nano4u
nano4upharmaceuticalwhitepaperauthenticationoftabletswww.nano4u.net
AuthenticationofTabletsPharmaceuticalWhitePaper
nano4uAGMarktstr.266060SarnenSwitzerland
[email protected]:+41-41-660-0927
nano4upharmaceuticalwhitepaperonauthenticationoftablets 2
Global trademeans that extra effort is required to protect one's products from themanufacturing line
throughdistributiontothepointofsale.Inparticular,itisnotenoughtotrackandtracepackagedproducts
throughthesupplychainusingprinteduniqueproduct identifiersandserializationsystems,becausenew
serialization requirements in many countries also require proof that the contents of the packages are
actuallygenuine(authentic)andcanbeauthenticatedeasily.This leavesproducerswithnochoicebutto
investinauthenticationtechnologiesiftheyintendtocontinuesellingtheirproductsinthoseterritories.
Unfortunately in the pharmaceutical market at present, individual products are still mostly secured by
logistics, i.e., track and trace systems, which are only useful to track groups of products but not to
authenticate the individual products. By legalizing re-packaging of goods, the current track and trace
systems have become ineffective for the purpose of protection against counterfeit pharmaceuticals.
Criminalenterprisesincreasinglyexploitthisfundamentalweaknesstointroducefakepharmaceuticalsinto
thelegitimatesupplychain.
In thiswhite paperwepresentnano4u's unique authentication solutions to overcome this gap – these
allowtrue-authenticationofpharmaceuticalproductsthemselveswithinasecondarypackagebycreatinga
linkbetweenthephysicalpropertiesofthemedicationitselfwithtrackandtraceinformationcodesprinted
on the package, i.e., the unique product identifier. Using established production technologies, our
authentication solutionsarehighly cost-effective formassproduction . nano4u– solutionsdonotadd
anymarkingagentstoproducts.
nano4u's authentication solutions are fully compatible with all global serialization standards. It
complements them with true authentication capability on the level of the individual product
(pharmaceuticaldosage form). It thereforealsosimplifies inter-operabilityand reliabilityofandbetween
variousdifferentnationalorregionalserializationsystems.
TheStateoftheArt:SerializationandAuthentication
Tofightthegrowingproblemoffalsifiedmedicines,whichformamajorthreattopublichealthandsafety,
differentregionsandcountrieshaveintroducedtheirowntracking,tracing,andauthenticationlegislation.
In theEU, theFalsifiedMedicinesDirective (FMD) requires the introductionofa full trackingand tracing
systembyFebruary2019.Medicinepackswillneedtocontainauniqueproductidentifier(2Dbarcode)and
ananti-tamperingdevice, i.e.,atechnicalmeanstoensurethatthecontentofthepackagehasnotbeen
tamperedwith.Inmanycases,industryistryingtouseso-calledtamper-evidencelabels--thatis,labelsthat
are glued over the closing mechanism of the packaging carton. However, such labels only provide the
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impressionofsafetyandsecurity,astheyareeasilycopiedbycriminalorganizations.Inaddition,genuine
pharmaceuticalcartonboxesquiteoftengetre-introducedintothetradebyhospitalsandotherplayersin
thethirdworld.
The track and trace systems being implemented by pharmaceuticalmanufacturers in Europe and other
parts of theworld aremostly basedon serialization,where, in addition to a drug identificationnumber,
batch number, and expiry date, the unique product identifier (a randomly generated serial number) is
printedon the secondarypackageofpharmaceuticalsasa2Dbarcodeand stored ina centraldatabase.
However, the unique product identifier neither authenticates the package nor its content, because an
originalcodecanbeeasilycopiedand/orthecontentofthepackagecanbeexchanged.Ifaduplicatecode
is scanned in the supply chain, the original cannot be distinguished from the copy, legally requiring the
manufacturertorecallanddestroythebatch.
Thereareliterallyhundredsofsmallandlargercompaniesthatprovidesolutionsagainstcounterfeitgoods,
usingovertandcovertsecurityfeatures.ThesetechnologiesrangefromsecurityhologramstoUV-visible
ink, magnetic pigments, DNA tagging technologies, and RFID chips, to name but a few. Apart from
holographicfoilsonblistersandchemicaltaggantsonor inthetablets, littlehasbeenappliedtodateon
the tablets or the contents of the pharmaceutical package itself. As shown in table I below, most
establishedauthenticationactivitiesarelimitedtosecuringthesecondarypackage(thecartonbox),notits
content.
