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:
- 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.
- 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.
- 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:
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.
One of the more interesting aspects of medical device manufacturer’s view of the label industry is their belief that our raw material suppliers, the folks that produce the label stock that we convert, actually care about the time it takes for device manufacturers to qualify a new material. The unvarnished truth is that they just don’t. The entire label stock usage for the entire medical device industry is a gnat on the elephant’s backside of total pressure sensitive material volume. What that means is that if there is a new face stock or adhesive out there that performs better at less cost, PS label stock coaters are going to implement the new product and dump the other one. The typical timing of this process from when we label printers hear about the material change to the date the old stock is laid to rest is typically about three months.
We recently received a communication from one of our customers asking us to reaffirm that we agreed not to change or discontinue any part or component of any part that we supply to them for 18 months. After wiping the tears of laughter from my eyes, I politely explained the typical three month window along with our vendors almost complete lack of sympathy for their plight. It was like they didn’t even hear my response. Like the ugly American that speaks slower and talks louder to a non- English speaker, our customer reiterated that 18 months was the requirement. At this point we were in a house Republicans v Obama-like standoff. I will keep the readers informed of how this impasse plays out. One disturbing point that I made was even if the customer authorized us to purchase 18 months worth of inventory, the shelf life on most paper label stocks is one year. Beware of Catch 22, this will be interesting.
In the past couple of years, the number of materials changing due to performance issues or component shortages has almost doubled. Some changes are more major than others but three very different short case studies will illustrate some of the angst. In the first a very familiar trade name of a long lived 60# cast coated high gloss sheet, Kromekote, was discontinued. Had the description on the label drawings / prints been generic, 60# cast coated high gloss, everyone would have been fine. Instead of Gold medal flour they could have simply switched to Pillsbury’s Best, pretty much the same stuff with a different brand name. Unfortunately all the prints said Kromekote, and since we need to issue certificates of conformance saying that the product we produced was indeed Kromekote, the ECR/ECO process swung into high gear. Panic ensued and after much frantic qualification, validation, fines, and suspensions, justifications were put into place to allow the change.
Case study number two involves a .002 vinyl face stock that was discontinued with virtually zero notice due to a supply chain issue. How vinyl was approved in the first place for a device application given its health concerns, toxic environmental waste, and plasticizer migration issues is beyond me. In this case the .002 vinyl was replaced with .002 PET, a face stock in common usage in the device industry, especially in autoclave applications. All the companies affected by this material change use PET and have extensive test data on its performance. In addition, the topcoating for TTR printing is the same, the adhesive is the same, and the liner is identical as well. We are still in mid chaos on this one as well with no resolution as of yet.
Lastly we have the case of the changing adhesive. One of our vendors has discovered that the shear properties of one of their adhesives has been decreasing, pretty much from lot to lot. They contacted their adhesive supplier who told them that the issue could not be improved. The decision was made, after pretty extensive testing, to replace the adhesive with a newer, higher performing product. This change is far more serious and has greater impact than the first two cases because the adhesive is the key component, the element that provides the long term chemical bond between the label face stock and the substrate labelled. In this case the window was three months but we have the ability to order as much as we need before it’s discontinued. Inexplicably, even though this information was sent out in mid-November to the affected device companies, no additional material was ordered to tide them over during the testing process of the new adhesive .
I will resist my natural surly and curmudgeonly opinions on the above three case studies and attempt to offer a few things that can be done, both to prevent the problem and help solve it when it does pop up. The first thing to do, a trick that I’ve written about on this blog before, is to avoid trade names of label stock like I avoid clichés; like the plague! You don’t want Kromekote, Scanrite, or Transtherm II or any of that junk on a print. Ever! All it does is box you in and create more issues. A generic description with liberal use of the nominal symbol such as 60# (nominal) cast coated high gloss or perhaps .0035” (nominal) thermal transfer receptive paper will avoid chaos when the paper mill switches to LustraGloss, ScanPerfect, or Transtherm III. Another good idea is to have a reasonable protocol for testing a label material with a minimal component change like occurred in case #2, a sort of 510(K) for label stock. In case #2 the new construction is more than Substantially Equivalent to the nasty vinyl that it’s replacing plus there are reams of test data on the performance of PET on terminally sterilized device packaging. Finally, order enough label inventory so your package engineering and regulatory people have some time to do what they need to do. Shelf life for paper is typically one year and films are two years so order enough to make the qual time frame comfortable.
Healthpack is in two weeks in beautiful Norfolk, VA. I don’t know about any of you but I plan on touring the USS Wisconsin, named after my home state, as well as attend the sessions. You can debate and/or ask me how these case studies turned out as we enjoy the hospitality that is Healthpack. I will also be in Vegas the end of March for the AAOS convention and we will be sponsoring a happy hour along with several other MDRG members. At both events I will be accompanied with my partner in crime, Blake Insteness. I hope to see you at one of these fine events in the near future.
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.
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. My personal experience with this is very much like the Vikings record this year; five nicely designed and properly weighted evaluation tools, ten myopic bottom lined focused ones, and one on the fence. 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, major league pissed in many instances, 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 I 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 Dr. O Label Audit. That helps pinpoint areas where savings can be realized.
In the upcoming AWT World Tour, I will be in Anaheim for MDM West next week and then back to Albuquerque in March for Healthpack. Cautious packaging professionals that are concerned about the heavy snow in the New Mexico area can rest easy. I will be up in the mountains near Taos for several days prior, carefully checking and inventorying the snow pack for any potential flooding or avalanche threats to the greater Albuquerque area. I hope to see a few old acquaintances in both venues and would love to have you shoot me an email if you are going to be at either venue, email@example.com.
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!
|0. integrated||0. management||0. options|
|1. total||1. organizational||1. flexibility|
|2. systematized||2. monitored||2. capability|
|3. parallel||3. reciprocal||3. mobility|
|4. functional||4. digital||4. programming|
|5. responsive||5. logistical||5. concept|
|6. optional||6. transitional||6. time phase|
|7. synchronized||7. incremental||7. projection|
|8. compatible||8. third generation||8. hardware|
|9. balanced||9. policy||9. contingency|
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 firstname.lastname@example.org 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: 184.108.40.206 – 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.