DDL Part of U.S. Delegation at ISO/TC 122/SC 4 “Packaging and Environment” Meeting 12.10-12.11
I will be traveling to Stockholm, Sweden next week to represent DDL as part of the US delegation heading to Stockholm, Sweden next week for the ISO/TC 122/SC 4 “Packaging and Environment” meeting.
ISO/TC 122/SC 4 “Packaging and Environment” will strive to develop ISO-standards to harmonize environmental aspects on packaging that:
• Reduce the environmental impact of packaging
• Minimize the risk of technical barriers to trade
• Do not conflict with existing standards
The environmental impact of packaging is debated all over the world. Companies, consumers, environmental interests groups and regulatory authorities all have opinions and agendas on the subject. Global ISO-standards on packaging and the environment would provide a common reference that benefit the environment and facilitate international trade.
I will be sharing what I learned when I get back and will write about how the meeting went.
DDL East is now registered with BSI to ISO9001:2008
All three of our labs here at DDL are now under one certificate and one quality system, which will help provide consistent delivery of our tests to our customers for their medical device testing, as well as product and material testing needs.
The registration of our DDL East lab in Edison, NJ, which opened in the late January 2009, was the third and final lab to be registered with BSI to ISO9001:2008.
Top 10 Common Mistakes Companies Make When Developing and Validating Packaging Systems: Part 2 of 2
In continuation of our list from 2 weeks ago, here is the second part of a post highlighting common mistakes made by companies relating to their package validation. Package testing is a crucial component for medical device companies to have done properly to ensure that their packaging is validated for distribution to the market.
6. Having The Wrong Sample Size
The question of the ‘right’ sample size to use for testing is one of the most daunting to answer. There are many factors that weigh into the determination of sample size. The factors include; what type of test is it? (e.g. quantitative/variables or qualitative/attributes); what is the sample population? How many samples are available for testing? What are the economics? What are the risk factors? (e.g. confidence intervals) . Most often the sample size is too small and renders results that have no statistical significance.
The table shows the upper boundary of the expected failure rate when zero or one failure is observed at various sample sizes.
7. Using the Wrong Package Type/Material
Using the wrong package type or material for the product is a package-product compatibility issue, which could have been avoided if pre-qualification of the packaging had occurred at an early stage. Some of the typical observations that are prevalent include fracturing of thermoform trays as a result of using the wrong plastic material for the intended product (e.g. Product mass is too great for the impact resistance of plastic).
This can be avoided for large, massive products, by using a high impact resistant plastic such as polycarbonate to reduce the possibility of fracturing during normal distribution and handling. The thermoform design is also critical to ensure that the product is held in place firmly so that a loose product is not jettisoned through the tray lid and fracturing of the plastic doesn’t occur from the inside-out.
8. Squeezing Oversized Pouches Into Cartons
Pinhole defects in pouches can be reduced by inserting the pouch into a carton without folding, wrinkling or creasing the ends. Pinholes occur at the junctures of the creases and folds when they are vibrated causing the intersection to be ‘worked’ or fatigued at the juncture. This effect is exacerbated by making complex folds of the pouch causing a very concentrated point of stress at the juncture of the materials. This can be circumvented by using secondary packages (cartons/shelf boxes) that are large enough to allow for insertion of the pouch without folding.
This can be avoided for large, massive products, by using a high impact resistant plastic such as polycarbonate to reduce the possibility of fracturing during normal distribution and handling. The thermoform design is also critical to ensure that the product is held in place firmly so that a loose product is not jettisoned through the tray lid and fracturing of the plastic doesn’t occur from the inside-out.
Top 10 Common Mistakes Companies Make When Developing and Validating Packaging Systems: Part 1 of 2
Packaging for medical devices plays a key role in safely delivering specialized treatment to patients. Most single-use, sterilized medical devices can be opened with a high degree of confidence that it has remained sterile throughout storage, handling, and transportation.
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.
DDL Named to Minneapolis/St. Paul Business Journal’s Fast 50
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 Employees John Hart, Tracy Kerber, Lyndsey Danberry and Pat Nolan receiving recognition for being a Minneapolis/St. Paul Business Journal Fast 50 company.
DDL placed 50th on the Fast 50 list in 2005, 42nd in 2006, 27th 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.
MD&M Minneapolis 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.
DDL’s Scott Levy will be Speaking on “Distribution Simulation Testing” at MD&M Minneapolis
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.
- An explanation of the most common methodologies being utilized by medical device manufacturers including ASTM and ISTA procedures.
- An Analysis of the benefits and drawbacks of certain methodologies and valid alternative solutions.
- Detailed steps that need to be considered when designing your shipper for distribution simulation and a review of the problematic scenarios that may arise during the process.
If you will be in Minneapolis this week for the show, come check out Scott’s presentation and make sure to stop by our booth to say hi.
ASTM Committee Meeting in Prague, Czech Republic
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.
Pack Expo 2009
Here is a glimpse of the TCP Reliable and DDL booth from last week’s Pack Expo 2009 trade show in Las Vegas, Nevada. Scott Levy and Lyndsey Danberry from DDL, David Whitt from TCP and Raj Gill from Cryopak were all there to handle the busy yearly conference.
There was a very diverse crowd of attendees; ranging from food manufacturers looking for temperature controlled packaging solutions for shipping, to pharmaceutical folks looking for cooling solutions to streamline turnaround on time sensitive products. The biggest names in package testing and package design were all there to show off their products and services, as well as enjoy some time in Sin City.
Did you attend Pack Expo 2009?
DDL at PACK EXPO Las Vegas Next Week, Oct. 5-7
We just wanted to let everyone know that DDL will be at PACK EXPO 2009 next week in Las Vegas, Nevada. The event opens up on Monday the 5th and ends on Wednesday the 7th. If you are attending the event, make sure to stop by our booth and meet Scott Levy and Lyndsey Danberry, as well as learn more about what we do at DDL.
We will be one of more than 1,200 companies to showcase the latest developments in packaging technology and state-of-the-art advances in packaging machinery, converting machinery, materials, packages and containers, and components.
Of course, if you have any questions about medical device package testing or other technical packaging questions, we will be happy to answer them for you.
Will you be attending PACK EXPO 2009 in Las Vegas?
Authored by DDL Inc.
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