Thecurrentstateoftheartthereforecanbesummarizedasfollows:
• Theserializationnumberdoesnotauthenticateapharmaceuticalproduct
• If themanufacturer can not authenticate the content of a pharmaceutical package, it has to bedestroyedbylaw
Thedrawbacksofcurrentlyavailableantitamperingandauthenticationmeasuresare:
• canbeeasilyfaked(securitylabels)
• areprohibitivelyexpensive
• trackproductionbatchesatbest
• requireexpensiveequipmentandtimeforauthentication
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TableI:Overviewofexistingauthenticationtechnologiesandtheirapplicationtopharmaceuticalpackaging
Technology Appliedto Comments
SecurityInks,UV,DNA,magneticparticlesetc.
• Secondarypackage(cartonbox)
• Blister
• Canbehighlysecure
• Doesnotauthenticatedosageform
• Expensive
• Requiresdedicatedinstrumentationforauthentication
RFID • Secondarypackage
• Blister
• Dosageform(Tablets)
• Prohibitivelyexpensiveeveninlargequantities
• Easytofake
• Althoughvariantsfortabletsexist,marketpenetrationvirtuallynon-existent.
SecuritypapersandLabels,hologramsetc.
• Secondarypackage
• Blister
• Commonlyavailable
• Veryeasytofake,ashundredsofcompaniesdothesamething
• Costsatleastaround1cent/packageeveninlargequantities
Taggants • SecondaryPackage
• Blister
• DosageForm
• Authenticatesproductionbatches
• Highlysecure
• Requiresnewregulatoryapprovaloftablet
• Requiresdedicatedinstrumentationforauthentication
Inkjetprintableinks • SecondaryPackage
• Blister
• Notpracticalondosageformbecauseofslowprintingspeedandrequiredregulatoryapproval
• Expensive
Digitalwatermarks,etc. • SecondaryPackage • Easilyfaked
• Accesstodatabaseneeded
• Doesnotauthenticateproduct
• Economicsolutionatlargevolume
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nano4u:ABetterWay
In nano4u’s unique approach, pharmaceutical dosage forms are microscopically marked in the tablet
pressusingminutegeometricalchanges inthepressingtools.Oncethetablets fromdifferenttoolshave
been placed in a blister, the sequence of thesemarks in the blister is a unique truly random code that
identifies this particular blister itself. This truly random code is read on the blister line with industrial
camerasathighspeedsandcryptographicallysecured.Astheblistersareplacedinthesecondarypackage,
theirsecuredrandomcodeservesasabasistogenerateauniquetrulyrandomproductidentifierprintedon
the package.A cryptographically secured link is created between the physical properties of each tablet,
theirarrangement inablister,andthesecondarypackage.Any illegalattempt tobreak this link iseasily
detectedby takingaphotographofablisterandsecurelychecking itagainst thecodeon thesecondary
package.
TableII:Manufacturingofaself-authenticatedpharmaceuticalpackage
Tableting
Coating Blistering
Insideatabletpress,stampspresspowderinto tablets. A single press contains up to160 stamps. As every stamp is slightlydifferent, these variations are transferredto the tablet and serve as a uniquefingerprintforeverytablet.
The unique fingerprint of tablets can bemeasured even on coated tablets usingnano4u’s proprietary technology.Bymixingtogethermillionsoftabletsfromhundreds of different tools in production,the coating step actually guarantees thattablet positions in the final blisterpackagingaretrulyphysicallyrandom.
The tablets are placed into a regulararrangement in each blister where theyform a truly random physical sequence.Measuringthefingerprintsofthetabletsonthepackagingline,thisrandomsequenceisread and cryptographically secured withadditional information about the package,such as time of manufacturing, batch nr.etc. A truly random product identifier isgenerated and printed on the primary orsecondarypackage.
Allinformationrequiredforauthenticationisontheproductanditspackage.Aself-authenticatingpackage
does not require connection to any external database for authentication. The authentication works
anywhereintheworldwherethereisaccesstoasmartphonewiththecorrectcryptographicauthentication
software(app)installedonthedevice.
Ascryptographyisusedtolinktheactualdosageformstotheirpackaging,pharmaceuticalcompaniescan
alsobettercombatillegalre-imports.Individualcryptographickeyscanbeprovidedtoeachmanufacturing
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site and quickly changed should a problembe detected. Illegally repackaged content can thenbe easily
identified.
TableIII:Self-authenticationinthefield
Anywhereintheworld,thesequenceoffingerprintscanbereadwithamobilephoneandcomparedwiththeprintedserializationcodeonthepackage.
