Updates have been made to the following ASTM Standards:

D Category

D6272 - Standard Test Method for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials by Four-Point Bending has been reapproved (with editorial change), available as D6272-02(2008)e1

F Category

F2622 - Standard Test Method for Oxygen Gas Transmission Rate Through Plastic Film and Sheeting Using Various Sensors has had an epsilon edit, available as F2622-08e1

Work Order Category

WK20548 - Standard Test Methods for Measurement of Torque Retention for Packages with Continuous Thread Closures is a work item revision to existing standard D2063-91(2002)

ShareThis

Updates have been made to the following ASTM Standards:

D Category

D1229 - Standard Test Method for Rubber Property-Compression Set at Low Temperatures has been reapproved, available as D1229-03(2008)

D202 - Standard Test Methods for Sampling and Testing Untreated Paper Used for Electrical Insulation has been revised to D202-08

D395 - Standard Test Methods for Rubber Property—Compression Set has been reapproved, available as D395-03(2008)

D3767 - Standard Practice for Rubber—Measurement of Dimensions has been reapproved, available as D3767-03(2008)

D6049 - Standard Test Method for Rubber Property-Measurement of the Viscous and Elastic Behavior of Unvulcanized Raw Rubbers and Rubber Compounds by Compression Between Parallel Plates has been reapproved, available as D6049-03

E Category

E18 - Standard Test Methods for Rockwell Hardness of Metallic Materials has been revised to E18-08a

F Category

F1148 - Standard Consumer Safety Performance Specification for Home Playground Equipment has been revised to F1148-08

F2085 - Standard Consumer Safety Specification for Portable Bed Rails has been revised to F2085-08

F2097 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products has been revised to F2097-08

Work Order Category

WK20341 - Standard Test Method for Shear Testing of Aluminum Alloys is a work item revision to existing standard B769-07

WK20351 - Standard Test Method for Measuring the Force-Displacement of a Membrane Switch is a work item revision to existing standard F2592-07a

WK20357 - Standard Test Method for Apparent Shear Strength of Single-Lap-Joint Adhesively Bonded Metal Specimens by Tension Loading (Metal-to-Metal) is a work item revision to existing standard D1002-05

ShareThis

Healthcare Packaging
Article Summary

Karen Greene, CPP, technical director, DDL Inc., a provider of testing services, package design, prototyping, and consulting, noted that compliance with Intl. Standards Organization standard 11607 “is a must in this FDA-regulated industry.” The 11607 standard is a harmonized, globally accepted industry standard for terminally sterilized medical devices. TIR (Technical Information Report) 22 is a guidance document to comply with ISO 11607, she explained. Greene recommended that device makers see if their company’s data can be leveraged and used in compliance. “A thorough package compliance program is a competitive advantage for your company,” she said.

ShareThis

Today’s presentation, “The Compliance Sweet Spot,” to share powerful methodologies for medical device packagers to achieve the perfect balance between compliance and time to market

Minneapolis, MN  – June 2, 2008 – http://www.testedandproven.com/ - DDL, the leading package testing services firm specializing in medical device package testing, will be represented today in New York City at MD&M East, and will help kick off the conference, with a powerful presentation by DDL West Technical Director Karen Greene.

Greene’s presentation, “The Compliance Sweet Spot”, outlines key activities designed to ensure  those in the medical device package testing industry discover the perfect balance between packaging compliance and competitive time to market.

“A goal of ours at DDL Inc. is to educate our customers on the requisite compliance standards and regulations, through effective, industry proven methodologies, and to quickly move them through the compliance stage on the way to market,” states Greene.

The most vital packaging standard requiring compliance, ISO 11607, is heavily referenced in Greene’s presentation, as is its “how to” guide the TIR 22.  Greene’s presentation, in fact, is most geared towards attendees who not only must comply with ISO 11607, but are relatively unfamiliar with its details.
Key takeaways attendees can hope to learn from Greene today are:

• An understanding of why the TIR 22 was developed, and how to effectively follow it
• A deeper awareness of package design and development activities and the resultant benefits of facilitating speed to market
• A strategy for quickly developing, qualifying and launching a safe, effective and world class medical device packaging system

“I am very pleased to have been selected to speak at MD&M East,” continues Greene.  “I look forward to ensuring today’s attendees leverage what I have learned from my experience in package design, testing and consulting to efficiently launch their medical device packaging system.”

Greene’s presentation, The Compliance Sweet Spot, will be presented at 9am EST today at MD&M East being held in the Jacob K. Javits Convention Center in New York City.

About DDL (www.testedandproven.com)
DDL offers expert package testing, product testing and material testing services including shock testing, vibration testing, tensile testing, leak testing and validation services. Additionally, DDL provides expert package design, development and prototyping services for those clients who desire to outsource their package development function. 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 6). DDL Testing Services maintains full service testing labs in Minnesota and southern California. DDL’s package design, development and prototyping services are offered to support national clients through staff and operations based in southern California.

