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.

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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.

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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.

9. Tyvek Separation Is Not Recognized As a False-Positive
One phenomenon that was discovered some years ago but only really came to light when medical device packages began to be integrity tested routinely using bubble and dye leak methods was ‘sheet separation of the porous web’ of Tyvek.

This ‘sheet separation’ can lead to a false-positive in the integrity test.  The false-positive occurs when the material is bent, folded, or ‘wrinkled’. Dupont has proven that this phenomenon does not change the sterile barrier performance of the material and that any leakage of air or dye solution is only along the transverse direction of the material and not between the Tyvek and poly material, as would be the case in an adhesive (seal) failure.  There is no loss of filtration capability when this occurs.  However, when performing these tests it is incumbent upon the tester to analyze the failure carefully.  In some cases, when there is a suspect ‘false-positive’, it may be necessary to look at it under high magnification to determine the cause of the leakage.

10. Accelerated Aging Is Performed At High Test Temperature
In ill conceived attempts to reduce costs and time, some manufacturers decide to accelerate the shelf life or expiration date studies to unrealistic and indefensible limits.  This is done by raising the test temperature to a level that causes packages to melt-down, warp, or change in other uncharacteristic behaviors.  In addition, temperatures over 65OC are indefensible based on the rationale which is typically used to justify accelerated aging protocols.

Accelerated aging is performed on packaged medical devices to document expiration dates for products.  Real time aging can be performed; however, products are often obsolete by the time a three year expiration date is validated.  FDA does not require expiration dating for products without components with a defined effective life such as batteries.  The European Directives imply that all sterile medical devices must have an expiration date.  Therefore documented evidence must exist to substantiate those claims.

Temperature selection for the accelerated aging study should avoid unrealistic failure conditions such as deformation due to melting.  This advice is sometimes ignored in the haste to bring products to market faster.

If you have experienced other issues with your package validation or package testing, please feel free to share with us what the biggest challenges were.

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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.

2. Cutting too many corners
Most people in manufacturing are unaware of the need to test their packaging, or even that the ISO 11607 standard exists and is used by the FDA and European Community. So they try to validate the packaging “on the cheap” without using sound, scientific practices. In their haste to get a product to market, companies risk non-compliance with regulations, or worse yet, unknowingly let suspect devices reach patients.

The time to properly validate a full-package system depends on the product’s shelf life and its expiration date. For example, it usually takes three to six months to go from package concept to final qualification for a one-year shelf life. The validation schedule should also allow for unexpected events, such as finding pin holes in the packaging after a test. Of course, this halts the validation.

3. The package and product are not pre-qualified for compatibility
A common package-development mistake skips the preliminary evaluation and just dives into package validation. Cutting corners to trim time is short sighted and usually backfires by extending development schedules and increasing over-all validation costs because some part of the package fails. That means retests.

A few common prequalification tests that should be used to detect potential design and manufacturing problems include seal strength and integrity tests on manufactured packages. A seal test, for instance, measures the force needed to open a seal.

Such tests point out potential deficiencies in manufacturing and may indicate the production line needs corrective action. This should be done far in advance of testing package performance, such as for transportation, sterilization, or handling. Prequalification tests should also be the basis for establishing targets for process quality control.

Another test used to prequalify package-product compatibility is dynamic testing associated with transportation and handling. A shaker table reproduces the frequencies and amplitudes the shipping container is likely to experience and for a prescribed duration.

Most sterile medical-device packages do not typically lose sterility simply sitting on a shelf. Failures often stem from events in manufacturing, during shipping to the sterilization facility, or during distribution. Therefore, proposed packages should always undergo a prequalification to isolate potential hazards and determine the package response to each of those hazards.

4. Ignoring the worst-case scenario
It’s often difficult to determine which shipping configuration to validate. Should you test just one product in one package? Or four products in a box?

To determine the worst-case scenario, it is necessary to determine the most common shipping configuration before validating the package. In this way, other package configurations of the same or similar products may be covered by one validation.

A few ISO 11607 guidelines work to device manufacturers’ benefit. For example, a provision allows validating families of packaged products rather than individual configurations.

5. No time to develop protocols
Before working on a validation, write a protocol. It provides a blueprint for how testing will be done, including its purpose, scope, responsibilities, parameters, production equipment and settings, and acceptance test criteria.

Validation qualifies the materials and processes that make the complete package. If one process is not right, the entire system breaks down and the manufacturer risks harm to patients.

Have you made any of these mistakes when developing and validating your packaging system?

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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 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 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.

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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.

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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.

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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.

Standard Test Method F1929, the most widely used test method for package seal integrity, is in the process of being modified to include new test methods. Two alternative methods are in development for evaluating the seals of packages using dye solutions that seek out channels in seals through capillary forces. The first new method, known as the “Dip” method, is performed by dipping the outside edge of the package in a tray or container of dye solution. If any channels are present along the seal, the dye will migrate into the channel from the outside through capillary actions. The second method under development is the “Eye Dropper” method. This method uses an eye dropper or syringe to apply the dye to seals between the ‘seal allowance’ or excess material. The channel, if present, is manifest in the same way as all other methods, that being through capillary action. The procedures have been developed and written into the current F1929 standard. A vote for approval is eminent and a successful vote will prompt the start of a interlaboratory study (ILS) to determine the Precision & Bias (P&B) of the methods. It is anticipated that this process will require about 12 months. Contact Geoff Pavey for more details or to participate in the ILS.

A new standard for dye penetration is also being developed for testing the seal integrity of non-porous packages. The theory of the method is the same as F1929 except that, due to the nature of the materials used for non-porous packages, a different dye solution is required to manifest the seal channel leaks. Method A will be an injection method, as in the current F1929 standard. The dye solution will have a higher concentration of surfactant to reduce the surface tension of the liquid to allow for capillary action to occur. A second method is being developed to evaluate the surface of the package components. In this method the components will be separated so that flat sheets can be laid on a white absorbent medium. Next, the dye solution is applied to the surface using a dye soaked sponge. If material breaches are present in the material, it will be apparent by the white medium under the package material being stained by the dye. The test standard is being written and an ILS is in the planning stages.

Another activity for a new standard, involving a method for evaluating the quality of seals in plastic cups with heat sealed lids, is in the ballot process. This method measures the force required to peal a lid from a container. The method has been balloted once and received many good comments. A second ballot will occur before an ILS is developed to determine the P&B of the method.

An activity to develop a practice for subjecting packaging systems to environmental stressing is also occurring within subcommittee F2.50. This method is being developed to provide a standardized practice using environmental conditions that are extreme but realistic. The first draft of the standard has been voted at subcommittee level, but there is much work to be done including coming to a consensus on the temperature and humidity conditions to use for stressing packages.

Lastly, the F2 Committee hosted a workshop for the European contingent with the objectives of demonstrating the ASTM process of standards development and to provide technical information of some highly successful ASTM F2 standards, such as F88 for seal strength testing. The workshop was very successful as about 20 European packaging professional attended the two day event. Participants learned about the importance of validating test methods through r&R studies, the ASTM structure and framework for developing consensus standards, climatic conditions effecting packaging, and dye penetration seal integrity testing methods.

Committee F2 looks forward to the next opportunity to host a meeting at an international venue, as this meeting was deemed to be very successful in meeting the objectives of ASTM and the committee was able to be very efficient at carrying on the work of the Committee.

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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?

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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?

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