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ISO 11607 Revisions Webinar from DDL Describes Changing Requirements for Distribution of Medical Devices

Friday, April 28th, 2006

Minneapolis, MN, April 28, 2006 http://www.testedandproven.com/webinars.html – DDL, a leading medical device package testing laboratory, is hosting the second of three free webinars on the upcoming revisions to the ISO 11607 standard – “Packaging for Terminally Sterilized Medical Devices.”The second ISO 11607 Revisions webinar from DDL, “Understanding Clause 6,” delves into clause 6 of the standard which focuses on a package’s ability to deliver a medical device to the patient without jeopardizing sterility or incurring defect.“Safe and sterile distribution of a medical device to the end-user is critical,” said Patrick Nolan, COO of DDL. “Changes to ISO 11607 Clause 6 are intended to improve this process, but industry pro’s that do not understand compliance changes may find that their package or product fails when it comes to the testing lab.”“Understanding Clause 6” presented by Patrick Nolan, COO of DDL Inc, will cover how revisions to ISO 11607 Clause 6 will change compliance requirements for the following:• Test methods• Sampling plans• Materials & performed sterile barrier systems• Storage & transport regulations• Closure/seal evaluation• Accelerated aging protocols“Clause 6 will be the most changed out of all the ISO 11607 revisions,” said Nolan, “for example, an entire section will be added on the requirements for sterile fluid pathways.”The “ISO 11607 Revisions – Understanding Clause 6” webinar will air on three different dates:• May 17, 2006, 12 PM CST (1 EST, 10 PST)• May 23, 2006, 1 PM CST (2 EST, 11 PST)• May 25, 2006, 2 PM CST (3 EST, 12 PST)Register for the “ISO 11607 Revisions – Understanding Clause 6” webinar athttp://www.testedandproven.com/webinars.htmlYou can also listen to the first webinar in this series on the ISO 11607 Revisions on-demand at http://www.testedandproven.com/webinars_ondemand.htmlAbout DDLDDL offers expert package testing, product testing and material testing services including shock testing, vibration testing, tensile testing, leak testing and validation. DDL package testing clients find value through its growing suite of PackServices: PackAdvice, a zero-cost package testing consulting service, and PackReview, a DDL approved certification to demonstrate compliance with ISO 11607 (clause 7). DDL Testing Services maintains full service testing labs in Minnesota and California. http://www.testedandproven.com

Package Testing Services Firm, DDL, Launches New Website As Educational Resource for Manufacturers&Packaging Professionals

Friday, April 21st, 2006

Minneapolis, MN, April 21, 2006http://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.”The new DDL website includes the following features:•    On-demand webinars•    Industry standards search capability•    Articles download•    PackReview startup kitDDL 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).“Manufacturers understand that they need to comply with industry standards, but the finer details can often be confusing,” said John Hart, CEO of DDL. “DDL’s PackReview startup kit is a concise, clear instruction manual on what manufacturers need to do to comply with ISO 11607 (clause 7).”You can visit the new DDL website at http://www.testedandproven.comRegister for the DDL on-demand “ISO 11607 Revisions” webinar at http://www.testedandproven.com/webinars_ondemand.html About DDL DDL offers expert package testing, product testing and material testing services including shock testing, vibration testing, tensile testing, leak testing and validation. DDL package testing clients find value through its growing suite of PackServices: PackAdvice, a zero-cost package testing consulting service, and PackReview, a DDL approved certification to demonstrate compliance with ISO 11607 (clause 7). DDL Testing Services maintains full service testing labs in Minnesota and California. http://www.testedandproven.com

Package Testing Lab COO, Patrick Nolan, Becomes Chairman of ASTM Committee D-10 on Packaging

Thursday, March 16th, 2006

Minneapolis, MN, March 16, 2006http://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, includingmeasurement of the packaging environment.4) Assessing the suitability of packaging related standards.5) Establishing standards on reuse, recycling and disposal of materials related topackaging.“The development of packaging standards is a lengthy process,” said Nolan. “The committee has much to discuss about terminology, practices, test methods, specifications, guides and classifications.”Patrick Nolan will Chair his first D-10 on Packaging Committee meeting in April 2006. About DDL DDL offers expert package testing, product testing and material testing services including shock testing, vibration testing, tensile testing, leak testing and validation. DDL package testing clients find value through its growing suite of PackServices: PackAdvice, a zero-cost package testing consulting service, and PackReview, a DDL approved certification to demonstrate compliance with ISO 11607 (clause 7). DDL Testing Services maintains full service testing labs in Minnesota and California. http://www.testedandproven.com

