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.

A few years back I had a couple  hernias repaired using surgical mesh, a product much like those rolls of garden mesh that keep hilly areas on your property from eroding.  When asked in post op to describe my level of pain from 1 to 10, I was unable to come up with a number because at that point the anesthesia made it impossible for me to locate my own ass with either hand.  However when asked if I’d like a morphine drip I knew the answer to that question immediately.  Surgery went great and I was back at my desk early, wading through emails.  About the 5th one I looked at was an FDA alert describing counterfeit hernia mesh that had been discovered in the US healthcare system.  I got on the phone to my doc, who knows me well and kept waiting for the punch line when I described the ersatz mesh.  I had to send him the email, more than a bit perturbed that a lowly label bum knew about the problem before the guy that probably stuffs several of these mesh products into patients every week.  As it turned out I was fine as the mesh that was placed in me, ruining the look of one of the finest navels around if I do say so myself, was from a different manufacturer than the one the counterfeiters had targeted.  It may or may not have helped, but having an additional level of security provided by a well designed tamper evident label on the package may have made the counterfeiting more difficult.  In the actual alert the very first criteria that they used to describe the bad device was, “A packaging seal that does not tear open smoothly”.

Tamper evident labels are pretty simple.  Notice I don’t say tamper proof, since that’s an impossible claim.  Nothing is tamperproof, waterproof, or idiot proof.  The goal is to make it evident and obvious that someone has attempted to breach the package to get at what’s inside.  This is done by by either the label fracturing, delaminating, or leaving a gooey mess where it was on the package or the adhesive bonding with the package substrate to the point that it destroys the package material if removal is attempted.  The most basic illustration of this concept is the simple price sticker on a product that can’t be removed in one piece.  The epitome would be a package like a CD jewel case or any electronic device that practically requires a switchblade, hammer & chisel, and a pound or two of C4 plastic explosive to open it up.  Which brings up a critical point with medical device packaging.  It has to be tamper evident yet easy for the OR staff to open, use, and offer a good solid visual as to whether the package has been tampered with.  The original tear tab or tear strip was developed as a result of physician complaints.  The simple round or rectangular destructible label worked OK but to get it off required either a fingernail, tough when a person is wearing surgical gloves, or the use of a scalpel which then had to be tossed.  The simple label is also pathetically easy to copy and fake.  So……..tamper evident/indicating and simple and reliable for surgical personnel to open. That seems pretty straightforward but, like most things in our industry, it just ain’t that simple.

There are a few issues that complicate the medical device tamper evident package label and they can loosely be grouped under sterilization, package conditioning, label function, and good ‘ol ASTM 4169.  Certain films commonly used for tamper evident seals do not like gamma radiation and they also do not do well at the higher accelerated aging and conditioning temps sometimes used when…gasp….validations and quals are behind schedule.  Also, using the tamper evident label to hold together a SBS folding carton that’s stuffed with the double barrier package, a warranty card, and a big thick manual will almost certainly cause it to fail ASTM 4169, the shake, rattle, and roll test.  So will the theory “gee, it passed ASTM 4169, lets add a ‘spike the football’ test to the protocol as well”.  You think I’m exaggerating?  Unfortunately only slightly.  Frankly, if the seal breaks when you thump the package you should think about what’s happening inside the box, the canary in the coal mine theory. Finally, when the label is placed on the package there needs to be a clear work instruction about where it goes on the edge of the box.  We often print tick marks to aid in this process.  These labels typically have a reinforced peel area with small nicks to make sure the peel is reliable and secure.  If it’s lined up wrong it can tear prematurely.

Actually there are a few more nuances but the ones above are plenty for a blog post like this one.  Levels of security can be added like adhesive void components, holograms, color shift inks, etc., but the basic version seems to be functioning quite well and has been well received in the medical device marketplace.  Its a small item that can pay big dividends if any product integrity issue do arise.

Foreign material or FM can be loosely defined as something that’s not supposed to be present or part of the base material that’s  being produced.  The fact is that foreign material is always present in everything that is produced, no matter how much we wish that it wasn’t or how strictly we word our engineering drawings.  It will be there so the key issue, twin issues actually, are how much is allowable and what exactly is the composition of the FM.

