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 dolson@advancedweb.com or call 612.706.3742. I guarantee it will increase your self esteem.

Lately I've received an increasing number of new and 'critical' label tests and requirements that we need to deal with. As we all know, in terms of device cost percentage and engineering time and energy spent, the label is the proverbial flea on the dogs' tail. Yet the label is still a critical component that needs to remain 'affixed and legible', as a well respected government agency puts it. To that end, more tests and standards have sprung up to make sure that those two simple criteria have been met. In this post I'd like to examine a select few of those tests, figure out if they actually provide any value as far as a label remaining affixed and legible on a terminally sterilized device package, and then make fun of a few that I think we all can agree border on the ridiculous.

In order to get a bit more ammo for the latter of the three blog post goals, I sent out an email to a few engineers and others that I've actually discussed the topic with over the years. I asked for, "….a bit more label testing stupidity than I have at hand so I can award an Olympics-like gold, silver, and bronze in the blog post. Plus, it will be kinda fun and a bit of needed catharsis for us all". Not surprisingly, the response to this email could be described as a few levels above 'brisk'. Both the number and promptness of the responses after I sent the email would lead me to believe that there is a bit of frustration among the package engineering community about the efforts needed to confirm 'affixed and legible'. Some of these tests are not exclusively for medical device applications and a couple wander from pure label testing, but they are fun anyhow. Thanks to all who submitted them.

These test puzzlers fall into three broad categories. ''If X is good then 2X must be better', 'if it worked for the apples it must work for the oranges', and 'it must be 3.684 +/-.001'. A rub test for a paper label in a OTC environment had been set up at 200 rubs (Sutherland tester) with a 2# weight. Someone in the company decided that if that was good, a much better and more robust test would be 1000 rubs with the 4# weight. Would a package ever encounter that? Would it even be subjected to 200 rubs with two pounds of weight? The best part of this was that water was not enough; a second test of 1000 rubs at 4#'s with Coca Cola was performed as well. I wonder if the test would have been invalid had Pepsi or RC Cola been used? We will never know I guess. Finally, would a conditioning cycle like ASTM 4169 be enough to ensure that this package made it from the Acme Pharma plant to the store shelf? I'm going to go out on a limb and say chances were probably greater than 95% that it would. Yet five respondents to my little email note said that someone in their organization did not feel that the 24" drop in ASTM 4169 was 'robust' enough, even with the 48" bottom drop added on at the end of the sequence. Once again if X (24") is not good enough, then 2X (48" on all sides) must be better. One quick thought that was expressed regarding ASTM 4169; if the label passes that conditioning cycle, why bother to initiate more stand alone tests? That same 'double x-ing' goes for temps on accelerated aging tests and dosages of ETO or radiation in sterilization cycles. One respondent remarked that he loved the 'triple gamma' test. "You turn your plastics into dust but damnit, the label is still legible".

The 'if it's OK for apples, it must be for oranges' test that several people commented on was the venerable pouring of water on a paper label, letting it sit for one minute, and then wiping it off. That particular test is straight out of BS EN 45502 for active implantable devices. One quick observation: if you make ortho implants, stents, catheters, etc., why are you using the active implantable standard? The main subjective flaw that I've witnessed in this test is the line, "rubbed by hand, without undue pressure". I recall my mother grabbing me, a dirty faced kid, and attempting to clean my face using the end of a handkerchief and 'mom spit'. I'm sure she felt that the pressure was not undue but to a little kid it felt like she was using 80 grit wet/dry sandpaper as I tried to escape her headlock. My guess is that if my mom were performing this test nothing would pass. In my humble opinion the above mentioned Sutherland Rub test is much more objective and accurate if you really need to perform the test. The other issue is that you are pouring water on paper. It always leaves a watermark. If you peruse ISO 11607, the definitive guide to terminally sterilized package testing, you will find the following: 6.2.2.2 - Opened package samples shall be inspected for defects such as: d) the presence of unacceptable humidity, moisture, or staining. Soooo…..if you developed a label that survives the water test and it actually gets exposed to water and stained, would it pass this ISO 11607 criteria? I don't have the answer to that. If you really feel you need to pass this test with flying colors, just switch from paper to white polypropylene, BOPP as it's called. It will ratchet your cost up several levels but if this is indeed a critical part of your package evaluation, cost is no object, right?

