Retirement is indeed a wonderful thing.  Although I’m not quite 100% retired, as I’m still consulting up a storm for the AWT mothership a solid 2 or 3 days a month through the end of 2017, most of the time I can sleep in, have a beer or two for lunch, and forget which day of the week it is.  A fine lifestyle that I’ve looked forward to for decades.

The label industry still lurches on however.  With UDI requiring a label with specific and traceable data on it, almost everything in the medical device realm requires a label.  Affixed and legible is still the Holy Grail for packaging labels, a requirement that is often as difficult to pin down as the Holy Grail. On the other hand, hard goods labels (permanent labels on things like controllers, programmers, and other electronic devices that complement the disposables), have very specific requirements which are normally spelled out by quasi-governmental agencies like Underwriters Laboratories.  Back in November of 2009 when retirement was just an elusive dream for me, I wrote a blog post on the UL Mystery. Even with the implementation of UDI, much of the information still applies.

Historically, hard goods labels have been the domain of silk screeners.  They would typically reverse print the graphics on a nice thick piece of polycarbonate (Lexan, if you are one of those people who tell me to make a Xerox, FedEx that package, or blow their nose with a Kleenex), then apply a layer of thick transfer adhesive to the back, and then die-cut it.  This is very durable and works well.

With the UDI requirements, normally a discrete barcode needs to be generated. The most efficient way to do this is to normally thermal transfer printing on the label, which does not work worth a damn on textured polycarbonate. Also, polycarb is typically an indoor film.

Not that a lot of devices get programmed or controlled on a picnic table, but the durability in both temperature and environmental resistance is an attractive feature of polyester, PET…..or Mylar if you are a FedEx / Xerox person.  We normally use a base of clear, white, or silver PET, print your graphics and static information on it, and then laminate it with a thermal transfer receptive PET overlaminate.  It can then be printed with one of the high end resin ribbons, many of which have Automotive Industry Action Group (AIAG) approval for under hood applications.  High heat, gasoline, oil, brake fluid, and antifreeze are typically much nastier than the isopropyl alcohol, cidex, or hydrogen peroxide cleaning compounds used at ambient temperature in a hospital or clinical setting.

The beauty of the system is that everything including the label stock, adhesive, inks, laminates, ribbon, and even the printer in some cases, have been tested and qualified by UL.  Per my ‘09 article, we produce the entire structure, send it along with test panels of the materials that we want the label system qualified on, and a wheelbarrow full of cash to UL labs in Northbrook, IL.  They then send us back the system qualification with approved surfaces, temperature ranges, and indoor and/or indoor-outdoor approval. For those in the regulatory field of medical device companies, this gives the packaging engineer a tested-and-proven set of documentation to pass on to the reg affairs folks and cuts down their testing to a much more manageable level.

Not surprisingly, the team has printed up samples of a number of constructions which can be yours for the low, low price of free!  Just give Blake Insteness a holler and he will drop some in the mail for you to play with.  All we need to know is the surface the label sticks to, operating temperature, and what type of final look you want for the label.

For the surface, keep in mind that it isn’t aluminum if it’s painted. It is whatever paint system is used, something that UL also tests for.  Texture is another really good thing to know.  The more texture, the more adhesive coat weight is needed to ooze into the valleys to form a solid bond.  A number of our device customers have successfully implemented one or more of our UL systems, and we do have a polycarbonate option if you or your marketeers are in love with the ‘velvet Lexan look’.

Good luck.  If you need me I will be somewhere on Lake Superior.

Once again HealthPack, this year in Denver, was a fine way to augment your medical device packaging knowledge, both by listening to the presentations and by hanging out and exchanging info and BS with colleagues, customers, and suppliers. Because of heavy snowfall in the area this year and potential avalanche danger, two intrepid colleagues from an esteemed medical device manufacturer in the Philadelphia area and I decided to head up to the continental divide and make sure that the Healthpack event in Denver was safe from any potential avalanche issues.  After extensively exploring and testing every chute and canyon in the area of the Eisenhower Tunnel on I-70 and analyzing the data at the Westbound & Down Brewpub in Idaho Springs, we determined that the attendees would be safe at the Denver Marriott. A number of them expressed relief that we had undertaken this dangerous and very altruistic task.

The last blog post was centered on ‘affixed’ half of the FDA Subpart 820 mantra of affixed and legible regarding pressure sensitive label stock on terminally sterilized device packages.  Although legibility failure is not nearly as intermittent or puzzling as adhesive failure, it does exist and there do need to be some systems in place to prevent it.  By legibility, we are not talking about using two-point type on a pill bottle to frustrate grandma when she dodders over in her walker to grab the bottle.  A more focused definition of legibility in our industry is to ensure that the information both the label vendor and the device manufacturer print on their label remains in the same readable condition as it is in when the label is applied to the package.  We label printers have a variety of inks including water based, solvent based, and UV cured and a fairly extensive choice of pigment durability to resist UV and fluorescent light degradation. Likewise, we can protect our printing with everything from press varnish to UV varnish to laminates. Typically, the ink system is not specified in engineering prints, but that is slowly changing with the UV / water based split at around 50-50 at this writing.  Device manufacturers have graduated from the old school dot matrix printers and now use thermal transfer printers and laser printers almost exclusively for their variable data.  Both have their advantages and disadvantages, which I discussed a previous blog post.