Package Testing Lab, DDL, Hosts Series of Webinars on ISO 11607 Revisions – DDL Helps Packaging Pro’s Comply with New Requirements

Monday, February 27th, 2006

Minneapolis, MN, February 27, 2006http://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 foro Quality Systemso Sampling Planso Documentationo Sterilizationo Labelingo Storage & Transporto Test Methods- Details and implications of revisions to Clause 6.“Clause 6 of the ISO 11607 standard will encounter the biggest changes,” said Nolan. “Clause 6 is particularly important to packaging professionals because it provides the provisions for determining a package’s ability to deliver the enclosed medical device to its final destination without incurring defect.”The first ISO 11607 Revisions Webinar will air on four different dates:• Thursday, March 9, 2006 at 1 pm EST• Friday, March 10, 2006 at 2 pm EST• Wednesday, March 15, 2006 at 12 pm EST• Thursday, March 16, 2006 at 11 am ESTRegister for the ISO 11607 Revisions Webinar at http://www.testedandproven.com/11607-webinar.html About DDL DDL offers expert package testing, product testing and material testing services including shock testing, vibration testing, tensile testing, leak testing and validation. DDL package testing clients find value through its growing suite of PackServices: PackAdvice, a zero-cost package testing consulting service, and PackReview, a DDL approved certification to demonstrate compliance with ISO 11607 (clause 7). DDL Testing Services maintains full service testing labs in Minnesota and California. http://www.testedandproven.com

ISO 11607 Revisions Will Impact Packaging Compliance Requirements – Package Testing Expert, DDL, Offers Advice to Packaging Pro’s

Thursday, January 26th, 2006

Minneapolis, MN, January 26, 2006http://www.testedandproven.com – DDL, a leading package, product and material testing services laboratory, is offering advice to packaging professionals as to how ISO 11607 revisions will affect their business.

DDL COO, Patrick Nolan, is involved in the AAMI/ANSI/ISO Sterilization Packaging Working Group, which is responsible for drafting the Technical Information Report (TIR) for the ISO 11607 revisions.

“It is really important that packaging manufacturers and engineers understand just how the ISO 11607 revisions will affect compliance requirements for their packaging,” said Nolan. “Even small changes to sample size requirements can significantly impact the package validation process.”

The proposed revisions will affect the following aspects of package testing and validation:
• Sample requirements
• Testing methods used
• Requirements for validation
• Documentation
• Labeling

DDL Package Engineers are offering a free PackAdvice consultation service to their package testing customers to ensure that they understand the compliance implications of the revised standard.

“Many manufacturers find the package validation process confusing as it is,” said Nolan, “DDL plans to make the change in compliance requirements as smooth as possible for its customers, while making sure they clearly understand how their business will be affected.”

Package Testing Services Firm, DDL, Sponsors“Relay for Life”Team for Cancer Awareness Charity

Thursday, November 10th, 2005

Minneapolis, MN, November 10, 2005 -– DDL Inc. (http://www.testedandproven.com ), a leading package, product and material testing laboratory, is taking an active role in raising money for Cancer research by sponsoring an American Cancer Society’s Relay for Life team.The Relay for Life charity, which was founded 20 years ago, asks groups of participants to gather at schools, fairgrounds and parks and run/walk laps in order to raise money for Cancer research.DDL recently raised money for the charity by sponsoring the “Walkie Talkies” Relay for Life team at a local Minneapolis school event.“It’s great to see how far the Relay for Life charity has come over the last 20 years,” said Patrick Nolan, COO, DDL. “More than 3 million Americans now participate in Relay for Life events nationwide.”DDL’s participation in the Relay for Life activities is in line with the package testing services company’s core values and emphasis on both professional and personal development.“At the last event, our team raised $6,000 for Cancer research,” said Patrick Nolan. “We hope that DDL can continue to contribute to such a great cause.”Find out more information about the American Cancer Society and participate in a Relay for Life event in your area: http://www.cancer.org/docroot/GI/content/GI_1_1_How_to_Participate.aspAbout DDLDDL offers expert package testing, product testing and material testing services including shock testing, vibration testing, tensile testing, leak testing and validation. DDL package testing clients find value through its growing suite of PackServices: PackAdvice, a zero-cost package testing consulting service, and PackReview, a DDL approved certification to demonstrate compliance with ISO 11607 (clause 7). DDL Testing Services maintains full service testing labs in Minnesota and California. http://www.testedandproven.com