If the sequence of tablet fingerprints in the blister matches thecode,thepackagehasnotbeentamperedwith,asanytamperingwill destroy the cryptographic link between the physical tabletsequenceandthecode.Thistrueauthenticationdoesnotrequireanyexternaldatabaseaccess.
Our cryptographic solutions and smartphone-based reading apps can use the aggregation of coding on
product and blisters (primary packaging) aswell as serialization-compatible coding on carton boxes (2D
barcode)tocreatefullyself-authenticatingpackages.Thesecanbetrulyauthenticatedinthefieldwithout
requiringcentraldatabaseaccess,whilebeingfullycompatiblewithexistingdatabasesolutions.nano4u’s
uniqueapproachprovidesreliablecompatibility/interoperabilitywithcustomersupply-chainmanagement
andespeciallyERPsystems.
The linking (or data aggregation) solution between physical product properties and packaging is highly
secure, and it is the only means available to truly authenticate pharmaceuticals without requiring the
destructionofthepackageormedication(suchas inthecaseofchemicalanalysis)oraddingtaggantsto
theformulation.
Fastandfullysecureauthenticationisespeciallyimportantincasesofproductrecalls.Forinstance,where
counterfeit products have been detected in the supply chain, self-authenticating packages allow the
manufacturerstodistinguishbetweenillicitandlegalproductsanywhereintheworld.Manufacturersand
distributors can therefore avoid return shipments and the destruction of large quantities of legitimate
products, because their authenticity can be truly established on the dosage form level.
Self-authenticating pharmaceutical packages therefore improve the resilience of complex supply chains
effectively, as the approach is easily scalable globally and does not require additional physical
infrastructureaftermanufacturing.
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Self-authenticatedpackage:Easytouseandverycosteffective
Proprietaryproduction-proventechnology isusedforourauthenticationsolutions.Fortabletproduction,
absolutelynothingischangedfromapprovedandvalidatedprocesses.Forimageacquisitionandscanning,
establishedtechnologypreviouslyusedinotherindustriesisapplied.
Our field-levelsimpleauthenticationusesestablishedsmartphonecameras,combinedwithdigital image
analysis and cryptography. This provides a first level of authentication. Whilst this is not forensic, the
reliabilityoftheauthentication,especiallyifmorethatoneblisterinacartonischecked,isextremelyhigh.
For forensic-level analysis (analogous to analyzing the paper of a bank note), microscopic features on
tablets, includingsurfaceandsub-surface,arerapidlymeasuredthroughtheblisterbyopticalhigh-speed
scanners.Thistechnologyallowsrapidacquisitionof3Dtomographic informationofthetablet insidethe
blister.Withinsecondsouruniquealgorithmsthenallowauthenticationofindividualtabletsontheforensic
levelwithoutphysicalcontacttothetablet.Theblisterandthepharmaceuticalpackageremainfullyintact.
Our systems are highly cost effective, as they do not require any changes to existing production or
packaging lines.Theyworkwithoutusinganyadditionalmaterialonthepackageorproduct.Thecostof
manufacturing using our solutions for large quantities of pharmaceutical tablets is converging towards
zero,instarkcontrasttoallotherexistingtamperevidencesolutions,whicharecharacterizedbyanalmost
linearcorrelationbetweencostandoutput(mainlybecauseoftherelativelyhighcostoftamper-evidence
labels).Ourauthentication solutionsare fully compatiblewithFMD regulationsandcanprovide for fast,
reliableandfulltrackingandtracingalongthesupplychainwithouttheneedtodestroytheproductduring
authentication,whileenablingtrueauthenticationontheproductlevel-notjustthepackage.
nano4u-SupportYouCanCountOn
nano4u has the expertise and integrated products/technological know-how to help you protect your
product’s integrity and security across the global supply chain. We understand the complexities of
internationalsecurityregulationsandcanhelpyoumaintaincorporatecomplianceatreasonablecost.Our
integratedtechnologysolutionscanhelpyoutoprotecttheintegrityandsecurityofyourproductsandto
maintainyourbrand’sreputation.
nano4uhasverypowerful tools available toauthenticatepharmaceuticals anywhere in theworld, even
withamobilephone,andwithoutcentraldatabaseaccess.Havingfast,simple,andreliableauthentication
capabilitiesthroughoutthesupplychainstronglyincreasessafetyandsecurityofpharmaceuticalproducts,
andthesesolutionsmakeitmuchmoredifficultfororganizedcrimetodistributefakemedication.
Copyright©nano4uAG,Sarnen,Switzerland,January2018