The main enemy of legibility is abrasion, rubbing or scraping the text, symbols, or graphics off the label. This can come from many sources but the main one is the package itself, typically white SBS shelf cartons, jostling around in a corrugated shipper.  The wear can come from either the corrugated sides or the other cartons in the shipper that aren’t secured tightly enough. The starch in corrugated makes it not only difficult to adhere to at times, but also ramps up the abrasive quality considerably.

Typically, this issue is discovered after distribution when testing either ASTM or ISTA protocols, and can be avoided in a few different ways:

1. The old standby has always been to shrink wrap the package, a solution that has been taking some heat from both the cost and unnecessary waste stream addition angles.
2. In high abrasion situations, perhaps heavy parts like ortho implants (or even several small packages in a shipper), we can spot varnish our printing with a ‘slip’ varnish or UV cured varnish. This protects the flexographic printing that we do on the label and leaves the area to be thermal transfer or laser printed receptive to one of those two processes.
3. We have found out over the years that wax thermal transfer ribbons are usually OK on shrink wrapped packages, but the device manufacturers need to go to the somewhat more expensive wax/resin combo ribbons for extra abrasion resistance.

A few years back, I got a call from a device manufacturer saying that the ribbons we had sold them were “not printing cleanly”. Sure enough, after looking at the shrink wrapped package, the Thermal Transfer Ribbon (TTR) printing appeared to be out of focus, like a person just had a shot of whiskey and a couple beers before looking at it.  After some research, it was discovered that someone in manufacturing had not liked the look of the finished package and kicked up the heat a bit in the shrink tunnel. This caused the wax ribbon to partially melt to the shrink film and as soon as the film moved that out of focus effect occurred. Wax/resin combo ribbons are the best choice for packages with no shrink wrap.

As resin content increases, so does durability up to the point of some pure resin ribbons that have under hood automotive approval on polyester face stocks. We actually have a couple customers that like that combo for their device packages, the main reason being that a certain percentage of their products are autoclaved and that is the bulletproof combo for high temp and high humidity autoclave apps as well as gamma and ETO.  Like most things, it seems to be a balancing act between cost, package aesthetics, and waste stream concerns. Laser printing does not typically have as many abrasion issues because of the natural abrasion resistance of the rough, uncontested paper label surface and the nature of laser toner, which fills those peaks and valleys in the paper sheet and is then fused with heat.

As mentioned above, the qualification and validation activities for legibility are typically visual examination of the package after one or more steps in a distribution testing protocol.  The tried and true standard of standing 18″ away while looking for two seconds with the unaided human eye is usually ignored because people pore over the label, sometimes with magnification, to check for any potential smudging. In the end, however, the definition of legible straight out of Merriam-Webster is, “Capable of being read or deciphered”. Like most labeling-related issues, cost, function, aesthetics, and increased impact on the waste stream are the often competing factors that need to be balanced when choosing components for the labeling system. Good luck!

Photos courtesy of:
http://www.labelskin.com/en/content/4-the-wine-label
http://www.manufacturingtomorrow.com/article/2016/02/three-step-verification-for-lean-product-labeling/7643/

So far, retirement has been everything I have hoped including some trips, some paddling, chasing deer, a bit of volunteer work, and adult beverages whenever the urge strikes. I do have to suck it up and put in about three days a month working in the sticker business, a schedule I kick myself for not implementing years ago.  My most recent gig was attending a supplier mart at one of our customer’s technical conference on the west coast.  The more things change the more they stay the same; adhesion and the lack of it at times are a continuing topic of discussion.

We have all experienced label issues involving the concept of proper adhesion, a.k.a. ‘sticking’.  One end of the spectrum is having the damn things stick when you don’t want them to, like when you buy some cool new gadget and the label comes off in pieces leaving a nasty, gooey residue. On the other end is the label that’s supposed to stick but doesn’t, like the registration sticker on my sea kayak.  Both create extreme suction, to use the politically correct phrase, but both can be dealt with by starting out with a very basic two part question:

What does this thing actually stick to and what happens to it after it’s stuck?

This is an especially critical question for medical device labeling because there are a number of very different surfaces that the label has to adhere to properly and all sorts of nasty things can happen to the label after it is stuck.  When issues occur, people in a number of unrelated areas from manufacturing to regulatory to the end users tend to become both critical and surly.

Adhesion, simply put, is the molecular force of attraction between two different surfaces.  Therefore, knowing the two surfaces and knowing the best adhesive to facilitate that molecular level attraction would seem to be key.  However, that is not always easy.  In the industrial OEM world I don’t know how many times I’ve been told, “Oh yeah, the label sticks to steel”.

Steel has an extremely high dyne level and is one of the easiest things to stick to… with a dozen or so potential pitfalls, of course.