Finally the 'it must be 3.684 +/-.001 type of test. In the good old days we used to get prints generated by mechanical engineers with the same tolerances as a piece of machined steel. They did not know our process capability and, frankly, neither did we. The saving grace was that they really didn't measure it after the FAI anyway or didn't use a high tech, calibrated tool anyhow. Things have gotten a lot more precise and controlled since then, but in many cases involving package testing it is much more sensible to have the criteria set up as pass/fail rather than attached to a certain precise value. One personal experience with this issue was not a label but the Tyvek lid that it was affixed to. We produce Tyvek lids, printed and unprinted, at Advanced Web and have since the late '70's. There was a merger/acquisition and suddenly one of our customers was a small cog in a big machine that had much more 'robust' quality standards. The large company had a maximum porosity reading of 130 seconds in their inspection procedure for Tyvek lids. Absolute max,c=0, period. All of a sudden, after a perfect quality 100% record for three years, we started getting lots of Tyvek lids, perfectly functional Tyvek lids, rejected and held hostage in quality hold. The problem was the c=0 thing rather than the average of several readings, either on one lid or on the sample. If you look at the image of a Tyvek lid (above) you can see the thickness difference, the 'ropes and veins' of the varying caliper of the Tyvek. I would like to bet anyone a case of microbrewed beer right now, that if you stuck that Gurley meter right on the dark spot in the top center of the image, the reading would be in excess of 130 seconds. Summit Extra Pale Ale, please. Of course it's a useless requirement because the ETO gas will flow to the lighter, thinner spots and sterilize the device. If the entire lid is not porus enough, our guess was that the seal would blow. A noted Dupont technical person, since retired, agreed with our assessment and after a process that was more painful and drawn out than a presidential election campaign, the inspection criteria at MegaMedical was changed to a more realistic and useful process.

I have one more test, a test that defies categorization in any of the three I've outlined. I will have to give it the Gold Medal. This story also requires you to paint a mental picture of this test in progress. A group of company managers and directors are standing in a conference room and throwing pouched trays holding 100cm Guide Catheter against a wall to see if the snap fit on the tray worked to hold the device. I'm sure it was not described and codified in any official company test protocol and I would hope the label held up under the wall impact. My guess is that no ASTM standard will be balloted any time soon for that test. A similar test was for a device packaged in a polypropylene box that failed the "sit in the rear window of the sales guys locked car in Arizona in June" testing protocol. We actually addressed that one and found a suitable adhesive but that's another story.

That is indeed the bottom line after all. If you have a test protocol and share it with us, we will do our damndest to come up with a label that works. Adhere to the nose tiles of the space shuttle, survive re-entry, and be easily removable upon landing? Let us give it a shot. However sensible testing and qualification protocols, based on peer reviewed and industry approved standards such as ASTM, ISTA, TAPPI, and ISO standard to name a few, are really the way to go. Dr. Mike Scholla of DuPont Protection Technologies pointed out at an ISO Technical Committee meeting a couple years back that "it is OK to use non-standardized test methods, but if you do you may have to show how it compares to the standard method. And since you have to do that work anyway, why not use a standardized test method if you can?" You don't need to go rabbit hunting with an elephant gun and the word on the street is that cost reduction is the mantra in many device companies these days. There are a number of ladies and gentlemen in the tough environment of Barcelona Spain, as you read this, toiling away diligently on developing and fine tuning various ASTM standards. As well as some possible wine testing. As I pointed out in a previous post, it's time to come up with a unified guidance on testing the labeling for terminally sterilized devices. We need to have a series of tests that will reliably predict that labels will remain 'affixed and legible' to meet FDA standards. Email me please; let's see if we can get something moving forward on this continuing issue. I get a real sense that we have the resources; we just need to pull them together.

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.

