Thirty-seven years ago a knowledgeable group of people created the standard for flexible package seal strength testing. The F88, created by the F02 committee on flexible barrier materials of the American Society for Testing and Materials (ASTM), created the standard to determine the seal strength of flexible barrier materials.

Today, millions of seal-strength measurements are used to qualify materials for physical package testing. Over time, ASTM F88 has undergone many revisions. But the original three-page document has remained the foundation of today’s standards.

In 2000, members of subcommittees F02.3 on food and consumer packaging and F02.6 on medical device packaging worked together to address conflicting data issues found when laboratories use different techniques in their testing. Members of the Sterilization Packaging Manufacturers Council (SPMC) Technical Group volunteered to design a new protocol, produce laboratory samples, coordinate the labs and analyze data for a new statement that would encompass the many modifications made to the original document over the years.

Members of this group came from many businesses, including Amcor Flexibles, Beacon Converters, Oliver Products, Perfecseal, Rollprint Packaging Products and Tolas Health Care Packaging. There were also participating volunteers from Cryovac, DBI, Inc., Distribution Dynamics Labs, Inc., Eastman Kodak Co., Edwards Life Sciences, Kraft Foods, Inc., Michigan State School of Packaging and Vinatoru Enterprises.

An Interlaboratory Study (ILS) approach was used to define repeatability – the amount of variation when samples are tested in the same lab, with the same operator, using the same equipment in a same day setting. ILS studies the amount of variation found between those labs.

The SPMC group studied more than 2,000 seals in a testing protocol that was designed to comprise three independent round-robin test series. All testing was based on use of peelable seals.

Test series A evaluated a coated paper and film combination for differences in speed of crosshead travel and for two different techniques of tail peel angles. Series B took an uncoated material with the 1073B Tyvek/film combination and kept the crosshead speed consistent while again varying the control of the tail angle of peel.

An addition test was performed using reverse direction in order to demonstrate what occurs when less flexible material is bent back, while more flexible material is supported by the backing plate.

Test C took a sealant material common to the two substrates of different caliper and sealed them face-to-face to measure the effect of a change in flexibility to the measured value.
Results of the testing demonstrated a significant difference in results depending on how the tail is oriented – the grand average of seal strength changed with each technique of handling the tail of the seal – and a change in flexibility was noted when tested supported or unsupported.

This knowledge was noted and is now part of the F88 standard.

The round robin approach taken by SPMC produced the necessary common knowledge that allows today’s testers to feel confident that their data reports will now agree with data from other labs, creating a more stable, dependable results standard.

A truly thorough understanding of ISO 11607 is needed to ensure product efficacy and ultimately, patient safety. And yet, everyday medical device packagers face failures and even product recalls.

So, let’s take a look at the four basic aspects of sterile barrier system expiration dating.

• Relevant definitions
• Performance testing vs. stability evaluation
• Real time vs. accelerated aging
• Suggestions for expiration dating evaluations

A package stability evaluation demonstrates the sterile barrier system maintains integrity over time. So when we say the term “package stability/expiration,” we’re referring to the date the product should be used.

There is a difference between “performance testing” and “stability evaluation.” Performance testing evaluates the interaction between a packaging system and the product in response to the stresses imposed by the manufacturing, sterilization, handling, storage and shipping processes and environment. Whereas, stability evaluation demonstrates a package system’s ability to maintain an acceptable level of its critical characteristics after exposure to specified sterilization cycles and time. Stable testing is usually part of an overall packaging validation program.

When looking at real time vs. accelerated aging, remember that aging should be done using a real-time method. Accelerated again data is acceptable as long as it’s started in parallel with real-time testing sequences. As stated in the ISO 11607 standard, stability testing via accelerated aging protocols will be considered sufficient evidence for claimed expiration dates only until data from real-time aging studies are available.

When evaluating expiration dating evaluations, consideration should be given to worst-case as specified for sterilization cycles, as well as the number of exposures possible in the everyday production environment.

The topic of package/material stability evaluation has generated some great debates and articles from industry leaders. Watch the news wire for more updates on this sometimes tough topic.

Last week one of the most innovative creators of our time died. Steve Jobs’ passing was a sad instance of an amazing life cut short, yet again by that dark disease: cancer.

His death came a day after the FDA Commissioner released a set of suggested steps that can be taken to drive biomedical innovation. Jobs had a profound effect on the consumer electronics industry. But his amazing innovations reached far beyond gadgets for listening to music or tablet computers.

