Package and Product Integrity Blog

DDL, Inc. will be exhibiting at the 2011 MD&M Minneapolis Expo & Conference next month in the Twin Cities. The show kicks off with the conference on November 1st at the Minneapolis Convention Center.

MD&M Minneapolis’ Expo hall maximizes your time by gathering the world’s best and most qualified suppliers under one roof. They know your industry, understand your objectives, and are ready to help you bring that new device to market and accelerate your project’s completion

DDL’s Lead Packaging Engineer Scott Levy is a co-chair of the Medical Device Packaging Update at the conference on Thursday, November 3rd. We invite you to join Scott, along with co-chair Kevin Zacharias of Oliver-Tolas Healthcare Packaging for an update on happenings in the medical device packaging industry.

DDL will be exhibiting at booth #830 during the expo, where you will have an opportunity to talk to Scott Levy about any current and upcoming package testing projects.

We look forward to seeing you at this year’s show. If you have any questions regarding your package testing needs, please contact us, we are happy to help answer your questions.

DDL will be exhibiting at the 2011 MD&M East Expo & Conference next month in New York City. The show kicks off with the conference on June 6th at the Jacob K. Javits Convention Center.

MD&M East’s Expo hall maximizes your time by gathering the world’s best and most qualified suppliers under one roof. They know your industry, understand your objectives, and are ready to help you bring that new device to market and accelerate your project’s completion

DDL’s Lead Packaging Engineer Scott Levy is a co-chair of the Medical Device Packaging Update at the conference on Wednesday, June 8th. We invite you to join Scott, along with co-chair Kevin Zacharias of Oliver-Tolas Healthcare Packaging for an update on happenings in the medical device packaging industry.

DDL will be exhibiting at booth #1969 during the expo, where you will have an opportunity to talk to Scott Levy about any current and upcoming medical packaging projects.

We look forward to seeing you at this year’s show. If you have any questions regarding your package testing needs, please contact us, we are happy to help answer your questions.

MD&M Florida is this week and we wanted to invite those of you that are still considering coming to MD&M Florida, to use DDL’s promo code when you register for the event.

MD&M Florida is part of the nation’s premier conference series for research and development, design, engineering, manufacturing, and regulatory affairs professionals within the medical manufacturing industry. In addition to the conference there is an exhibition hall of suppliers that support the medical device industry.

 

DDL will be exhibiting at booth #432, so please stop by and ask us about the latest updates to testing standards or any questions that you have with any upcoming projects. We look forward to seeing those of you that will be attending MD&M Florida this week.

 

DDL will be exhibiting next week at the LifeScience Alley Conference & Expo at the Minneapolis Convention Center. Feel free to stop by and say hello to us at booth #706.

Who Should Attend?

The LifeScience Alley® annual conference brings together global leaders in the life science and health care industry to identify trends, share expertise, and network across disciplines. The goal of this gobal conference is to equip attendees with information and resources that will help them stay ahead of the “Health
Tomorrow” curve. This is a place where science and business converge to uncover hidden challenges and identify new areas of opportunity. (LifeScience Alley)

LifeScience Alley presents an opportunity to meet and connect with life science industry leaders and to attend one of the many seminars or keynote presentations that will discuss current trends and innovations in the life science industry.

The event is next Wednesday, December 8th starting at 8:00 am with a Breakfast General Session.

Click here to register for LifeScience Alley.

Hopefully we will see many of you at the show next week, it should be a great day to bring together many businesses that help support, innovate and grow the life science industries.

As a medical device manufacturer, one of the most important steps in the FDA approval process for a device is evaluate each package’s ability to protect the product inside throughout the handling, distribution, and storage environment.

The manufacturer must demonstrate that, under the rigors of distribution, storage, handling, and aging, the sterile package integrity is maintained at least for the claimed shelf life of the medical device or product.

There are many important questions you should be asking your packaging engineers internally, if you do your own testing, or that you should be asking of a third party testing laboratory. Here are 5 questions to ask a medical packaging engineer before you conduct your next package testing project.

1. Which technical standards does your testing laboratory comply with?
2. Are the standards that we are currently using or about to utilize in compliance with ISO 11607?
3. What are the material characteristics in the package design?
4. How is the device sterilized?
5. What is the worst case packaging configuration to use for a final package performance validation?