Healthpack 2012 in sunny Albuquerque, NM is in the books. The two winners in the informal brewpub and dive diners competition were both exceptional. The beer winner was a dead heat between the Elevated IPA and the Square Root of Elevated Bitter from La Cumbre. Both were not only exceptional ales but both were available pushed (regular CO2 tap) and hand drawn on cask. This of course, required four pints for proper evaluation, a mission I chose to accept gladly. The dive diner winner was the Frontier Restaurant, right across Central Ave from the University of New Mexico. The quick, cheap, homemade enchiladas and other southwest chow was flavorful and authentic. People allegeldy drive hours, all the way from Colorado, for their green chili. There was some whimpering about no beer at the Frontier but that situation was quickly rectified after dining. A good time was had by all in Albuquerque judging by all the bright eyes and smiling faces on Thursday morning.

In addition to beer and dining, some useful packaging trend and initiatives were discussed at Healthpack as well. I am biased since I chair the Labeling Subcommittee of IOPP's Medical Device Technical Packaging Committee, but our group session was very well attended and we discussed some pertinent current labeling changes that are in the works. There is a major joint implant label standard that's in ASTM balloting, E Labeling is a whisker away from approval in the EU, and UDI is aging like a fine vintage wine in the Office of Management and Budget after being sent there last July by the FDA. Actually on 20 March a bi-partisan sponsored bill was introduced in the Senate to require the FDA to issue a final rule on the UDI guidance by the end of the year. The other discussion the group had, one that seemed to pique everyone's interest, was on creating a guidance document for testing pressure sensitive labels on terminally sterilized device packages.

The Labeling Committee did a poll two years ago to attempt to baseline what device companies were doing to qualify and validate their labeling systems. The result showed a bit of the 'snowflake effect'. In other words, no two companies were alike. Reading the results reminded me of a dozen people walking through a cafeteria line. Everyone takes different items from the dozens being offered, based upon likes, dislikes, and past experience, and most people seem to be reasonably happy with their selections when they chowed down. Right now there are a pile of standards from anyone and everyone regarding labels. Companies seem to pick the ones they like and the ones that address issues they have had in the past, and then etch them in stone for future label testing. This makes changes very difficult and there is no commonly accepted standard on testing and confirming adhesion over time and print durability.

The FDA and other international agencies on the other hand, are fairly clear on what they want to see with device labeling. Good ol' CFR 21, Part 820, Subchapter A, Part 11, Subpart K reads, "Labels shall be printed and applied so as to remain legible and affixed during the customary conditions of processing, storage, handling, distribution, and where appropriate, use". In English that means they gotta stay stuck and you gotta be able to read 'em. For as long as the product is saleable.

In order to discuss how to go about creating this guidance we brought in the esteemed and estimable outgoing ASTM D 10 chairman, Pat Nolan, to describe the process of creating a guidance document. It would seem that choosing from the cafeteria of possible tests and protocols and then gathering them into one concise and cogent document is the process that needs to be followed. Since Healthpack, folks have sent me a pile of standards from ASTM, TAPPI, ISO, TLMI, and a few other alphabet organizations. The next step in this process is to get a group together that can evaluate and pull together a suitable, logical group of tests and standards that provides the most effective and simple path to assuring that labels are legible and affixed over time.

I would propose forming a working group to brainstorm this guidance. I have far more standards and tests than I think we need to come up with a workable product. I'd like to see a group of people that has real world experience with labeling issues as well as qualification and validation processes to help pull this thing together. At our Healthpack meeting, at least three people sitting at the table were dealing with the daunting task of explaining to their Reg Affairs people how they could assure FDA inspectors that a new label material would remain affixed and legible over time. I think the guy in the photo above had just left a meeting with some Reg Affairs folks on the topic. I pointed out at the meeting that if you work for a long established medical device company your label stock is almost certainly the equivalent of a nicely maintained 1988 Chrysler Cordoba. Sure, it has the fine Corinthian leather, the big V-8, and the spacious head and leg room, but it uses outdated technology, is inefficient, and costs a lot more to operate than a 2011 Chevy Monte Carlo. The key is explaining that to the regulatory folks and documenting how you can be certain that the Monte Carlo will outperform the Cordoba.

Call me, 612.706.3742. Email me, dolson@advancedweb.com. If you are interested I'll send you the list of docs that I've collected with the help of IOPP MDPTC members (and Pat!) and we can begin what should be a rewarding and long overdue project. I'm looking for a few good women and men and the phone lines are now open.