These innovations changed the ways in which we communicate, how products look and feel, and the manner in which we find and share information. He also made pioneering changes in the medical device industry.

Jobs’ innovations appear in the growing use of iPads and tablets in the clinical environment. In addition, Apple products such as the iPhonehave been instrumental in fueling the growth of the exciting such as mobile health and telehealth.

After his passing web publications MPMN and Qmed have covered many of the ways Apple technologies are being used in the medical device industry and their impact on the market.

Qmed published the article, “The iPad Touches Medical Device Design”, pointing out that a growing number of design and technology companies are helping medical device manufacturers incorporate a similar look and feel of the iPad into their products.

Qmed also published the article, “Researchers Transform iPhone into High-quality Medical Imaging Device”, which spotlighted a team of researchers from the University of California, Davis, who have transformed everyday iPhones into medical-quality imaging and chemical detection devices. These decked-out smartphones are used to perform detailed microscopy and spectroscopy. The team who created these devices will present their findings at the Optical Society’s (OSA) Annual Meeting, Frontiers in Optice (FiO), taking place in San Jose, Caif. On Oct. 16-20.

Another article published in Qmed recently was “Mobile Skin Cancer Screening With iPhone handyscope Dermascope from FotoFinder“, which talks about the “handyscope,” the first mobile skin cancer examinations for the iPhone. The digital handheld dermatoscope allows doctors to capture and save microscopic pictures of moles. The handyscope device is attached to the iPhone and put directly on the patients’ skin, allowing high resolution mole images to be made, with up to twenty-fold magnification.

Steven Jobs’ innovative passion will be sorely missed, but even after his death, the effects of his innovations will continue to grow and reach millions as they evolve in new, creative ways.

For those of you that follow Van der Stahl Scientific’s packaging blog you may remember a while back, I wrote a blog about bells and whistles. When I penned that last blog, my hope was that the marketing department would leave engineering alone in our industry and that machine manufacturers would focus in on only usable machine attributes and not bells and whistles. But alas, it seems that I was wrong. In fact, it seems like the trend has gained some momentum and more companies are moving toward touch screen displays and proprietary functions that are designed to create an oooh and aaahhh factor at trade shows. Now, don’t get me wrong. As I’ve mentioned before, I love technology that is thick with features. I’m a ham radio operator and can comfortably sit in my easy chair and read a technical manual cover to cover. I gain great joy in learning about features of my latest electronic gadget. But this isn’t an iPad or an all-band amateur radio. It’s a medical packaging machine and it’s regulated by jaundiced third parties.

When we create too much complexity in machinery with the initial goal of simplicity, we end up with so much data scatter it is impossible to manage, and  it is extremely difficult for a third party to interpret. Further, as I had mentioned in an earlier blog, “Don’t Ask a Barber if You Need a Haircut,” you must be careful about gaining confidence in a machinery by asking a machine if it performing as expected, think HAL in 2001 A Space Odyssey. As Ronald Reagan said, “Trust but Verify.” Or as the Texans like to say, “Trust your neighbor, but brand your cattle.”

We have simply focus away from the spirt of validation and the scientific method for that mater when we try to integrate validation within a machine itself. The machine must be compliant to 11607, and every machine that we offer to the medical device manufacturing community meets those robust rigors of the FDA and the ISO 11607.

Our company has taken a very different approach to determining if a machine is working as expected and it’s all centered around whether or not the seal is strong. We don’t ask the customers to believe we’ve created a compliant seal. We believe the customers need to verify that the machine has created a compliant seal. This isn’t marketing, it’s the law. This is why we have sealers that integrate peel testing on the sealer it self, as it is output data that makes or breaks your validation.

So, perhaps the next time you’re perusing a medical packaging trade show, you should think carefully about machines that provide on-board validation ports and features. If you’re hanging your validation on a manufacturer’s proprietary features of the machinery, you’re asking for trouble.

As a certified packaging engineer and certified management consultant that’s had the great fortune to speak with thousands of quality teams over the last two decades, I can tell you that it’s the validation you create through processes and simple and sound science that’s going to keep you from squirming in your seat during an audit … not a packaging machine manufacturer’s bells and whistles.