Labels hate sticking to steel that hasn’t been properly degreased.  Lots of times labels hate sticking to steel parts that have been painted and they really, really hate sticking to metals that have been powder coated.  But wait, you say, in those cases they really aren’t sticking to the steel, they are sticking to grease, paint, and powder coating.  Precisely.  A classic label ‘failure’ was at a customer that labeled glass vials.  All of a sudden the labels began to fail which of course meant bad labels and a product rejection.  Upon investigation, we found out that a zealous new buyer discovered he could save a few fractions of a cent per unit by opting out of the ‘flame treating’ process.  He couldn’t figure out how this added any value to the part until his line guys discovered that labels would not stick to the silicone that was typically flamed off at the glass manufacturers. The key, is for us label folks to dig down and find issues like that out before we recommend a label stock.  As the doctors say, prescription without diagnosis is malpractice….which is a great segue into medical device substrate issues.

Tyvek is typically the long pole in the tent when it comes to label adhesion.  Not only does it have an extremely low dyne level, but the caliper of the Tyvek is all over the place.  Simply put, dyne is surface tension.  A dirty car has a high dyne level and when it rains the water runs off.  A newly waxed car has a low dyne level and the water beads up and does not run off or ‘wet out’.  We want adhesive to wet out to help form the bond.  The caliper issue is pretty simple as well.  If you imagine a giant label, it would stick much better to Kansas than Colorado because the adhesive would only bond to the peaks and not get down in the valleys.  So why not add more adhesive like duct tape or Gorilla Tape?  Because the ooze created on the label stock would gum up any thermal transfer printer or laser printer in about 35 seconds, angering the line operators once again (see flame treating above). Tyvek is a well-known and well-researched medical device packaging surface and at this point in adhesive evolution pretty easy to deal with. 

There are, however, many insidious surfaces that want to trip you up.  For us, the most common adhesion issues result from the variety of coatings used on the SBS and corrugated cartons used as outer packaging for the sterile package.  In addition to the pigments and other additives in the inks, a whole new slew of chemistry is introduced when your marketing people decide to make the carton pretty or ‘have the graphics pop’ by adding varnish. Water-based varnish, solvent-based varnish, UV varnish, or the myriad of aqueous coatings, can all add significantly to your adhesion headaches with the outer packaging. By far the simplest solution, one that is 100% effective, is to avoid varnish in the area of your labeling.

This is known in the industry as spot varnishing, where the varnish is printed in specific areas rather than flood coating the entire package surface.

It requires a printing plate up front from the carton printer, but it’s a very low cost option compared to the potential adhesion issues that can arise from variations in the varnishing process and chemistry. With the spot varnish technique, marketing and the end user get that bright shiny package and manufacturing and package engineering and manufacturing avoid costly and time consuming headaches.  Many of the labels that we produce specify varnish coating so we know of which we speak.  Too much solvent, too little solvent, too light of a coating, too heavy of a coating, UV lights that are getting old, or running too fast for 100% curing are only a few of the potential issues.  It is significantly more reliable for adhesive to bond to paper fibers then to smooth, inconsistent coatings.  This reliable bond is especially critical for closure type labels that help end users as well as the restock people at the manufacturer tell if a package has arrived intact.  The most thorough label qualification and validation process will not pick up the variation in lots of varnished cartons, especially since many validations rely on a three lot sample.

Most medical device label sets need to be imprinted at the manufacturers, typically with thermal transfer or laser, with lot numbers, expiration dates, UDI and other data.  These individual labels all adhere to different substrates whether it be pouches, Tyvek, SBS boxes, PETG trays, corrugated, or medical records. If you are really lucky, then adhesion to Tyvek, a known and consistent surface, will be your biggest challenge.  If you are dealing with varnishes, well, good luck!  We will do our best to help and advise as well as control adhesive type, coat weight, and face stock attributes.  What we can’t control are the substrates to which the labels adhere, especially modified ones such as varnished cartons.

There are other anecdotal stories of adhesion issues on device packaging, including the sheet-rocking-next-door-to-the-final-pack-area-dust story, and the even more interesting, pacemaker-carton-in-the-back-of-the-car-window-in-Arizona-in-July. Label bubbling caused by outgassing of certain molded plastic parts that are labelled in a rush before the post-cure cycle is completed is one of my favorites, but I gotta save some of this stuff for future blogs.

If you have questions please get in touch, we have seen most of this stuff before and can help you with that diagnosis that needs to happen before the prescription.

A couple years ago I wrote a blog post on dies, technical and informative but deadly boring. The topic does need some expansion, especially with multiple shapes on a laser sheet label set as well as the intricate back and front cuts on a variety of multiple purpose TTR label sets and closure / tear strips. Not only adhesion and legibility but in the case of closure strips and tear seals the function also needs to be tested. Cutting dies are normally the most expensive part of the one time set up charges and invariably the one with the longest lead time. What I want to do is present a logical progression for simulating die cut parts as well as a method for creating first article and qual / validation parts without breaking the bank.