DDL Expands Intravascular Medical Device Testing Services—Offers“One-Stop”for Package, Product&Materials Testing

Tuesday, November 1st, 2005

Minneapolis, MN, November 1, 2005 — http://www.testedandproven.com — DDL, a leading package, product and materials testing services laboratory, has announced the expansion of its intravascular medical device testing services.Manufacturers can now use DDL’s one-stop package, product and materials testing services to certify medical devices such as catheters, syringes, needles, cannulae and other intravascular applications.“The critical nature of these devices means that confirming performance, sterility and integrity is vital,” said John Hart, CEO, DDL. “DDL is an expert in testing the medical device’s product, materials and packaging to ensure that the patient receives a reliable and sterile end product.”DDL performs the following types of testing services on intravascular medical devices such as catheters, in conformance with ISO standards:• Strength Testing• Luer Gauging and Performance Testing• Flow Rate Testing• Stress Testing“As far as I know, DDL is the only testing services laboratory to offer product, materials and package testing all rolled into one service,” said Hart. “DDL customers really appreciate the convenience of being able to rely on DDL for all of their testing needs.”To find out more information on DDL’s medical device product, materials and package testing services, visit www.TestedandProven.com or call Scott Levy at 952 941 9226 ext 115.About DDL:DDL offers expert package testing, product testing and material testing services including shock testing, vibration testing, tensile testing, leak testing and validation. DDL package testing clients find value through its suite of PackServices, which include zero-cost package testing consultation, PackAdvice, and DDL approved ISO 11607 certification (clause 7), PackReview. DDL Testing Services maintains full service testing labs in Minnesota and California. http://www.testedandproven.com

Package Testing Services Lab – DDL – Named Top 50 Fastest Growing Company in Twin Cities

Monday, October 24th, 2005

Minneapolis, MN, October 24, 2005 http://www.testedandproven.com – DDL, a leading package, product and material testing services laboratory, has been named a Top 50 fastest growing company by the Twin Cities Business Journal.DDL has experienced record company growth over the last 3 years with a 25 percent annual increase in revenue. DDL attributes its rapid growth to its expansion into California and the development of its suite of PackServices.“DDL currently offers two PackServices to package testing clients,” said John Hart, DDL CEO, “PackAdvice, a free package testing consulting service, and PackReview, which is a DDL approved ISO 11607 (clause 7) certificate of completion.”DDL has also expanded its range of service offerings and its equipment inventory. The DDL West facility, located in Costa Mesa, California, recently hired a Hazmat testing expert to expand its package testing services. DDL West is also upgrading its product and materials testing services.“Hazmat testing is just one area that DDL is becoming more involved in,” said Hart. “We have also seen a significant increase in our medical device testing business. DDL is quickly becoming known as a one stop shop for manufacturers’ package, product and materials testing needs.”View DDL’s profile in the Twin Cities Business Journal Growth 50 feature at http://www.bizjournals.com/twincities/stories/2005/10/17/daily54.htmlAbout DDLDDL offers expert package testing, product testing and material testing services including shock testing, vibration testing, tensile testing, leak testing and validation. DDL package testing clients find value through its suite of PackServices, which include zero-cost package testing consultation, PackAdvice, and DDL approved ISO 11607 certification (clause 7), PackReview. DDL Testing Services maintains full service testing labs in Minnesota and California.Contact DDL at www.TestedandProven.com or call Scott Levy at 952-941-9226 ext.115