Your packaging machine is merely a soldier in your sterile device and sterile barrier system battle. It’s not a general or even a sergeant. It’s a simple infantryman that needs to be guided through your skilled hands. And as I tell every single quality group I speak with, if you really want to get serious about your medical packaging program, test your packages regularly. That’s by far the single most important piece of advice on the road to sterile device packaging compliance.

I am one of the most thorough people I know. Some may say a little anal retentive. When I leave my desk at night, everything is put away. And my lucky, trusty Green Cross pen is set at a 45 degree angle on a clean, white piece of paper. But I’m perfect for my job. After all we’re in an industry of details. The little things matter. I spend a great deal of my time checking and re-checking all the functions of my day-to-day tasks. It’s been said God is in the details, and I believe that’s true. In a time of so much rounding, it’s refreshing to be in our industry where everything is important. I just wish the whole world shared my monomaniacal vision of accuracy. From the orders at the restaurants I’ve sent back three times because everyone from the server to the cook could not be burdened with the accuracy of the job at hand, to the automotive mechanic that forgot to torque the drain plug on your oil pan, causing your engine to seize; rounding has become a plague.

I mean, I am absolutely astonished by how it is we have come this far, but still pounder the future if we do not add a bit more care in our daily functions. Every time I hear the Six Sigma term, I can’t help but laugh. Minuscule failure requirements are a joke. Ninety percent of my daily interactions with companies are a fail. Sorry I didn’t mean to get into a rant, but I’m sure you can relate to the new storm of inaccuracy.

But still we must be careful of the other side of the equation. Under our thick regulatory environment it’s easy to bog down to micro details and when we over-shoot the mark on the other side of the equation, we make it impossible for others to interpret our work.

If the bottle says “two pills every four hours,” taking 10 will have a bad outcome, just as taking one would have a bad outcome. Where we need to be is where we need to be, not less, not more.

Engineers, and I know I’m guilty of this myself, tend to major in minors. We tend to look through such a high resolution lens that we have a hard time seeing the entire scope of the project. We also lose sight of the fact that someone at some point is going to have to interpret our work, and if it’s too dense it’ll be impossible to interpret and to implement. I had a customer ask me last year to provide him a detailed multi-page report on the metallurgy of our base plate. This information was needed for the IQ he was engendering for his sterile device packaging validation.

Trying to understand the gravitational mass of your machine has will never be asked by an auditor and isn’t relevant to the total scope of your validation. If we get bogged down in our DOE work, we expand the numbers out so far until we create an outlier. If the outlier is statistically irrelevant, all we’ve done is work to find a problem that ultimately will not impact our process.

Thoreau said, “Work for progress, not perfection. I’m not sure I’d go that far. I guess my modified vision is: “Work for progress, while striving for perfection.

Steven Jobs famously said once when he was frustrated with the slow release of a product because the engineers were so bogged down trying to create perfection or as they referred to it as “art,” he simply replied, “Art ships.”

At one point the big rollup door at the back of our building has to send out products to pay our wages. We have to stay focused on the fact that we’re in manufacturing and products must go for the economic circle of life to continue. So go ahead, focus on perfection. Don’t waiver on details. But remember that a skilled engineer can meet both the mandate of quality and throughput.

Much of the medical device industry has been slow to incorporate biodegradable, green materials in their design for several reasons, some of which include cost and regulatory concerns.

But there are eco-friendly packaging options out there and the trend is picking up speed. According to BBC research, the biodegradable plastics market had reached more than 500 million pounds by 2007 and should reach 1.2 billion pounds by 2012.

One bio example currently in use is polylactic acid (PLA), which accounted for nearly 90 percent of bioplastics used in 2008, according to a study from the Freedonia Group. PLA is made from starches such as corn or sugar. And resin manufacturer Cereplast is utilizing hybrid plastic resins made of up to 50 percent green content, such as corn, potatoes and rice.

Another green option for medical packaging suppliers is recycling. Recycled polyethylene terephthalate (RPET) can be used in secondary medical packaging applications.

A few years back, Placon launched an EcoStar PET family of products that are made up of at least 50 percent post-consumer content and 85 percent total recycled content. The products included clamshells, in-process trays and glucose meter packaging.

More recently, big-names Kimberly-Clark, Johnson & Johnson and Waste Management are among a group of companies that have founded a technical coalition to develop recycling and packaging innovations for medical products. Healthcare Plastics Recycling Council also includes DuPont, Cardinal Health, Hospira, Engineered Plastics, and Becton, Dickinson and Company.