As a medical device manufacturer, what other questions do you make sure to ask of your packaging engineers in house, or of your preferred testing laboratory?

What makes packaging doubly important is that regulatory authorities recognize the critical nature of sterile barrier or primary package by considering them components or accessories to the medical device. This implies that packaging is almost as important as the device itself. And it is. If a package does not keep, for instance, a pacemaker sterile, patients will be put at risk.

The design and development of packaging has rightfully come under closer scrutiny by international and domestic regulatory agencies. This scrutiny has placed a great deal of emphasis on standardizing package development. Some standardization comes in the form of the international standard ISO 11607: Packaging for terminally sterilized medical devices.

As critical as packaging is, some companies occasionally don’t take it seriously. They’ll consider it late in the design cycle, cut corners, or use inappropriate materials.

In part 1 of 2 posts on the ten common mistakes companies make when developing and validating packaging systems for terminally sterilized (inside a closed package) medical devices, here are the first five.

1. Loss of sterile integrity
This is the most common defect in medical packaging and can happen from fractured thermoforms along with pinholes, slits, cuts, and tears in pouch packages. These defects come from handling (or mishandling), vibrations during transportation, storage, and impacts caused by dropping.

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DDL earned a spot on this year’s Minneapolis/St.Paul Business Journal’s Fast 50 for the fourth year.

DDL, along with 49 other privately held Twin Cities companies, gathered at the Nicollet Island Pavillion near St. Anthony Main last Thursday to await the announcement of Minneapolis/St.Paul Business Journal’s Fast 50. DDL ranked number 36 on the list.

DDL placed 50^th on the Fast 50 list in 2005,  42^nd in 2006, 27^th in 2008 and 37th this year.

As a company of 20 employees from the beginning in 1990 until 2003, we have since more than doubled our number of employees and increased revenue with a 62 percent growth from 2006-2008.

The Fast 50 rankings are based on the percentage of growth in revenues in the three-year period from 2006-2008.  Companies must be privately held and based in the 11-county Twin Cities metro area.  Firms are required to have $1 million in revenue in the first year and progressive growth in the following two years. All applications were reviewed and audited by Baker Tilly, a full-service accounting and advisory firm out of Minneapolis for verification.

DDL is honored to haven been acknowledged as one of the Twin Cities most prosperous companies and we would like to congratulate all candidates. We only hope that our success and the success of others continue in the upcoming years.

Here is the full list of companies from the Minneapolis/St. Paul Business Journal’s Fast 50 2009.

DDL had a great time last week at the MD&M Minneapolis show at the Minneapolis Convention Center, which showcased companies as resources in the  medical product development and manufacturing process. We were able to see many clients and meet a lot of new faces, all in all, it was a good trade show.

Scott Levy, one of our Packaging Engineer’s  spoke in front of a full house as part of the conference on Thursday, the topic of Scott’s presentation was Distribution Simulation Testing.

There were many medical device manufacturers that attended and exhibitors included companies in toxicology, biotech, pharma, mid-pack and medical device.

If you missed us at MD&M Minneapolis, we will be at BIOMEDevice in San Jose at the beginning of December, or you can connect with us before then by contacting us.

MD&M Minneapolis starts this week and our own Scott Levy will be kicking off the conference with a presentation on “Distribution Simulation Testing.”

Distribution Simulation is a uniform way of evaluating shipping units through the use of laboratory equipment that subjects the packaging system to specific hazards that may occur within the anticipated distribution environment. Understanding the methodologies behind the processes is vital for medical device manufacturers to get their product to market.

Scott’s presentation will focus on, “Distribution Simulation Testing”, outlining key activities designed to educate those in the medical device package testing industry on the importance of distribution simulation and the current industry trends.

The recent ASTM F2 Committee meeting was held in a unique location…Prague, Czech Republic, and I was fortunate enough to represent DDL at the meeting. Regardless of the remote location, the meeting included about 18 US representatives and 20 European representatives. All representatives attended the regular meeting of the committee as well as the workshop on “Flexible Barrier Packaging Test Methods as International Standards.”

The meeting agenda included regular subcommittee meetings of the F2 Committee with most of the discussion revolving around dye penetration leak test methods and environmental stressing of packaging. Some of the highlights included: modifying Test Method F1929, developing new standards for dye penetration and discussion on a method for evaluating the quality of seals in plastic cups with heat sealed lids.

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