Specifying label stock for your terminally sterilized package can bite you  in the derriere’ if you are not a bit of a pool player.  In other words you need to think ahead a couple steps, have some background history at your disposal, and be willing to brave the disapproving gaze of the quality folks, who would put a tolerance on your underwear if they thought they could get away with it.  There are many ways to specify material, label face stock and liner for this post, that will both guarantee consistent and functional labels on your package and also ward off unnecessary ECO/ECR print changes.

As most of us know, the FDA and other entities interested in device labels have two simple requirements, that the labels be legible and affixed.  They can’t fall off and you gotta be able to read em.  This would apply to the label facestock, the actual part with adhesive that sticks to the package.  There are a number of ways to describe label face material but the most common is to throw out basis weight of the paper sheet.  It is also by far the most useless and non descriptive identifier in use, but it’s on literally every print that comes across my desk.  Why you ask?  Because that’s the way it’s always been done.  My guess is that two out of 100 people actually even know what basis weight is.  I think it was invented by Johannes Gutenburg when he had to carry paper on his back to his new fangled printing press.  50# label refers to the weight of 500 sheets of 25” x 38” paper.  Can we verify that weight at Advanced Web?  Nope, it has adhesive on the back of it.  Can you verify that at your incoming inspection area?  Most certainly not, for the same reason.  Is the number useful for anything other as a nice number for people who like to quantify things?  It’s as useless as teats on a boar hog, as my Grandpa Larsen would say.  There are many other attributes that are more useful such as opacity, machine and cross direction strength, brightness, and the actual thickness of caliper, yet these rarely are seen on a print.  The other main pitfall of spec’ing label material is when the packaging engineer takes a data sheet from his helpful label vendor and just plugs in what he sees on that data sheet.  Invariably the paper company gives the sheet an exciting marketing/trade name like Scanrite, Laserbrite, JetLaser, TransTherm, or some other brilliant marketing designation that they are sure will make the sheet sell like hotcakes.  The name shows up on the print and 9 months down the road these same marketing wizards decide to change TransTherm to Transtherm II with a effective transition time from the original to the new sheet of about a month.  We often have to furnish a certificate of conformance on the label material and have to certify the actual material, which is no longer TransTherm but TransTherm II (actual case here folks).  We all know what happens then.  A flurry  of paperwork and emails involving everyone from package engineering to quality to the janitor.  Maybe there can be a deviation to use the ‘new’ stuff or maybe an ECO/ECR needs to be walked around in order to rescue the labels from the limbo that is quality hold.  Using that trade name is like someone asking you to make a ‘Xerox’ of a document, ‘FedX’ a package, or grab a ‘Kleenex’ to blow your nose.  Normal human beings realize that you want a copy, overnite air, and a tissue to clean your nasal passages, but we medical device people will immediately slam the brakes on.  If you happen to have a Canon copier, a next day air deal with UPS, or a box of Puff’s you will not be completing any of those tasks in the medical device world because the documentation and cert no longer match the print and God knows what horrible, non compliant things would occur were you to proceed with your copying, shipping, or nose blowing. 

How do we avoid these label specification traps?  Two things:  generic face stock specs that address the attributes needed for the label, and liberal use of the ‘nominal’ symbol, pictured above.  Generally terminally sterilized device labels are printed by the label vendor with colored logos and such, and the variable data is filled in with either thermal transfer or laser printers at the device manufacturer. General requirements are typically a white sheet, somewhere in the neighborhood of .003” caliper for decent opacity and strength, and a surface that’s receptive to either thermal transfer ribbon or laser toner.    When describing characteristics such as the useless basis weight or the much more useful thickness caliper, it’s instructive to know that those can also change with little advance notice and that there is a tolerance involved.  A 46# sheet might switch to a 44# sheet from a different mill and have the same caliper.  That’s where the magic and utility of the nominal symbol comes into play.  I believe this symbol was created or maybe discovered by a shadowy, furtive, long time packaging engineer at a large device manufacturer in the northern hemisphere.  Let’s call him GB.  While this symbol is not included in EN 980 yet, it should be.  That way, miniscule changes to attributes that don’t affect the form, fit, or function can be dealt with in an efficient and compliant manner.  Thank you GB for this service to humanity. I probably owe you  a beer.