Package Testing Lab DDL Urges Co’s To Contribute to Hurricane Relief Effort – DDL HR Director Shares Personal Hurricane Katrina Experience

Thursday, September 22nd, 2005

Minneapolis, MN, September 22, 2005 http://www.testedandproven.com – DDL Inc, a leading package, product and material testing laboratory, has today issued a nationwide plea for U.S. companies to contribute to the Hurricane Katrina relief efforts.For DDL, Hurricane Katrina could not be closer to home. While most Minnesotans have watched from afar, DDL HR Director & Office Manager, Demetria Echols, felt the tragedy first-hand when her 18 year-old son, a freshman at the University of New Orleans, was caught up in the chaos.“My son, Azriel, had moved himself and all of his belongings into his dorm room only a few days before the hurricane hit,” said Echols. “Fortunately, he was able to evacuate to Oklahoma, but his dorm room and everything he owned was destroyed in the flood.”Azriel, like so many of his fellow New Orleans residents, was lucky to walk away with his life. Having transferred to the University of Wisconsin to continue his degree in Forensics, he is reliant upon America’s support to help him re-build his life.“When Azriel returned home, all he had were the clothes on his back,” said Echols. “It’s true that the hurricane has brought out the worst in some people, but I have also witnessed tremendous kindness.”Echols is amazed by and extremely grateful for the kindness her son has encountered. A family friend is collecting donations in her beauty shop and the University of Wisconsin has even agreed to waiver tuition fees for the first semester.“There are so many Americans out there that need our help,” said Patrick Nolan, DDL, COO. “This is why DDL has contributed to the relief efforts and urges other companies and individuals nationwide to do the same.”So far, package testing expert DDL has raised a total of $3,800, including employee donations and corporate matching contributions for the people affected by Hurricane Katrina.Join DDL and contribute to the hurricane relief efforts today at http://www.stormaid.comAbout DDLDDL offers expert package testing, product testing and material testing services including shock testing, vibration testing, tensile testing, leak testing and validation. DDL package testing clients find value through its zero-cost package testing consulting service, Pack-Advice. DDL Testing Services maintains full service testing labs in Minnesota and California. http://www.testedandproven.com###

Package Testing Expert DDL Inc. Experiences Record Company Growth Due to Testing Services Expansion and Growing Suite of PackServices

Friday, September 9th, 2005

Package Testing expert, DDL, is experiencing record company growth, which is being attributed to California expansion and DDL’s growing suite of PackServices.Minneapolis, MN, September 8, 2005 http://www.testedandproven.com – DDL Inc., a MN-based package, product & material testing laboratory, has announced that the company has experienced record company growth over the last 3 years with a 25 percent annual increase in revenue.DDL attributes its growth to its expansion into California with the opening of DDL West and to its growing suite of PackServices, which currently include:- PackAdvice(SM) – Free package testing consulting service- PackReview(SM) – DDL approved ISO 11607 (clause 7) certification“DDL’s PackServices really do provide us with a competitive advantage,” said Patrick Nolan, COO of DDL Inc. “Our PackServices allow DDL package testing customers to reduce time, costs and stress associated with attaining the correct certification for their packaging.”The DDL West facility, located in Costa Mesa, California, recently added a Hazmat testing expert to its team and plans to expand its product and material testing services over the next year.“As DDL continues to expand its testing services and grow its suite of PackServices, we expect DDL’s revenue to continue increasing at a rapid pace,” said Nolan. “We expect 2005 to be DDL’s best year yet with a 27 percent growth over 2004 revenue.”For more information on PackAdvice(SM) and PackReview(SM) services from package testing expert, DDL, visit http://www.testedandproven.com/pack-services.html or call 1.800.229.4235.About DDL Inc.DDL offers expert package testing, product testing and material testing services including shock testing, vibration testing, tensile testing, leak testing and validation. DDL package testing clients find value through its suite of PackServices, which include zero-cost package testing consultation, PackAdvice, and DDL approved ISO 11607 certification (clause 7), PackReview. DDL Testing Services maintains full service testing labs in Minnesota and California.Contact DDL at www.TestedandProven.com or call Scott Levy at 952-941-9226 ext.115# # #

 
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