When a new label is being designed the first question we ask is whether it’s a geometric shape or a special shape. We literally have thousands of standing dies in rectangles, squares, circles, ellipses, and other shapes. Our policy is that those dies are available for use by all customers. Proprietary shapes of course, are limited to the customer that purchased them. Don’t ask to make you some die strikes of that cool tear strip you saw on the Acme Medical Spineatron package, we just ain’t gonna do it. I will make you a die that’s slightly different (if there are no patents involved) and we could do that with one of three methods.

The first method would be wielding the trusty Exacto knife. We can make up some rough cut shapes here or send you the raw material to make your own shape. This has been very successful in evaluating and reducing the number of label options in the mix. A couple things need to be taken into consideration however. If it’s a paper label stock the grain needs to be oriented the same way on the paper that it will be for the actual press run. Paper is much stronger with the grain than it is going against the grain, as we see from the different tear strength numbers for machine direction, MD, and cross direction, CD. It is also critical to note that on complex shapes the Exacto is not quite exacto enough. Small nicks and tears can compromise the shapes. Still it is a very effective way to begin the design and testing phase.

The next logical step is to create some product using a ‘real’ die. The choice here would be flexible or ‘mag’ tooling. We purchase magnetic cylinders of fixed repeat length, the circumference of the die and actual size of the finished label. These tools run from about $275 to $400 and are very good for accurate prototyping and short runs. The cutting is very precise but the die life is much shorter than engraved tooling. Typically we use a larger repeat and put several permutations of the desired shape on the tool, different perfs, shape angles, tear strip configurations, etc. A number of options can be tested for the relatively inexpensive cost of one mag die.

Once the shape is approved we can move to long lasting, precise, and efficient engraved rotary tooling. BUT be advised that if you did your quals and validation on the flexible / mag tooling and want to switch to the production tooling for production runs, more than a few companies regard this as a process change and reams of paperwork, delays, and multiple redundant activities will almost assuredly ensue. Time seems to stand still once these changes are submitted. My advice, learned painfully from years of experience, is to get as far as you based upon your internal change control processes and then buy the damn production tool. It will save lots of time and aggravation for everyone.

When ordering rotary tooling we need to know the material we will be cutting, whether we will be cutting against liner or a steel base roller, estimated run quantity and based on that info which press we want to run it on. Larger presses have a higher hourly rate and take more expensive tooling but can make up for it with the reduced run time from running more parts across on the equipment. The more information we have the better we can dial in on which direction we need to go to get your label qualified, validated, through the FAI process, and into production.

The one certain thing about developing new labels for the medical device market is that you know for before you begin that you are not going to be cut loose to come up with the best, most innovative, cost effective, and unique solution. What we label guys all want is to be handed the saxophone and told to improvise and make some cool jazz. The reality will be more like haiku. We can come up with the best innovative cost effective and unique stuff just as long as it has 17 syllables, three lines, and arranged in the 5-7-5 syllable form. Another analogy would be one of my favorite movie scenes from Butch Cassidy and the Sundance Kid. Newman and Redford are looking for work in Bolivia as payroll guards and are being interviewed by Strother Martin, the boss. When Martin goes to evaluate Redford/Cassidy’s marksmanship he tells him how to stand, how to draw his gun, how he wants him to aim, and of course Redford misses the target miserably. As Strother Martin is turning away disgusted, Redford crouches down, quick draws, and shooting from the hip, hits the target four times in a row. We always hit the target, just not as quickly and accurately as we would if we were ‘turned loose’.

When we get a call to work on a new project the very first thing we do is determine the ‘buts’ in the project. We need a new label that sticks to the nose tiles of the space shuttle, will survive reentry, and be easily removable upon landing – but – it has to have the same size/footprint as our current label. This label needs to provide tamper indicate – but – has to use the same adhesive as our current label to cut down on validation/qual costs. Our label needs to have bombproof resistance to ETO, gamma, and steam – but – needs to use the same cheap, sketchy face stock that we currently use. While it can be frustrating, even us label guys want to be free to riff on new designs and concepts, pre-existing ‘buts’ are a fact of the industry. Just having a device company allocate funds to a label project, usually one of the lower cost items in the package, is gratifying. Once there are a few bucks allocated to pursue a project then the key to successfully completing the project is a thorough triage process to undercover and assess the ‘buts’.

The variables that need to be dealt with are normally the product life cycle, environmental conditions encountered, and the method of demand printing used in manufacturing. The component mix needed to whip up a solution based on these three aspects of the package are the face stock, adhesive, and liner, the inks used, and proper die configurations. Once we get our heads around the entire gamut of the project from the basic design, production, and end usage, including recyclability these days, then we can begin to move forward. With the actual label design that is. Once that is in place then it’s time to run the gauntlet, a gauntlet that seems to add more guys with clubs every year. Package Engineering, Manufacturing Engineering, Regulatory Affairs, Marketing, Quality, and Strategic Sourcing all have a club and will hit your label project with varying degrees of force. In future posts I will try to get more in depth on this increasingly complicated process but for now, everyone have a happy Labor Day.