In the photo above its pretty clear that the allowable ppm of foreign material as well as the maximum size of the particulate has been exceeded.  That’s what can happen when a couple of guys are tinkering with ink pump hoses that are under pressure.  We know what the ‘foreign material’ is however.  It is solvent safe water based black ink, approved for indirect food contact under FDA regs.  Is it a health hazard?  Not according to the MSDS sheet.  Does it pose some disturbing cosmetic issues for those who might encounter these two yahoos?  I would say the answer there is yes.  So we have a known substance that is relatively inert, but just doesn’t look that great. Coincidentally, we had the same issue with some laser face stock from one of our suppliers.  It opened up a large can of worms in regard to what it actually was, how much was allowable, and the perception of how it looked on a package.

In November of 2010 we began to see large (some half the size of a fingernail) spots on one of the paper laser sheets that’s qualified and validated at a number of our device customers for labeling terminally sterilized medical device packages.   The paper industry has not been exempt from the go faster/make it cheaper pressures of the marketplace and we suspect that increased machine speed and less inspection might be the culprit. We discovered that the foreign material was calcium carbonate (which would actually make it parent material by definition) used in the paper making process. It’s a naturally occurring mineral and is commonly used, among other things, as a calcium supplement in diets and a key ingredient in antacids. Basically, people can eat it.  Unfortunately, these specks had a rust colored hue, a color that looked very similar to dried blood.    Our supplier had no interest in attempting to correct the issue since medical device usage is the proverbial flea on the elephants butt of total laser paper usage.  We were sent a letter informing us that our vendor would no longer support our medical device application in early May of 2010. We informed our device customers and the gnashing of teeth and over thinking of the issue began in earnest.

The perfect solution would be not to have any at all. Unfortunately, a line on a  drawing or print that says “There shall be no foreign material present on the printed side or adhesive side of the label” does not make the FM go away or even scares it a little bit.  For example, neither you nor I want insect and rodent parts or mouse dung in our bread.  Yet the FDA, those same guys that regulate our industry, have an allowable ppm for those very substances in flour.  I worked in a bakery during part of college and one of my jobs before the inspectors came  through was to thoroughly clean the dough mixer and vacuum up all flour bug tracks underneath it.  At times it looked like Grand Central Station under there. So the real question becomes how much FM would be allowable?

Enter the venerable TAPPI chart.  The most widely accepted particluate standards were developed in 2004 by Tyvek and film converters. Some of you may remember the 1073B Tyvek recall in 2001, when black FM from deteriorated brushes in the Tyvek production line in Richmond broke off and became embedded in the sheet.  Many device manufacturers had standards before that and an ASTM group headed by some J&J folks attempted to come up with a standard but it never came to fruition. The current most commonly accepted working standard combines both embedded and loose FM with a maximum allowable size and maximum particulate count for smaller sizes.  It addresses both parent material, components of the actual structure itself, whether it be Tyvek, film, or paper, and foreign material that is not part of the manufacturing process.  If you sent him a nice email, Mr. Curtis Larsen of Spartan Design Group might send you a copy of some work that he did on FM on various substrates.  Just don’t mention this years MSU basketball team.  The other key part of FM evaluation is that the parts need to be examined at 18″ with the unaided human eye for two seconds.  Poring over a label or lid for 20 seconds with a 6x magnifying loop is definitely not the accepted procedure.

The FM in the laser sheet face stock issue is still unresolved.  Qualification and validation of the alternative cleaner, more bright white materials is crawling along at glacial speed at exactly 100% of our customers.  However the main thing that dealing with the medical device industry has taught me is patience.  One of my MedDev buddies, an engineer at a large device manufacturer, counseled me, “Olson, you gotta be patient.  If the FDA regulated the auto industry your car would not have an electronic ignition and it wouldn’t even have points and a condenser.  You’d have a magneto because magnetos are historically proven to be reliable”.  It is the same with implementing  the commonly accepted FM standards.  2004 to now is a mere blink in both geological and medical device time.  I would encourage medical device companies to at least lurch forward toward adopting a practical and workable FM standard

Healthpack was the usual rousing success with a sellout crowd at the Gunther Hotel and along San Antonio’s Riverwalk. There were some casualties in the rough and tumble world of terminally sterilized medical device packaging but for the most part things were under control. I think the gentleman in the photo was an innocent bystander in a river front brawl between the ISTA and ASTM 4169 gangs over the package distribution standards turf. Another rumor was that the E labeling posse and the printed leaflets/IFU boyz came to blows again, but it’s unclear at this time. It was a good conference though, and many of the topics were germane to the issues of the day and a number of new ideas were explored.

When good HealthPacks go bad...

