapid package prototyping
• Small volume production
• Project management
• Regulatory compliance & feasibility testing
• Gap analyses for compliance to ISO 11607
• Environmental conditioning
• Cold chain packaging support
• Altitude testing
“By offering comprehensive package development & prototyping services, DDL hopes to minimize the need for re-testing and help customers deliver their products to market on time,” said Patrick Nolan, COO of DDL Inc. “Combining package design, prototyping, development and testing services reduces the risk of packaging failing to meet industry requirements.”
Minneapolis, MN, December 6, 2006 – http://www.testedandproven.com – DDL Inc, a leading medical device package, product and material testing laboratory, has been named the #42 fastest growing company in the Twin Cities in a recent Growth 50 honor roll released by the Minneapolis St. Paul Business Journal.
DDL, which has experienced an average annual revenue increase of 25% since 2003, has moved up 8 places from its #50 position in the 2005 Growth 50. DDL attributes much of its growth to its ability to read the needs of its customers.
“Many package engineers and manufacturers are looking for re-assurance that their packaging will not fail its validation testing,” said Patrick Nolan, COO of DDL Inc. “DDL offers comprehensive pre-testing consultation via our PackAdvice service pledge, so that the customer feels that the packaging is properly prepared for its testing.”
In 2006, important revisions were made to ISO 11607, the foremost guidance document for medical device package testing. DDL helped prepare and guide packaging professionals through these revisions with a series of 3 webinars. DDL has also just launched its “Industry Standards Alert” service, which invites industry professionals to sign up to receive a notification by email or by RSS feed when an industry standard is updated.
Minneapolis, MN, October 17, 2006 – http://www.testedandproven.com – DDL, a leading package testing services firm specializing in medical device package testing, has launched a brand new “Industry Standards Alert” service to help package engineers and manufacturers keep up-to-date on changing industry requirements.
DDL has been heavily involved in the revision of several industry standards. COO, Patrick Nolan, is part of the Task Group that developed the revised Technical Information Report (TIR) for the new ISO 11607-01 standard.
“DDL believes that it is really important for packaging professionals to be aware of revisions to all industry standards, including ISO 11607,” said Nolan. “Understanding potential changes to requirements can mean the difference between pass and fail when it comes to package validation.”
John Hart, CEO of DDL Inc., will deliver a presentation on the “ISO 11607 Revisions” at the upcoming MD&M Minneapolis conference, October 24 – 26, 2006.
The presentation will discuss the changes to Clause 6, the most affected part of the standard, and how manufacturers and packaging professionals can prepare themselves for a package validation under ISO 11607-01.
Package, product and environmental testing laboratory, DDL Inc, opens an additional environmental testing laboratory to meet increased demand for testing services.
Minneapolis, MN, May 31, 2006 — http://www.testedandproven.com/ - DDL, a leading package, product and environmental testing laboratory, is expanding into a second environmental testing laboratory.
The facility, in Eden Prairie, MN, will act as an overflow as the company expands, allowing the widely recognized thought leaders in the field of package, product and environmental package testing to take on more projects and respond to an increase in demand.
“The new environmental testing laboratory will allow us to take on 25% more environmental testing projects per year,” said John Hart, CEO of DDL Inc. “This also frees up more space in our main testing lab, allowing us to increase the number of other DDL package, product and material testing projects.”
Environmental testing involves exposing a package or product to controlled temperatures and humidity in order to reproduce the conditions that the package/product is expected to survive in its transportation, storage and operating life. After exposure, the package or product is assessed for damage.
Minneapolis, MN, April 21, 2006 — http://www.testedandproven.com/ - DDL, a leading package, product and material testing services firm, has launched a new website to offer manufacturers and packaging professionals an interactive educational resource.
DDL recognizes that many manufacturers and packaging professionals are unable to keep up-to-date with changing compliance requirements and the implications for the testing of their package or product. DDL has re-designed its website to better serve the industry with educational information that will keep them on top of compliance.
“The package testing industry is continually changing,” said Patrick Nolan, COO of DDL, “DDL will be able to keep industry professionals up-to-date on the latest industry standards and testing requirements via advanced features now available on its website.”
DDL is currently running a series of three webinars on the forthcoming ISO 11607 revisions. These revisions will impact compliance requirements for package validation and the distribution of medical devices.
DDL also offers a free PackReview startup kit to manufacturers looking to validate their package in compliance with ISO 11607 (clause 7).
Minneapolis, MN, March 16, 2006 — http://www.testedandproven.com - Package testing expert, Patrick Nolan, COO of DDL, a leading package, product and material testing laboratory, has been elected Chairman of the ASTM Committee D-10 on Packaging.
The American Society for Testing & Materials (ASTM) created the D-10 on Packaging Committee in 1914 to discuss the revision and development of regulated packaging standards.
“I am thrilled to be Chairman of the D-10 committee,” said Patrick Nolan, COO of DDL. “By being actively involved in the development of packaging standardization, I am in a position to offer the best knowledge and quality of service to DDL’s package testing customers.”
As Chairman of the D-10 Committee on Packaging, Nolan will be responsible for leading the twice yearly committee meetings that involve attending various technical sessions over a two day period.
During the meetings, the committee is charged with the following tasks:
1) Defining materials and processes for acceptable package and product delivery.
2) Generating closely related shipping systems design criteria.
3) Developing materials handling standards related to distribution, including
measurement of the packaging environment.
4) Assessing the suitability of packaging related standards.
5) Establishing standards on reuse, recycling and disposal of materials related to
packaging.
Minneapolis, MN, February 27, 2006 — http://www.testedandproven.com/11607-webinar.html - DDL, a leading package, product and material testing laboratory, is hosting a series of free webinars on how upcoming revisions to the ISO 11607 standard will impact packaging professionals.
ISO 11607 is the foremost guidance document for validating packaging for terminally sterilized medical devices. The proposed revisions will mean a change in compliance requirements for package testing and validation.
“DDL wants packaging professionals to be aware of the upcoming changes to the ISO 11607 standard,” said Patrick Nolan, COO of DDL. “Understanding the imminent revisions could mean the difference between pass and fail when it comes to package validation.”
The first webinar, “ISO 11607 Revisions,” presented by Patrick Nolan, COO of DDL Inc, will cover the following:
- Background on the ISO 11607 standard
- Overview of the proposed revisions
- How the revisions will affect requirements for
o Quality Systems
o Sampling Plans
o Documentation
o Sterilization
o Labeling
o Storage & Transport
o Test Methods
- Details and implications of revisions to Clause 6.