The adhesive is the key part of the labeling system, the part that makes sure we meet that ‘affixed’ part of the requirement in CFR 21, Part 820 of the QSR, and I will write about that another time.  The third and last part of the label sandwich is the liner.  This is the part that you throw away, the part that keeps the adhesive from sticking to things you don’t want it to stick to and conveys the label from the adhesive coater to the converter to the device manufacturer.  There are only three things you could possibly  care about with liner.  1) Does it keep the adhesive from sticking to unwanted surfaces, 2)For laser printed labels, does it keep the label stock flat, and 3)For machine applied labels, is it strong enough to go through your equipment efficiently and without breaking.  Since all liners perform the first task there would seem to be no need to spec anything other than a liner being present if you are not laser printing or machine applying the labels. Yet just this year I had a customer ECR come through changing a spec that called out a 40# liner to the more accurate 42# liner.  If wasting engineering time and doc control time was an Olympic event they would be playing this company’s anthem as their corporate flag rose up the pole and their representative stood misty eyed on the medal stand. 

Here are a couple examples of actual specs out in the device industry today.  The first is what I call the time bomb spec, sure to blow up and cause angst, ECO/ECR’s, and feverish attempts to make anatomically impossible jumps through intimate body parts by people in several departments at both the label supplier and device manufacturer. 

-Facestock :Fasson Lasercopyjet 56 Flex, 56 gm/m2 matte white, flexible, woodfree machine finished paper with good opacity, excellent aborption and toner bonding characteristics.
Liner: AT 45 (45gm/m2 )light weight woodfree white kraft paper based on TCF pulp

This would be a generic version of the same material:

Facestock: 45# (nominal) white laser toner receptive paper, .003” caliper (ref)
Liner: Lay flat liner suitable for sheet fed laser imaging

One calls out a painfully specific material with very rigid, inflexible characteristics.  A change in any of those attributes would short circuit an attempt to issue a certificate of conformance.  The latter material spec describes the general physical characteristics of the label paper needed to successfully meet those two FDA requirements of label stock, affixed and legible.  If more device manufacturers used this approach it would result in a label product of equal quality, effectiveness, and compliance as well as drive dollars to the bottom line, dollars saved when wasteful non value added activities were eliminated from the labeling specification, documentation, inspection processes.

In two short weeks a number of us will be sitting in Albuquerque, New Mexico at the 2012 Heatlhpack event. This years IOPP Medical Device Techncal Committee meeting will include breakout sessions for the various subcommittees, including the Labeling subcommittee headed by yours truly.  I hope lots of folks will choose to ‘caucus’ with us.  Bring your ideas and feedback.   I’ve also been researching and prepping for this event extensively and am part of the advance team for  pre-event  venue evaluation.  Accordingly, I have assembled Dr O’s Guide to Albuquerque brewpubs and non chain, locally owned restaurants with interesting food. Those of you who joined me at Gus’ Fried Chicken and the Flying Saucer in Memphis know of what I speak. One of my goals as I careen through life is to avoid both light beer and Applebees.  In fact for roughly the last 40 years I’ve religiously sworn off Light beer during the 40 days of Lent and will be unable to enjoy a Bud, Miller, or Coors light with any of my fellow packaging professionals.  Shoot me an email and I will send you the  electronic version of the list, complete with links, or visit us at Healthpack for your very own printed souvenir copy. 

Our Minnesota senators and representatives on the Congressional Technology Caucus, Democrat and Republican, have signed a bipartisan open letter to FDA Commissioner Margaret Hamburg asking for, in effect, a streamlined,  more flexible and transparent FDA approval process.  Any time that Michelle Bachmann and Al Franken agree on something, the evidence of a problem must be overwhelming.  Medical device companies are behind this effort but I would suggest that they perhaps look at some of their own processes, notably in the area of packaging requirements, and do a bit of streamlining and flexibility addition of their own.  One of the things that’s made me crazy for years is the beloved Material Certification, Certificate of Compliance, or whatever it’s called at your company.  I am going to take the controversial position that this document,  a piece of paper without which our labels can’t be released to production, is, as my departed Grandpa would say, “about as handy as teats on a boar hog”.

