T E C H N I C A L
B U L L E T I N
Package Authentication Security Solutions PASS is a comprehensive program of anticounterfeiting solutions that provide package protection and authentication to assure product confidence across your supply chain
PASS: Package Authentication Security Solutions PASS is an integrated set of technologies that when combined provide a resilient anti-counterfeiting program customized to match your requirements. Counterfeit products have major financial and health implications, and may cause your brand irreparable damage. It is about building consumer confidence in the products they buy and protecting the trust placed in your products. That’s why Disc offers you the latest in anti-counterfeiting protection and authentication to assure the quality and security of your products will not be compromised.
Level 1
Signature DNAÂŽ Irrefutable forensic evidence of authenticity
Level 2
Device Required Field Authentication including encrypted QR (Quick Response) Codes, Fluorescent Coatings and inks that react to UV light, micro printing
Level 3
Visible Brand Identifiers for easy verification by brand owner, supply chain partner and consumer
A multi-layered approach customized to your requirements
Who should be concerned about counterfeit products? By virtually all estimates, product counterfeiting poses a serious global challenge. According to the United Nations Office of Drugs and Crime (UNODC), “the branding of a product provides implicit quality assurance and a legal line of accountability that consumers have come to take for granted. Without a brand to protect, counterfeiters have no incentive to produce anything but superficial quality. Where it becomes impossible to distinguish the real from the counterfeit, poor quality products destroy the reputation of the copied brand, and the cheaper goods will inevitably dominate. The ultimate threat of counterfeiting has been realized in some parts of the developing world: the original, high-quality products have been essentially priced out of the market.” One study estimated the economic value of counterfeit goods at approximately 2% of world trade or $176 billion and others have estimated the value as high as $600 billion. This does not take into account the increased health costs resulting from substandard counterfeit drugs or lost tax revenue from the sale of legitimate products. Additionally diverters and grey market products undermine legitimate retailers and distribution channels.
In creating the PASS program, DISC assembled the latest in anti-counterfeiting and authentication technologies for a wide cross-section of industries from pharmaceuticals to fragrances. It is about working together with brand owners to protect their name and the consumers who count on their products. We can provide a layered
approach that will match your brand protection requirements. Most importantly, we’ve incorporated a layer of irrefutable evidence in the form of unique DNA Taggants used to verify authenticity and prosecute counterfeiters. How is P.A.S.S. a different approach to the counterfeiting problem? We see packaging having an active role in brand protection by arming it with technology to deter and defeat counterfeiting. While most printers wait for customers to come knocking before acting, in the PASS program we’ve assembled world-class technology partners to help deliver customized solutions targeting the customers’
authentication and brand protection issues. We started by providing DNA as a blanket protection for all customers, which can be combined with an array of technologies including those listed below:
How is the DNA material made? Botanical DNA is first harvested
Level 1 SigNature DNA Forensic Authentication Marking
The harvested DNA is segmented
SigNature DNA, which is Disc’s exclusive core technology for use in all packaging, takes the uniquely sequenced DNA from plants to mark and authenticate products in a manner that cannot be copied. The DNA mark is a symbol of forensic DNA Segments are shuffled, reassembled and encrypted to form a unique, secure DN protection that indicates irrefutable eviSegments are shuffled, reassemb dence of authenticity. By comparison to Segments are shuffled, reassembled and synthetic DNAs on the market, ours canencrypted to form a unique, secure DNA Segments are shuffled, reassembled and encrypted to form a unique, secure DN not be removed or copied.
The SigNature DNA marker has been validated by national and international agencies. Products from microchips to guitars and currency are being marked with SigNature DNA. This first step can be layered with Level 2 and Level 3 technologies providing a comprehensive approach to brand authentication and security.
