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.

Our company (Van der Stahl Scientific, Inc.) has attended the MD&M (medical design and manufacturing) west tradeshow for nearly two decades. In fact, this blog is being composed at our booth in the med-pak pavilion. As I watched the steady parade of packaging, manufacturing, and quality engineers file past our booth I cannot help but wonder about the math behind this megalopolis of commerce. In a weak economy it seems almost senseless to send key staff away from their projects as many companies are working on skeleton crews that are barely able to meet the riggers of their demanding time lines. Further, we know first hand the cost to attend these trade shows is absolutely enormous for both exhibitors and attendees. The tradeshow industry seems to work on a completely different monetary system. Rental on a small trashcan is $35.00, which is approximately 10 times its value if you were to purchase this item in the free market. This always reminds me of the military contracts that were audited in the 1980’s showing $1,200.00 toilets and $600.00 hammers. We all need to do much more with much less, it is a tall order indeed, but cost management is a core business requisite if we wish to stay vital.

So how is it that this seemingly antiquated system continues to work? Why do we board planes leaving our families and our desks suffering though airports and aging convention hotels? Perhaps we do it because we simply always have, but should we? In biological and business models alike the cosmos does not favor the lack of agility. Committee thinking with long evaluations and inflexible business practices is death in this lean and mean new cost management environment. After all, how can you help your customer manage their cost if your company lacks a cost management plan?  Although I can still appreciate the value of the tactile experience of a tradeshow, I still wonder whether this tradeshow model will continue into the future. As you can see, on our website we utilize video and computer generated graphics in order to create a more immersed experience with our product offerings. This 3-D modeling allows our customers to look closely at our products from the comfort and cost sensitivity of their own desk. I don’t suspect we will see trade shows completely going away but I do suspect that we will begin to see more consolidation of trade shows in similar industries. And the opposite may happen in other industries where exclusive and narrow trade shows will replace the mega events. I remember in the early 90’s the Comdex shows in Las Vegas swelled to over 100,000 attendees, never would I have expected the Comdex show would ever shrink into its micro segments.

Maybe it is because I am already fatigued from 3 sleepless nights tossing on a slab like bed and eating convention grade stop gap food that my cynical vision is borne. But cynical or not, I am here, and have been for some twenty years. Frankly if I did not come I would feel like a sixteen year old boy missing the prom with nowhere to pin my corsage. So once again here I sit, speaking with my costumers that I have met over the many years in business talking about their products and their packaging challenges. I guess to be totally honest I would miss this human touch. For me, it is a comforting shopkeeper experience that I will be saddened if it completely goes away.

Clearly there are many compelling reasons to use contract packagers, they serve an important role for medical device manufacturers. First and foremost, startups are often ill prepared for the incredible regulatory density that comes along with the sterile device packaging function. After suffering through what I call “regulatory fatigue” brought on by the 510-K process, most medical device startups are unable to get their second wind in order to push once again against the strong tides of sterile device packaging validation and the regulatory process they’re in.

I’ve noticed over the last few years however that there has been a trend from small-to-mid size medical device companies to repatriate the medical device packaging function back into their facility where they can keep it close at hand and create a central point of production and packaging.

As a certified management consultant I would agree there are many compelling reasons to bring this process in house. First and foremost, it greatly helps the strength, and indeed value, of a company when intellectual resources for the technology they create, and use, and ultimately package are captive to the company. If we farm out every function of our company – and many companies do – are we a manufacturer or are we simply a distributor or facilitator? If we choose to create greater depth in the value of our companies, that depth should come from not just capital equipment in house, but also, I would argue, the more important, intellectual human resource, as this creates a holistic company where a spirit of innovation for additional products can take place.

We also have to remember there is often a great deal of time spent managing our outsource contract packagers. Many of our customers told us they were surprised to find when they brought their packaging line in-house, although it was certainly challenging it was very doable. I can tell you having first-hand knowledge as an operation manager at a micro-surgical company, it was very satisfying to see functions from raw material to shipping being engendered under a single roof.