Image Sources: http://www.metmuseum.org/collection/the-collection-online/search/45434 http://www.heritage-history.com/books/eggleston/great/zpage041.gif

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The continuing trend of corporations to focus almost exclusively on shareholder value, rather than stakeholder value (eg customers, suppliers, employees, etc.), has made the cost of everything an overriding concern.  My theory is that companies that ask for a 5% cost reduction per year are somewhat math impaired because at some point we suppliers would be sending them a stipend for the privilege of doing business with them.  Device companies are getting into the habit of sending out RFP’s, Request For Proposals, and then carefully studying the bottom line of the meticulously returned spreadsheets that are typically submitted 7 or 8 minutes before the prescribed deadline.  Some realize, most don’t, that what appears on the column 6 row 47 entry had very little to do with the actual true cost of the label.  Some companies that generate RFP’s do have a sophisticated system with cost only being one part of the total evaluation of a supplier.  To calculate actual cost of a label, one needs to figure out the many elements of what it costs to get the labeled product to the shipping dock, what I refer to as the Total Applied Cost.  Some of the elements of that are in the graphic above.

My favorite story of Total Applied Cost was not even in the medical field but involved re-manufactured power steering units.  The units themselves were labeled with a high end PET label/resin TTR ribbon combo and moved down the line to the packaging area where another paper TTR label was generated for the shipping carton. Due to a number of reasons, including a line crew for which English was their second language, there were a number of mix ups of the units.  This caused both shade tree mechanics and auto repair shop personnel serious angst when the Chevy power steering unit they were about to install turned out to be for a Ford. The solution to the problem was to triple the cost of their labels.  Both the actual power steering hard goods label and the shipping carton label were made out of PET and printed on one TTR printer with a split liner. That allowed the shipping label to remain adhered to the unit, removed, and applied to the shipping carton as the re-manufactured unit was inserted into the carton.  When this solution was presented to the ‘purchasing agent’, a person whose yearly review was based on cost reduction of her commodities, the quick answer was that no, a tripling of label costs was absolutely not acceptable.  When the proposed solution was presented to the Operations Manager however, he took a look at it, thought about it for about 60 seconds, and asked how long it would take to implement it and whether he could pay a rush charge to get it done more quickly.  Mislabeled power steering units dropped almost to zero once the program was dialed in.  The actual label cost tripled but the cost of failure, including mislabeling that affected both end users and distributors, plus taxed their shipping / receiving department with returns and quick replacement shipping costs, was so great that it dwarfed the label cost increase.

The introduction of labels sets for terminally sterilized device packaging was a similar situation.  When demand printing increased in quality from the early dot matrix six line per inch printers to laser printers and thermal transfer printers, the label set became the commonly accepted method for labeling systems.  Typically the Tyvek lid or pouch label, maybe inner and outer for double sterile barriers, the shelf carton label, a shipper, and a set of patient labels were all on one sheet.  This could easily cost more to produce than the simple individual labels but once you used the Total Applied Cost theory and factored in the one invoice, one shipping doc, one inspection, one check cut, etc., the label set was far and away more economical than the individual parts.  One of the more key things for this system is the quality aspect.  If you have labels left on the sheet something is screwed up. Finally, the line never runs out of that one label that will shut down production, they are all on the one label set.  The administrative, quality, and process interruption aspects are tough to measure and add a dollar value to but almost always exceed any savings realized from purchasing a cheaper label.

As in the power steering example, sometimes more expensive label stock is more cost effective when you look past the labels.  Many device manufacturers shrink wrap their packages, typically SBS outer cartons over a two sided label.  For this set up the typical construction is a lower grade paper sheet and a cheap wax thermal transfer ribbon.  However many of our customers have worked with us and validated a slightly better face sheet with better scuff resistance and brightness and used a wax/resin TTR ribbon to print the variable info.  They were able to pass the package using ASTM 4169 or ISTA protocols and get rid of the shrink wrap.  Did they lower the total applied cost?  When you figure the cost of the shrink film, labor to run the sealer and shrink tunnel, cost of equipment, scrap rate and down time, I think it’s pretty clear that there are a few bucks headed to the bottom line in that situation, not to mention the environmental/sustainability advantages of no more plastic shrink film.

Forward looking companies are able to understand and capture the real cost of their label program and actually move dollars to the bottom line by wisely utilizing that information.  AWT Labels & Packaging can help with that process both through our years of expertise in doing just that as well as tools like a label audit.  That helps pinpoint areas where savings can be realized.

I thought it would be good to get a blog post out before the big event starts in Louisville tomorrow. Packing? Heck, I get that nailed 15 minutes before I leave for the airport. The other thing I need to get done are the slides for my mini presentation at the Standards Update session. Longtime Healthpack sponsor and stalwart, Pat Nolan of DDL, was unavoidably detained this year and I was shanghied by our two illustrious co-chairs, Messer’s Spitzley and Larsen, to say a few words. Very few words. Mr. Spitzley felt that the complete history of the ASTM D 10 group, complete with footnotes, might be an appropriate topic. I believe I will stick to the labeling guidance that our IOPP MDTPC subcommittee is working on as well as a brief update of the Arthroplasty labeling standard that just passed in ASTM F04.