The group seeks to increase recycling of healthcare plastics and identify barriers and solutions that exist along the entire product chain, from design and manufacturing to use and disposal.

The group formed in April, 2011 and is first focusing on three initiatives that will focus on identifying the issues and barriers that prevent plastics recycling; developing a document that will outline product and packaging design considerations that could up recycling in the industry; and a series of pilot programs within healthcare facilities that could provide data to enhance recycling abilities.

The bottom line is a focus on green medical packaging is on the rise, and companies should begin internal evaluations as to how they can stay abreast of the trend.

Source:
http://www.environmentalleader.com/2010/03/12/suppliers-push-medical-oems-toward-eco-friendly-plastics/

http://www.environmentalleader.com/2011/04/06/johnson-johnson-wm-six-others-start-medical-recycling-coalition/

Validation compliance, real-time data and sustainability are among some of the top concerns for medical packagers in the current market.

Medical equipment makers, as well as pharmaceutical companies are dependent on medical packaging machinery builders to satisfy all validation compliance matters. So medical pouch sealing equipment must adhere to the highest standards.

Equipment like that found at Van der Stahl Scientific does just that with data capabilities that are embedded within the machinery, which makes the user’s regulatory compliance much simpler. Equipment should also include quality maintenance options and a visual inspection processes for solid, real-time data.

As mentioned in “Green Packaging Trends,” many package designers are also “going green,” adhering to an increasing demand for more recycling and biodegradable materials in the product lines.

Sustainable packaging has seen incredible growth in recent years and is still on the rise, as a recent report from Global Industry Analysts, Inc., “Sustainable (Green) Packaging: A Global Strategic Business Report” is predicting the market will reach $142.42 billion by 2015.

Government initiatives working to decrease environmental hazards related to packaging disposal, including greenhouse gas emissions, with stringent regulations, are driving the growth of the sustainable packaging market.

In fact, sustainable packaging showed impressive growth during 2008-2009, a time when most other segments of the packaging industry were stagnant, or actively declining. So green packaging may just be immune to the current economic downturn.

So far, the report shows Europe and the U.S. represent the largest regions growing in green packaging, accounting for more than 70 percent of the world market.

Sources:
http://www.healthcarepackaging.com/archives/2010/08/market_research_delivers_packa.php

http://www.packworld.com/article-30274

Recently I attended the medical design and manufacturing west trade show that is held each year in Anaheim California. I had the opportunity to evaluate and inspect manufacturing machinery from hundreds of companies that show at this mega-show each year. Our company, Van der Stahl Scientific, has been showing at this trade show for nearly twenty years. It is a great opportunity for us to show our line of medical packaging machinery and also to showcase machinery in progress to get manufacturing engineer’s feedback of our new technology. There is no question that I have seen more innovation from manufacturing companies this year. It does my heart proud as an American to see that we have, for the most part, resisted the “sell cheap” model of business and we are still setting world standards on technology.

When I travel abroad to Europe and Asia, I always beam with pride when I see the operating systems on every company’s computer I visit is either Microsoft or Apple, because this indeed is the future for Americans. Our brain trust has engendered incredible technologies that serve the world in a variety of industries. My identical twin brother is the author of The Innovation Playbook. My brothers book chronicles incredible success stories from the nations leading innovators. Innovation can be a difficult mindset for companies to adopt, as many seem to focus on the price sensitivity of our weak market. They forget to develop products based on total value. Like most consumers of both industrial and consumer products my goal isn’t to buy cheap, my goal is to find value, and there is no better way to create value then to innovate. It has become a tired tale of American products jumping across the Pacific for better pricing. We all need to remember it is a world market and frankly where a product is made is far less important than where a product is innovated. Consider the Iphone, which by the way I consider  to be the most amazing technology of our time and is indeed ground zero of the American technological zeitgeist, is in fact, made in China. This is the time of what it does not where it is made. Due to a host of political issues that we are not going to change anytime soon, sometimes outsourcing manufacturing abroad, just simply makes sense. As a certified management consultant I cannot simply advise clients to make their product under a heavily unionized system, slap an American Flag on the product and expect it to be the selling point. The question you need to ask yourself is “Where is the value in my product?” and that value typically comes from feature benefits that create a better consumer experience. And again it is through the creative mind trust of the U.S. where amazing products can be developed. We need to think our way into a better company, retire the red pen and look at new ways to develop a better user experience for all the products we offer to our customers.