As a certified packaging engineer, I also see this process through the lens of a regulatory specialist. We are, as a company, ultimately responsible for both the good and bad news surrounding compliance. If our company has a packaging recall, ultimately it’s going to be up to us to clean up the mess. And if you’re anything like me, if you’re going to be responsible for process, then you should control the very thing you’re responsible for. And that alone, is probably the most compelling reason to bring your process in-house. Every day your eyes are on the process, you’re creating the system, and therefore when the FDA or any other regulatory agency comes knocking on your door, you’re not blindsided by issues surrounding your packaging process.

Again, I truly believe there are times when contract packaging absolutely makes sense, particularly in the early days when your focus is on your technology and all of the regulatory issues surrounding your 510-K approval, it takes a collaborative team to see your product to market. The helping hand of a knowledgeable third party like a contract packager can truly be an important step in order to begin the siphoning process of your device into the market. But as your company develops through the maturation process, it may be time for you to think about how to create a more whole company with heighten captive capabilities.

When you bring your packaging process in house you create opportunities to save your company money, as the cost recovery tables for the packaging equipment can be quite impressive. And during this era of the lean manufacturing revolution, it is a perfect time to invoke a cost and regulatory control system that will indeed create a stronger more valuable firm.

For nearly 20 years I’ve had the opportunity to speak to literally hundreds of plant managers and packaging engineers regarding their challenges facing throughput, while at the same time staying true to lean manufacturing principals. Many of these medical device companies have opted for the procurement of monolithic packaging machines that have price tags with more zeros than most of our mortgages. The initial costs of these huge packaging machines were often justified through a cost of ownership matrix that promised incredible throughput and minimal downtime. Unfortunately the tales told from the trenches speak of less then miracle machines that spend much of their time in a fatal material jam.

With some of these packaging machines the reliability was so poor, users became close personal friends of factory service agent’s as they became nearly permanent fixtures at their facility. The biggest issue facing this central point of packaging concept is that it creates a single point of failure where all production can come to a screeching halt when the mighty dragon stops breathing.

With a single packaging machine line there is no contingency plan, the only hope of thwarting downtime is centered on preventative maintenance. Unfortunately, when you are looking at equipment that has a parts list that reads like the New York City phone book, thwarting downtime is nearly impossible.

One of the latest manufacturing mindsets I’ve have recently noticed borne from ownership of these mega-machines is what I call the “need to pack syndrome”. When your company invests in machinery, often well into the six figures, management expects to see these machines in motion. When capital equipment of this caliber sits idol, everyone is in a panic. There’s nothing louder than an expensive piece of equipment, silent. The response by production is to run these giant machines, to build up product and to stockpile the warehouse, creating a mountain of finished and packaged product, whereas the sterilization expiration clock is ticking. It is important to remember, motion does not equate to progress. These Jules Verne like machines are captivating even hypnotic to watch the hiss of the pneumatics and spinning rollers lull you into a warm state of mind. These big packaging machines remind me of a 1960’s era Italian sports car, when they are running they are indeed a wonderful machine, sadly much of their time is spent inoperable awaiting a rare part. We are now witnessing it appears a movement to dynamically control the packaging line. The antidote to this big is better fallacy is to purchase five to ten machines at a fraction of the cost of the fully automated system. If a machine does go down or out of calibration throughput does not halt as it might with a single machine line.

Enter the new work cell revolution.
Many of our customers have made the painful decision to divest themselves of these monuments that sits too often idle. They have moved to single operator work cells where management can ebb and flow the per diem employees to finely tune their throughput. This is a concept I have supported for years, as it makes such great sense on so many levels. As a former operation manager and certified management consultant, there are plenty of business and
Management concepts we can hang our hats on when we make the decision to celluarize the process of sterile device packaging.

It’s important to remember that each one of these cellular workstations can produce an impressive amount of throughput. Customers that are packaging medical devices are often surprised to see 10,000 or better parts packaged on a single unit per day and the cost of ownership and the low preventative maintenance schedules are impossible to ignore. So perhaps it’s time to retire you monument machine that’s consuming 1,000 square feet of your production floor and start evaluating how the cellular workstation models can benefit your company. Taking all of your packaging eggs out of a single basket could be a major step forward in the lean and reliable manufacturing doctrine.