The final straw that precipitated this tirade came earlier this week.  We had produced a label qualification run for one of our customers and sent it over to them.  The feedback we received was that everything went fine except we did not meet the requirement of packing them 1000 labels per roll, with double shrink wrap.  Our crime/transgression?  We only packed 500 labels per roll in the prescribed fashion.  Why?  Because they only ordered 500 for the qual run!  We received an email informing us of the egregious oversight,  asking for a Certificate of Conformance affirming that we would indeed pack them 1000 per roll when the production order was placed.   Over the years we have shipped this customer lots and lots of labels, most of which were nicely packed 1000 per roll and double shrink wrapped. When more than 500 labels are ordered, of course.

My eldest son owns a company in Portland, OR, a wonderful city with 45 beer brewing operations within the city limits. He recently sent me an email exchange with a customer, who had called one of their practices ‘stupid!’.  The email to his old dad read, “The good thing about owning your own business is that you can tell people to pull their head out of their ass”.  His response to the critical customer was, “Free life advice: you will elicit a better response if you refrain from calling people stupid. Thanks, Erik”.  Since I only own a wing tip of the Advanced Web Thanksgiving turkey, I will refrain from any name calling regarding the Certificate of Compliance requirement. I would ask however, that we take a look at just exactly what a COC/COM accomplishes in the goal of receiving the correct label component for your terminally sterilized package and being able to trace it if there is an issue.  In my opinion it accomplishes nothing.  Zero.  Nada.  We typically receive a print from our customer and do a ‘preflight’, a process by which we make sure we can access the label stock called out in the print, that the tolerances are correct, and that the label is produceable and repeatable.  We already have a change agreement in place with most medical device customers swearing on a stack of Bibles with Torahs and Korans interspersed in the stack, that we will change nothing unless we have written authorization from the medical device customer.  What these certs basically do is say, “Yup, per our agreement this is indeed the stock, ink colors, etc. that you called out on your print.  It’s exactly like the 63 other lots of this same label that we’ve sent you over the past five years and nothing has varied”.  In addition to this invaluable document, which is normally printed out and in an envelope stuck to the outside of a carton (or turkey?), our manufacturing lot number, the key to the critical traceability component, is inside the core of every roll, on the carton, and in every piece of paperwork relating to the shipment.  In the lean/value added process scheme of things, does this scrap of paper, the COC/COM, add any value to the label product?  Does it insure correct material?  Do we mobilize a detailed traceability process for each label order before the cert is issued, tracing the paper back to Aspen tree #435 on the SW of the SE 40 acres, Section 18, Town of Oulu, Bayfield County, Wisconsin?  My answer to those questions would be 1) No, 2) Nope, 3) Hell no!.  Some of our more proactive customers agree with that assessment and have dispensed with the cert process for every single order and instituted a ‘Technical Agreement’ in it’s place.  This is a legalese filled document, signed by both companies with sub headings such as Supply of Products and Related Information, Validation Requirements, Product Quality Obligations, and Quality Systems.  In a nutshell it says that the device company will provide us with prints and specifications, that we will mutually review and agree upon said prints and specs, and that we will not deviate from the print unless there is agreement in writing.  It is basically an overall Certificate of Conformance/Compliance. 
I’ve tried to shoot holes in this technical agreement process but have been unable to.  Using our job number we can trace label stock, ink, and our machine process back to vendor master rolls, ink batches, and which operators at AW performed each and every operation down to packing the box. As mentioned earlier, this number is all over the place on every label shipment.  If there is an issue of any sort, that number is used to access the entire job record including label retains.  How does generating a redundant piece of paperwork add to the value of the labels or the package they go on?  Do ya think maybe it wastes the time of customer service, final pack, shipping, receiving, incoming inspection, and quality personnel at both our plant and  our customer?  Precisely what function does certifying each and every batch perform?  Have perfectly good labels needed on the production line ever sat in incoming inspection because someone misplaced the cert?  If a batch is certified and there is indeed an error (humans involved here folks) will there be fines, suspensions, and a visit from the CAPA Police? Those are questions that need to be asked, considered, and honestly thought about. When I run through that question set I come up with the conclusion that the whole process is stu…….oops, poorly thought out.