As I’ve written before in this space, current qualification and validation processes for pressure sensitive labeling of terminally sterilized device packages is like a gigantic cafeteria, where heaping plates of every standard or test that exists can be loaded on one’s gray, devoured, and turned into a testing procedure. The goal of this guidance is to offer a more streamlined and usable set of tests and processes to help quantify and satisfy the FDA’s ‘affixed and legible’ requirements in CFR 21, Subpart 820. If we are able to generate a useful guidance and it comes into accepted usage, it is possible that it may be crafted into a standard for testing in one of the ASTM committees. One step at a time however.

Once the label is affixed and legible on the package, we need to turn to the content of that label. Dr. Kent Lowry, in my stompin’ grounds of northern Wisconsin, and his committee have been working on a Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthropasty. After a few years and addressing the negative comments as they popped up, the standard was balloted and passed in F04 at the meeting in December of last year. It is scheduled to be published next month. The basic goal is to identify high priority labeling content and have it in a standard, easy to read format for end users in an OR environment. Like nutritional labeling of consumer food packages, the authors of this standard hope it provides a basis for standardization of labeling content for other implantable devices.

I know many attendees are awaiting Dr. O’s list of dives and micro brewed beer joint like last year’s seminal list for Albuquerque. Unfortunately this year I could not find a truthful and reliable source of information (as the criminal complaint and summons says) to provide such a document. A number of packaging professionals have sent me information gleaned from the internet but I require the personal touch of a friend, relative, or colleague that actually bellied up and plunked down some greenbacks in the establishment. I am confident however, that extensive research will be done, much like the work on the above guidances and standards, and that by Thursday a base of knowledge will have been developed that will guide future visits to the horse racing and baseball bat town on the Ohio River. I’m looking forward to seeing many of you tomorrow.

Once again the English language proves to be a baffling tongue. Depending on context the word die can either mean the singular of dice, the act of ‘taking the dirt nap’, or a complicated cutting tool for making labels. Sometimes I think a rotary cutting die for labels can cause almost as much angst as the other two meanings at times. That may be a bit of an exaggeration because certainly crapping out with big bucks on the table, or an acquaintances extinction cannot be taken lightly. But die issues with pressure sensitive labels are usually the most complicated, costly, and take the longest to fix of any label production issue. There are a few things that can be done however, to avoid the Claymore mine-like effect of things ‘blowing up’ on press with die issues.

The most important thing is to tailor the die, or tool as we refer to it, to the job. Our tooling options at AW range from inexpensive magnetic tooling to really expensive rotary EDM engraved dies on very high Rockwell hardness steel. Both types are in the image to the right. Factors to be considered are what are you cutting, how are you cutting it, and how long do you want to cut it for? A few thousand paper labels, linered and on a roll, would probably point toward inexpensive rotary tooling. On the other end of the spectrum, large runs of Tyvek lidding material, cutting against a hardened steel anvil roll rather than a nice forgiving paper liner, would require bringing out the big, expensive guns. How many cavities a die is built with impacts cost as well. Dies are typically costed with a charge for a blank and a gear based upon circumference and then a dollar per inch of tooling charge based on the grade of steel used. If talking about a simple rectangle, let’s say a 3.0 x (4.0), cavities can be added by building more across or around the web. What he doing with those parentheses around the 4, you ask? I use that to indicate the around the web dimension; it guarantees zero errors. That roll of labels would be 3″ wide and cut every 4″ on the roll. A (2.0) x 4.0 label would be a 4″ wide roll cut every 3″. For a few thousand labels, a one across die would probably be the way to go. For a few million labels, maxing out number across based on press size, eg. 2 across on a 7.5″ press, 3 across on a 10″, and 4 across on a 13″ press would be the way to go. The rule of thumb for number around is that the circumference be greater than the press width. Therefore two 4″ cavities around on the 7.5″, three on the 10″, and four on then 13″ would be prudent.

A couple more elements of die design to consider is how close cutting edges can be and the normal tolerances needed for producing pressure sensitive labels using rotary tooling. If you think of the blade shape, it’s more like a triangle with the sharp edge on the top and a flat base. If you envision this triangle shaped blade it make sense that blades can’t be right up against one another; they should be at least .125″ apart. Tolerances vary depending on the diemaking process and the grade of steel. EDM dies are a bit more accurate than the more conventional CNC dies but both will produce a label die that’s within the +/-.005-.007 range. Frankly, there just aren’t that many pressure sensitive label applications that require that much accuracy. Die to die accuracy (jobs that have more than one die in the press) and print to die tolerance is more typically in the +/-.03″ or .75mm range. Once again this is usually plenty tight for most label applications.