ShareThis

At DDL, our objective with this blog is to allow for far greater, far more meaningful conversations with clients, prospects, and industry friends like you than we had ever before thought possible.

Via comments left below, or thoughts shared with us later, we feel that we’ve helped build a forum where we can educate each other on what we truly care about – continued growth and development of the packaging industry.

Now, we’d like you to not only share what you think with us, but with a much larger audience.

At regular points throughout the year, we will open up DDL’s blog to guest posts from those of you in the packaging industry. Posts will be subject to approval, but will not be modified in any way.

What will we accept posts about?
Anything you have unique insight on, of course!

Here are a few ideas to get you started:

• What are your greatest packaging challenges today?
• What is the most unique package design you’ve ever considered for your product?
• What is most important to your firm when working with a package testing and design consultant?
• What changes do you feel are necessary for our industry to truly embrace the concept of sustainability?

Ideas are welcome from anyone in the industry, at any level, and may be submitted via the comments below.

Those chosen to be a guest blogger will be alerted via a follow-up message to the board below, and be instructed
to contact DDL via our corporate contact us page.

Hope to hear from you soon!

ShareThis

Operating your business in a tough economy is certainly nothing any business owner or high level executive relishes.

In a previous post, I discussed how firms like DDL, who exist in the package testing and medical device testing services arenas, are relatively sheltered during these times. However, this is in no way meant to indicated that we do not experience – and in some sense have to refine our strategy – to ensure success.

This afternoon, along with a panel that includes Kay Kuba, CEO of GCI Systems Inc., Tony Sorenson, owner of The McKinley Group Inc., and Kristin Christian, manager of DASCO Systems, I will be representing DDL and sharing some of the operating plans DDL has, and continues to, employ, to help ensure continued success regardless of the fluctuations seen in the overall economy.

The event runs from 3pm-7pm today at the Earle Brown Heritage Center at 6155 Earle Brown Dr in Brooklyn Center and registration can be completed online.

For anyone unable to attend, visit this forum later this week for a summary and overview of the panel discussion.

ShareThis

Critical ISO 11607 clause 6 compliance questions answered in three chapter webinar series

Minneapolis, MN – April 18, 2008 – http://www.testedandproven.com/ DDL, the leading package testing services firm specializing in medical device package testing, has reintroduced a webinar series, originally recorded in 2006, designed to ensure packaging professionals both understand and stay in compliance with ISO 11607 – clause 6.

“How Will ISO 11607 Revisions Affect Packaging Professionals?” is aimed at packaging professionals who are not only concerned that they don’t have an adequate understanding of recent ISO 11607 clause 6 revisions, but also fear that the compliance methodologies specific to their companies may be falling out of date.

“DDL recorded this series in 2006, to help prepare the industry for compliance with upcoming published revisions to ISO 11607 clause 6,” states Patrick Nolan, COO of DDL and the webinar series host. “Nearly two years later ‘Am I in compliance with ISO 11607?’ is one of the most common questions I find myself being asked.”

Despite published revisions being in place for nearly two years, understanding and ensuring compliance can be an everyday challenge for packaging professionals. Much of this challenge stems from how to apply these revisions to specific industries and changing marketplace trends, such as the move to environmentally friendly sustainable package design.

Throughout, each of the series three chapters, the listener is provided not only a strategic approach to understanding ISO 11607 clause 6 revisions, but testing methods that can be applied to specific industries and evolving business practices.

“ISO 11607 clause 6 compliance, while extremely critical, is not something that should require an overwhelming amount of time to ensure,” continues Nolan. “While questions will be ever-present, many can be answered efficiently through with a strategic overview and proven testing methods.”

The reintroduced webinar series “How Will ISO 11607 Revisions Affect Packaging Professionals?” is available by visiting DDL’s website.

About DDL (www.testedandproven.com)
DDL offers expert package testing, product testing and material testing services including shock testing, vibration testing, tensile testing, leak testing and validation services. Additionally, DDL provides expert package design, development and prototyping services for those clients who desire to outsource their package development function. 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 6). DDL Testing Services maintains full service testing labs in Minnesota and southern California. DDL’s package design, development and prototyping services are offered to support national clients through staff and operations based in southern California.

ShareThis

Last month, I was happy to represent DDL at ISTA’s first annual International Transport Packaging Forum. While I was presenting” Laboratory Practices for Optimal Thermal Gel Design and Specification” DDL’s own Mike Woletz, Packaging Engineer and Project Manager, was attending multiple presentations, networking, and since the event was held at Disney’s Coronado Springs Resort, most likely having a little bit of fun.
It is my pleasure to introduce below a guest post from Mike Woletz sharing his thoughts on the first annual International Transport Packaging Forum:

The name may have changed, but the tradition continues. Last month ISTA presented the first annual International Transport Packaging Forum in Orlando, Florida. Previously known as Dimensions, the International Transport Packaging Forum attracted packaging professionals from around the globe, and a good number of students and instructors from well-known packaging schools.