I know that the Certification windmill will never succumb to my Don Quixote-like tiltings.  This very day we will dutifully generate some BS document, affirming our intent to rewind 1000 labels per roll (maybe also asking for deviations on any future engineering/qual runs signed and notarized by multiple company officers) and there will be muttering and snide comments made.  But if we are looking to the FDA to streamline their process we should also embrace the lean philosophy and do some common sense modifications  of  our own procedures.  Relying on the checks and balance of our  upstream vendors quality systems, all of whom we have audited,  qualified, and yes, certified, would be a great step and send a message that we are serious about getting devices to market quickly and safely.

We attended a medical device manufacturing event in San Antonio a couple weeks back.  The organizers were either smart or sadistic when they chose the venue, depending on your point of view.  We were held captive in a golf resort northwest of town, a $40 cab ride (one way) from the earthly pleasures of Riverwalk.  Early morning attendance was greatly increased but unless you wanted some high end retail experiences the location was a bit sterile.

When we arrived on Sunday we were also informed that, on a NFL Sunday, the bar did not open until 4pm and did not have NFL Sunday Ticket.  It was a sullen and demoralized crew that watched the exciting Jacksonville/Jets game.  Still, we were there for the advancement of medical device manufacturing knowledge and intelligent discourse on the issues.  It was a fairly high level group, yours truly excepted, but most of the attendees were well aware of labeling issues for terminally sterilized packaging and one of the issues that everyone has is the lack of  label real estate.

Our record at Advanced Web is 27 languages on one label.  My guess is that it will increase rather than decrease in the future.  Symbols, both EN 980 and ISO 15223 can help with the space management, translation costs, and lengthy lead times associated with the translation process. As most people know, a company can create and use its own symbols as well as long as they are explained, in 27 languages of course, in the IFU.

The printed IFU itself might go away when E Labeling is finally allowed in the EU, a rare instances where the FDA is ahead of the innovation curve on this type of issue.  As the Medical Device Directive and the Packaging Waste Directive trade body blows, toe to toe in the EU arena, I can't help but wonder the impact on labeling when this logical, cost effective, and green alternative to pitching a 48 page booklet in the dumpster is authorized.  My guess would be that with the information being electronic or on a disk, more information will be needed on the package labeling.

Unique Device Identification is another requirement that is coming down the pike. The Global Harmonization Task Force released its final rule on global UDI about 2 weeks ago. No matter how the program is implemented it will require valuable label real estate to implement.  Other standardization efforts are in the works as well.  There is an initiative in ASTM to come up with a standard labeling format for arthroplasty.  A guy I know even wrote an article in PMP News on the topic this month.  Once again the content of the label will need to be manipulated, in both instances for well thought out and progressive reasons, but nonetheless it's certain to use up more label space.

So what's the answer?  Heck, I don't know, I'm just a label guy who kicks out a blog now and then.  One thing would be more symbols and more standardized symbols.  There are plenty of things that are consistent across the board whether you are making pacemakers or spinal implants.  Size matters as well.  All of the devices I'm discussing are used by medical professionals; grandma doesn't have to read the verbiage with her +4.00 cheaters.  Six point type is readable, especially if you use a good, readable font such as Helvetica.  Stay away from the serif typefaces, the cute little fonts favored by more artistic types, with curly Q's and lines that vary in thickness throughout the stroke of the character.

Adding real estate is another solution.  'They ain't makin' any more land' is the common wisdom when you're complaining about the cost of real estate acreage but it's not true with label acreage.  The size of the label on the package can be maxed out.  On a four foot long introducer lead this is not a problem, on a relatively small pacemaker package it can be, which is a key issue with any standardization that is applied across the board.

Things such as expanded content labels, the little accordian fold booklets seen on many small packages, are one way to increase space for label verbiage.  Lots of questions but minimal answers at this time.  Varying package sizes need to be considered when developing standards that apply to everything.  Symbols should be the first 'go to' solution, and well designed and laid out labels should be the norm.  Think of your living room when guests are coming, not the closet you just threw all the crap from the living room into.  Finally expanded content or even simple two sided printing of the labels helps add real estate.  No matter how much you need now, it's pretty apparent that more will be needed in the future. It’s not too early to begin strategizing.