Dies do get dull, with the number of revolutions depending on the answer to the three ‘what’, ‘how’, and ‘how long’ questions listed above. A half million to a million revolutions is not uncommon. When it needs to be resharpened, the cost is roughly 30% of the cost of a new tool. One of the tests we perform is to test the die cut using dye, another aggravating quirk of the English language. We take a red dye and wipe the silicone side of the paper liner and flip it over. If red dye comes through the back side of the liner, it indicates the tool has cut through the silicone and nicked the paper. Another sure visual is when labels start going up with the waste matrix. When we see either of those things it’s time to retool.

This post had been a fairly technical, relatively dry essay, although there is some valuable basic information buried in it. If you really have critical die questions, call, email, or (the best way) stop by the Advanced Web booth at Healthpack in Louisville next month. Not only can you discuss somewhat mundane die issues but you can also race horses! Yes, Churchill Downs and Keeneland have not begun their meet yet but you can gamble on horses at the Advanced Web booth in Louisville. Details and valuable prizes are being firmed up but the vintage battery powered HORSE RACING DERBY game will be at the booth. Certain packaging professionals whom I know will not be allowed to play due to that choking hazard for three year olds mentioned on the box, but most will be green lighted to win, place, or show. Heck we may even need an exacta bet. See you in Louisville!

The year is drawing to a close and the holidays and their accompanying chaos are hard upon us. Whether you celebrate Hanukkah, Christmas, Kwanza, or even Festivus (the holiday for the rest of us), the swirl of additional activity and mega multitasking is inescapable. So rather than some weighty blog post on some obscure labeling topic, and in the holiday spirit of give and take, I thought I’d throw out some valuable business commentary and ask for a little help with definitions in return.

Business terms come and go and after a certain time become as stale as a piece of moldy bread. CBS News recently published a piece called ‘Ten things you should never say at the office‘. I can safely report that at least half of them are in common use at the Advanced Web Intergalactic HQ. We seem to be constantly reaching out to whomever, leveraging our contacts, expertise, or data, and often describe such efforts, when asked to elaborate, by saying it is what it is. We have also had a number of cutting edge solutions which were a great value-add, and we have often circled back to review them and make sure there was no disconnect in the solution. It’s all pure unadulterated crap of course, language that really means nothing and adds nothing of value to any conversation.

A few years back the Harvard Business Review published an article called, ‘The Smart Talk Trap’. It needs to be purchased, Fair Harvard ain’t giving away any content when it can pad its endowment, but it’s worth the read. If you are in a company that drags you into endless meetings where the articulate babble endlessly about solutions rather than actually implementing any of them, you will recognize all the warning signs. If you are the quiet type that would enjoy ‘getting a leg up on’ the people in those meetings that pontificate on anything and everything, the following BS tool is for you.

I’d like to give credit for this priceless gem but all I have is an ancient copy with the three columns on it and no clue where it came from or who gave it to me. I think former Fed chairman Alan Greenspan inspired it with his painfully stilted language whenever he made a public pronouncement. It does work superbly however. Three numbers are picked randomly and you just string the three corresponding words into an official sounding phrase of pure horse manure. For example, I was sitting in a meeting one afternoon a few years back, trying to decide whether knife, gun, or rope would be preferable to sitting through the meetings end. I noticed it was 4:15pm, had my chart, and offered the opinion that, “having our customer service people handle the finished goods inventory task was most certainly a functional organizational concept”. I had a couple blank stares, a couple nodded heads, and suddenly I became the World’s Smartest Man. In that meeting anyhow. Had I waited until 4:20, an auspicious time in its own right, I could have easily dropped functional monitored options into that phrase without changing the meaning, uselessness, or the banality one bit. Try it, I guarantee people will treat you with a new respect plus their reaction will confirm the thesis offered in the Smart Talk article. Have fun!

I would like to get some feedback on a couple terms since I’ve given you, the readers, this priceless meeting phrase tool. As we know, our labels in the medical device industry need to be affixed and legible. In your company or companies that you have worked in, how exactly do they define those terms? With permanent adhesive we have a paper fiber tear test that is performed on every job at Advanced Web. The label is applied to the paper QC folder and there must be either paper tear of the label or fiber tear of the QC folder. That confirms permanent adhesive rather than a removable and is a very objective test. As far as legibility the criteria are a bit more subjective. The EU’s lengthy and descriptively titled guidance, ‘Guideline on the Readability of the Labeling and Package Leaflet of Medicinal Products for Human Use’ very simply states, “The package leaflet should be legible, clear and easy to read in all EEA languages”. UL 969, a test standard for which we have a number of approved label systems here at Advanced Web, describes their test process. Legibility Test – Printing shall be legible. Label surfaces are to be rubbed with thumb or finger back and forth ten times with a downward force of approximately 4 pounds (18 N). Requirement: Printing shall be legible. Perhaps the word legible simply defines itself. Merriam-Webster tells us that the word means, “capable of being read or deciphered”. Maybe this affixed and legible requirement is much, much simpler than we are making it out to be. Does it stick to the package and can we read or decipher it? If so, all is well but we all know and deal with the maze of testing, qualification, and process and regulatory angst has risen around these two simple words.