Topics discussed during 2008 ISTA International Transport Packaging Forum were current and diverse, from global standards for medical packaging to the aircraft transport environment and I would like to thank all of the presenters for their informative presentations.

Though varied, many of the presentation topics related, either directly or indirectly, to services DDL provides. I would like to highlight some of the common themes and give my impressions of a few of the concepts that directly affect DDL and our customers.

Reviewing the validity of various vibration spectrums became a reoccurring theme. Presentations by UPS Customer Service, Lansmont Corporation, ISTA, The Hershey Company, and San Jose State University delved into the complexities of creating and implementing vibration testing representative of actual vibration seen during transport.

A variety of viewpoints on the subject were offered, some nearly opposing. Bill Kipp of ISTA gave the attendees new vibration testing variables to consider, such as ‘shock on vibe’ testing and running the high and low amplitude spectra separately.

Eric Joneson of Lansmont Corporation, through his recent and original research, purposed that current air vibration testing is not representative of the actual stresses seen during air transport; the current air vibration standards are too severe.

Herb Schueneman of San Jose State University provided data supporting the conclusion that the specific vibration spectrum is of no consequence, only the intensity and whether or not the test specimen is coupled to the source of vibration (vibration table). Mr. Schueneman believes that accelerated vibration testing cannot accurately simulate the transport environment and that all vibration testing should be conducted in real-time, i.e. if a package sees 10 hours of transportation, the package should be exposed to 10 hours of lab vibration testing.

Several of the ideas presented, to me, seem quite speculative and would require further research prior to consideration in vibration test standard revisions. I thought Eric Joneson’s air vibration study was quite sound. I believe, after completion of additional data gathering, we could, and should, see a change in the ASTM D4728 air spectrum vibration test within a few years.

Sustainability was, again this year, a popular topic at the forum. Sealed Air, Sam’s Club, and IBM presented on topics of environmental impact and sustainability.

Bill Armstrong of Sealed Air explained the history of the sustainability movement and how it has, and will, affect distribution packaging.

Bob Sander from IBM introduced a carbon footprint model inclusive of IBM’s entire distribution process and their effort to reduce emissions beyond the current regulations. A notable presentation detailing the Wal-Mart/Sam’s Club ‘Packaging Scorecard’ was given by Robert Parvis of Sam’s Club.

The ‘Packaging Scorecard’ is a tool that has been implemented by Wal-Mart/Sam’s Club buyers to evaluate the sustainability of their suppliers’ packaging and to help reach their goal of reducing packaging across the global supply chain 5% by 2013. This initiative will reward sustainable packaging and process innovation.

The scorecard metrics will consist of eight weighted criteria: GHG/CO2 per ton of production, material value, product/package ratio, cube utilization, transportation, recycled content, recovery value, and renewable energy. Obviously the scorecard covers a broad range of processes that affect sustainability, and, due to Wal-Mart/Sam’s Club’s size, will affect the way many organizations consider their packaging and distribution methods.

Some organizations need to be pushed toward environmental considerations, some will do the pulling; regardless, sustainability will prove more than a fad. I see Wal-Mart/Sam’s Club’s initiative to be the beginning of a compounding trend that will effectively see organizations taking the lead in sustainability issues, outpacing government controls and regulations.

While the packaging industry is often criticized by environmentalists, as Dr. Diana Twede of the MSU School of Packaging explained to forum attendees during her history of transportation packaging presentation, packaging is a necessary function relevant in our history and important to our future.

It should be noted that many organizations are taking charge of their packaging functions in efforts to mitigate their impact on the environment, while at the same time seeing a cost benefit. It has become evident, increasingly so, that environmental conscious, sustainable packaging processes and a healthy bottom line are not mutually exclusive.

This concept is working its way into the packaging industry psyche, so as, increasingly, the packaging engineer will not just ask “will this package perform as we need it to,” but “will this package perform as we need it to and meet our sustainability goals.”

DDL’s own Karen Greene and Anthony Alleva of TCP Reliable, Inc., came together to share the findings of their thermal gel pack design and specification study. The study evaluated performance differences relative to design and configuration of refrigerants in both insulated and un-insulated shippers. Their collaborative effort showcased the respective expertise of both DDL and TCP Reliable, as well as our combined presence in the industry.

I would like to express my thanks to ISTA for putting together a top-notch event and the staff at the Disney Coronado Springs Resort for catering to the needs of the large number of attendees.

Next year the ISTA International Transport Packaging Forum will be located in Las Vegas! No doubt it will be as informative and enjoyable as this year’s forum. I hope to see you there.