One of my avocations when I’m not completely immersed in the wonderful world of medical device labeling is kayaking.  Not the shoot the rapids type of whitewater kayaking in a boat that resembles a giant clown shoe, but sea kayaking on Lake Superior for multi day trips in long, skinny boats.  We don’t always find beer (see Shelf Life post earlier) but its always interesting and exciting.  Minnesota, a state that loves a good fee as much as any state, has us register our kayaks and, in exchange for our Krugerrands, give us two nice 4 x 4 labels with a big date on them to stick on our boats.  This allows law enforcement to easily view the date and fine us if it’s expired.  A stickers is issued for each side of the bow.  I noticed the other day that the port sticker had ‘fallen off’ my boat.  This sure looked like a classic adhesive failure to me but which adhesive property caused the failure?

There are  3 basic properties of pressure sensitive adhesives.  The first one is tack or quick stick.  It is the force of the label being pulled directly away from the substrate being labeled.  Depending on what you are labeling, aggressive tack can be good or bad.  Most hot melt adhesives have high initial tack while most acrylics have lower tack and adhesion that builds over time.  If you are slapping a label on a damp 35F milk jug or a small diameter vial then tack is desirable.  If you are labeling an expensive part or have critical positioning where the label might need to be adjusted, then that high initial tack is a bad thing.  Tossing or reworking mislabeled packages is something that line personnel hate almost more than anything.

Shear is the force across the adhesive, the ability to slide on a surface.  Shear is probably the least important of the three main adhesive characteristics for medical device packaging but it can be important.  If the label falls off, it may have really, really low shear properties on that particular substrate.  The one classic example of shear coming into play on a device package involves a cardiac product and a polyprop box that replaced a paper based set up box.  During ETO cycles the paper label wrinkled due to the expansion and contraction of the polyprop box.  By recommending an adhesive with lower shear the label was able to react and move a bit with the box and avoid wrinkling.  It still adhered just fine.

Last but certainly not least we have peel.  Peel is a crucial as well as easily measured characteristic.  There are ASTM tests and various 90 degree and 180 degree peel testers, a couple of which we have in the AW packaging lab.  There is also the time honored standard of picking at the corner of a label with the fingernail, lifting it, and either peeling it off cleanly, wrecking the label, or wrecking the substrate its adhered to.  The ensuing comments from ‘damn that came off easy’ to ‘s**t, I just trashed the label and package’ can be discussed and evaluated.

The three of course, are related.  If you think of a teeter totter, tack is the fulcrum.  Peel and shear are generally opposed.  A high peel strength adhesive generally has low shear strength and an adhesive with high shear generally has pretty low peel values.  Either one can have high or low tack.  With most device applications shear is the fat kid on the teeter totter, low on the ground and peel is the skinny kid, way up in the air.  The tack fulcrum can be either high or low depending on how strongly you want that label to stay on the package initially.  Tamper evident seals that go around a 90 degree angle come to mind, especially ones with the reinforced tear strip.  Those need some initial tack to stick reliably in order to give the adhesion time to build to full strength for the tamper evident feature.

So what the hell happened to my kayak registration sticker?  Taking the substrate out of the equation (that could be another whole post), most registration/license tab adhesives have very high tack.  The sticker was on there for a few months, plenty of time for the peel properties to build to full strength.  Shear is not an issue because I can’t imagine it sliding off the boat.  That leaves peel.  I suspect that someone, using the manual peel test I described above, heisted the thing because they were too cheap to register their own kayak.  No, you conspiracy theorists out there, I didn’t peel it off to stick it on another one of my kayaks.  I tried peeling another expired one off and it was extremely difficult but not impossible.  The bottom line is that it could not possibly have fallen off and  I guess that’s the end goal for our medical device packages as well.  It can’t fall off.  Peel strength criteria is set, hopefully using a pass/fail criteria of some sort, in the validation and qualification process, and the label and package are on their merry way to the end user.  Now all I have to do is decide whether to spring for the six bucks for duplicate stickers or attempt to talk my way out of a fine if the warden spots me.  Advice will be appreciated.