One of the more interesting ideas was proposed by Nicholas Berendt of the Sealed Air Corp., a converter of sterile barrier packaging. The theory was if the converter, (eg the company that takes raw material and prints, diecuts, laminates, folds, spindles, and mutilates it into pouches, lids, labels, IFU’s, etc.), could to a series of tests up front and provide data, it could seriously reduce package engineering  time validating new packaging films as well as increase speed to market.  I have thought for a number of years that the same thing could be easily done with new label stock.  The testing is not nearly as rigorous as what would be needed for a barrier film and pre qualification might make it easier to qualify and validate new label material.  As I mentioned in my Healthpack presentation, labeling is usually a very small part of the total package as far as cost and time and effort thats devoted to it.  Because of this, available engineering time to test new materials, including label stocks, is generally limited and not in the number one spot on the package engineering agenda. Due to this ‘fact of packaging life’, the older, larger, more established companies are driving the ’89 Chrysler Cordoba of label stocks while newer companies, who have to evaluate all their new packaging materials anyway, are zipping along in the ’09 VW Passat, 1.8L Audi Turbo label stocks.  While it’s true that the established firms have the fine Corinthian leather, they don’t have all the new innovations and added features of the newer models.  These would include brighter, whiter, more opaque face stocks and tackfied emulsion adhesives that have decent repositionable characteristics in final pack yet superior ultimate bond to tough substrates like tyvek.  Plus the new materials are a solid 25% less costly than the older materials.  That should make the purchasing and sourcing peoples ears perk up but again, as a percentage of the total expense of the product the label part is still puny; we’re talking about a deck chair on the Titanic here.

Distinguished gents of HealthPack

The question then, is if we performed a series of ASTM and other tests on new label stock that addressed the twin FDA regulatory concerns in CFR 21, Part 820, the Quality System Regulations, of adhesion and legibility, would that be of value to device manufacturers and in particular packaging engineers?  I realize that package size and weight are crucial to package testing and that special conditions need to be considered for various configurations, but I can’t help but think that if you need to get from Minneapolis to Milwaukee, that starting out in Madison would be a lot quicker, less costly, and less painless than starting out in Minneapolis.  Please weigh in on the attached poll and let me know how you feel your company, particularly your Reg Affairs folks, would react to this concept.  I will anxiously await your feedback.

Almost 174 years to the day, after Jim Bowie, Davy Crockett, William Travis, and a couple hundred others were killed defending the Alamo, the upteenth annual Healthpack Conference is coming to within 4 blocks of the historic mission in San Antonio, TX.  In a weak moment I was approached by the instigators (agitators?) of the event, Messers Spitzley and Larsen, and agreed to craft a presentation which they entitled, “How to test your package system labels for materials compatability and adhesion over time“.

It’s a critical topic but what we discovered in a survey that was taken by the IOPP Medical Device Technical Committee’s Labeling Task Group, no one does it exactly the same.  The FDA gives us a broad and general edict in the Quality System Reguilations, CFR 21, Part 820, Subpart K.  “Label Integrity.  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 a nutshell, the label needs to stick to the packaging component substrate and stand up to the abuse of sterilization, shipping, handling, and storage until it gets thrown away.  It also needs to remain readable after this journey from manufacturing final pack to the landfill.  How to test for these qualities and predict how well the labeling on a terminally sterlized device package will survive is the topic I’ll try to address.

Rather than standing up there and presenting what I think people  are interested in, I thought I’d use this forum to see what people that work with device labeling day in and day out actually want to hear.  Take a look at the survey that we took last fall (attached below), which had ten basic questions.  Part of the presentation will be based up on those responses, which come from a broad spectrum of device manufacturers, but I know there are additional  issues, test methods, and techniques that should be addressed.  One of the things we are working on in the Labeling Task Group is some sort of protocol or guidance that can be used to help qualify and validate pressure sensitive labeling of terminally sterilized device packaging.  Any feedback via email or blog comment section would be helpful to the group.

Labeling Task Group 09

I know budgets are tight but Healthpack is a pretty useful conference for those of us in medical device packaging.  I can’t pretend that all the presentations have been scintillating over the years, but there are a heck of a lot more useful and interesting presentations at this event than at most others I’ve attended.  There is nothing wrong with San Antonio, the historic Gunther Hotel, or Riverwalk either, for that matter.  Please take a couple minutes to give me some feedback on the topic of pressure sensitive labeling.  If you don’t who knows what you might wind up with in early March…..