If you can find it in your hearts this holiday season to email or call me with a brief description of how your current or past places of employment define and verify these two requirements I would be very grateful. Once I compile the information that I’ve received from reaching out to you, I can leverage it and generate a document that will have major value add, be a significant game changer, and perhaps even go viral in the medical device labeling world. Once packaging people have been socialized to use this cutting edge tool, we can circle back to explore possibly getting it accepted as an ASTM guidance. After all, it is what it is. Happy holidays everyone!

Email me at [email protected] or call 612.706.3742. I guarantee it will increase your self esteem.

First of all I apologize for the time between blog posts. I’ve been reminded of this fact a number of times by our Global Marketing Czarina (GMC but not the truck company), a relentless woman that actually threatened me with a device wired to my ignition system some morning if I didn’t get one out. Fortunately, there is no shortage of labeling topics these days, so I thought I would expand on the ‘affixed’ part of the FDA’s ‘affixed and legible’ exacta.

Affixed seems like a fairly black and white concept. Either it’s affixed or it’s lying on the floor of the warehouse. The big question however, is just how affixed is ‘affixed’. From what I’ve seen there really doesn’t seem to be any sort of consensus for just how tightly a label needs to be adhered to a surface. The most common measurement of how well a label sticks to a substrate is peel strength. Peel strength is the measure of the average force to part two bonded materials, for example a label and a shelf carton. Its measured in lbs/inch or gm/cm. Thankfully, I’ve not seen any numbers called out on any prints or specs as yet and I think that’s a very, very good thing. Peel strength, like the porosity and caliper of Tyvek, can and does vary.

The chart below has five different label stocks that have been in common usage for a number of years by five different medical device companies to label terminally sterilized packaging. The peel tests were done on a 90 degree peel apparatus at both 20 minutes and 24 hours. Substrate adhered to was Tyvek 1073B lidding material.

Let’s think about an adhesion spec for a label test or qualification. Remember that all of these face stock/adhesive combinations have been in use on terminally sterilized devices, ETO and gamma, for over a decade. Do we want to have a firm number for a specification, let’s say 1.5 lb/sq”? I would definitely vote no on that. The variation in adhesive coat weight, caliper variation in the substrate itself, and having to inspect, measure, and verify each lot would prompt my negative ballot. Plus given the variation in the chart above, picking a fixed number would preclude a number of adhesives, remembering that all of these are currently functional qualified adhesives for terminally sterilized packaging. If we decided that fiber tear was the criteria then four of the five would be eliminated. In an IOPP survey that was conducted by the Labeling Subcommittee of the Medical Device Tech Committee a couple years back, only 13% of the respondents required fiber tear on any part of the packaging. Pass/fail is definitely the best way to specify label adhesion to the multiple substrates of a device package. So how do we determine the pass/fail criteria?

By far the most common method in current usage is to label the package and put it through its conditioning cycle. 93% of the respondents used ASTM F 1980, accelerated aging, as part of their conditioning cycle. Slightly fewer than 90% then used either ASTM 4169 or ISTA protocols for distribution simulation and then evaluated the labeled package. 87% of respondents just checked the package after the distribution cycle but over a quarter checked at multiple stages in the process.

There are really only three kinds of adhesive ‘failures’ to think about. Removing a label cleanly from a package is not considered a failure; it’s generally referred to as a removable adhesive. Technically if such an adhesive didn’t come off during the supply chain distribution cycle, then it is still indeed affixed. When attempting to break that adhesive/substrate bond we discussed above three things can happen. One is for the label stock to tear and partially remain on the substrate. The second is for the substrate to tear (especially corrugated and SBS cartons), and the last is for co-adhesive separation. This is where some of the adhesive stays on the label and some on the substrate. This is the operant principle behind a Tyvek lid/tray or peel pouch, fracturing of the adhesive itself.

Testing a label for adhesion is a pretty simple, tried and true process. Label the package, subject it to the hot/cold/moisture conditions it may encounter, test for shipping conditions it may encounter and if there is still a label on the package, affixed and legible as they say, you have a winner. The trend of course, is to have more and precise numbers, including peel, shear, and tack characteristics, paper strength numbers for machine and cross direction, and even opacity and brightness numbers. Not necessary people. As I’ve said before, these paper weights and specs can change in two months. Plus the converter, label supplier or device manufacturer can’t even measure them to verify. Even a minor change that results in a new cute name that the marketing gurus like, for example changing Transtherm from 1C to 2C, can result in chaos if we have to send you a C of C that calls out the exact material used. Paper companies can change branding in the time it takes for the average medical device package engineering department to think about thinking about initiating an ECR to document the measly and insignificant change. My advice would be to keep our collective’ eyes on the prize’, affixed and legible.

In just a few weeks the special Olympic edition of this blog will appear. In it we will list the bronze, silver, and gold medal winners of the Head Scratching Label Issue contest. Judges are ready, several potential winners are already in the clubhouse, and names have already been changed to protect the guilty.

Lastly, whoever can name the ‘package’ having its label peeled in the above photo and posts the answer in a comment will be eligible to win a (not!) valuable prize.