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Level Level 2 Device 2 Device Required Required Field Field Authentication Authentication Marking Marking Honeywell Fluorescent pigments are neutral in color and
inks and coatings. Depending on the formula, when irradi pigments emit fluorescent radiation of specific colors such blue and white. The pigments can create a “layered appro colors, and Honeywell can develop a customized system
While DISC includes the DNA marker in all its packaging, customers can license the DNA logo for marketing and on-package brand protection. We’ve developed proFortuna isFluorescent Agfa’s pigments digital Honeywell Honeywell Fluorescent pigments areare neutral neutral in color in color andand areare notnot notic no grams that make licensing scalable and inksdesign inks andand coatings. coatings. Depending Depending on on the the formula, formula, when when irradiated irradiated with with a U and assembly affordable. pigments pigments emit emit fluorescent fluorescent radiation radiation of specific of specific colors colors such such as yellow, as yellow g system for security printblue blue andand white. white. The The pigments pigments cancan create create a “layered a “layered approach” approach” by add by a colors, colors, and and Honeywell Honeywell cancan develop develop a customized a customized system system thatthat includes includ ing. This digital system Fortuna is Agfaʼs digital design and assembly system for differenttomodules generate ofconsists differentofmodules generatetocomplex designs or text, complex designs or text, virtually unnoeye, and is used in such high security markets such as ba with the customerʼs files to create ticeable to the experienced eye,micro and ispatterns or text th are seen by using loop or similar device used in such highasecurity marketsmagnification such as DISC/Applied DNA Sciences Logo that will quickly banknotes and brand protection. We can become the standard for DNA brand authentication 2 Device Required Authentication Level work with the customer’s files Field to create miIdentifiers cro patterns or text that are nearly imposFortuna Fortuna isto Agfaʼs isduplicate Agfaʼs digital digital design design andand assembly assembly system system security security print p sible and are seen by using afor for of different of different modules modules to generate to generate complex complex designs designs or text, or text, virtually virtually unnu Level 2 Device Required Field loop orused similar device. eye, eye, andand is is used in such inmagnification such high high security security markets markets such such as banknotes as banknotes and Level 2 Marking Device Required Field Authentication Marking Authentication withwith thethe customerʼs customerʼs filesfiles to create to create micro micro patterns patterns or text or text thatthat areare nearly ne areare seen seen by using by using a loop a loop or similar or similar magnification magnification device device
Level 2 Device Required Field Authentication Marking and 2 Device 2 Device Required Required Field Field Authentication Authentication Marking Marking a Level Level Level 3 Visible Brand Identifiers Identifiers Identifiers
KURZ security foils products can be used for both Level 2 custom foils that have device required "covert" markings special devices. In addition KURZ foils can provide "overt consumers and supply chain partners authenticate produ apply these specialized foils with in-line cold foil or hot sta KURZ security foils products can be Honeywell Fluorescent pigments are neutral in color and areproducts not noticeable when added to printing KURZ KURZ security security foils foils products cancan be be used used for for both both Level Level 2 and 2 and Level Leve 3 Honeywell pigments areon the formula, custom custom foils foils that that have have device device required required "covert" "covert" markings markings or text or text that tha ca inksFluorescent and coatings. Depending when irradiated with a UV or IR light source, the used for both Level 2 and Level 3 protecneutral in color and are not noticeable special special devices. devices. In addition In as addition KURZ KURZ foilsfoils can can provide provide "overt" "overt" visible visible bran b pigments emit fluorescent radiation of specific colors such yellow, green, orange, red, Turquoise, tion. This includes custom foils that have consumers consumers and and supply supply chain chain partners partners authenticate authenticate products. products. DISC DISC ha blue and white. The pigments can create a “layered approach” by adding both IR and UV reactive when added to printing inks and coatapply apply these these specialized specialized foilsfoils withwith in-line in-line coldcold foil or hot or hot stamping stamping meth m device required “covert” markings orfoil text colors, and can develop ings. Depending onHoneywell the formula, when a customized system that includes a secure reader. that can be read with magnifiers or special irradiated with a UV or IR light source, the devices. In addition KURZ foils can provide pigments emit fluorescent radiation of “overt” visible brand identifiers that help specific colors such as yellow, green, orconsumers and supply chain partners auange, red, turquoise, blue and white. The thenticate products. DISC has the in-house pigments can create a “layered approach” capability to apply these specialized foils by adding both IR and UV reactive colors, with in-line cold foil or hot stamping methand Honeywell can develop a customized ods for both labels and cartons. system that includes a secure reader.
Fortuna is Agfaʼs digital design and assembly system for security printing. This digital system consists of different modules to generate complex designs or text, virtually unnoticeable to the experienced eye, and is used in such high security markets such as banknotes and brand protection. We can work with the customerʼs files to create micro patterns or text that are nearly impossible to duplicate and are seen by using a loop or similar magnification device
Level 3 Visible Brand Identifiers
DISC’s partner company Applied DNA Science can generate and provide a registry of codes, and has a web-based solution for code verification using smart phone applications.
Serialized Codes and Registry Human Readable Codes are alphanumeric codes imprinted on the package that are Level 2 Device Required Field read with the naked eye giving distribuAuthentication tors, retailers and consumers the ability to verify authenticity using an online dataQR Code reader using smart phone base. These codes will comply with reapplication (In Development) cent FDA guidance for securing the Drug QR Codes (abbreviated from Quick Rele Brand Identifiers Supply Chain using Standardized Numerisponse code) are specific machine readcal Identification (SNIs) for prescription able matrix barcodes (or two-dimensional drug packages. QR According to the using FDA, an Code reader smartcodes) phone designed application (In read Development) to be by SmartSNI for most prescription drug packages phones or secure devices. The code patQR Codes (abbreviated from Quick Response code) is a specific machine readable ma should be a serialized National Drug Code tern are on adesigned white background contain barcode (or two-dimensional code) to be read can by Smartphoneʼs or secure (sNDC). The sNDC is composed of the a variety of information including text, a code pattern on a white background can contain a variety of information including text, des and Registry National Drug Code (NDC) (as set forth in other data. Example below: URL, or other data. Example below: le Codes are21 alphanumeric codes on thetopackage that are read with the CFR Part 207) thatimprinted corresponds the g distributors, specific retailers drug and consumers the ability the to verify product (including par- authenticity using an online codes will comply with recent FDA guidance for securing the Drug Supply Chain package configuration) combined ed Numericalticular Identification (SNIs) for prescription drug packages. According to the with drug a unique serialshould number, by most prescription packages be agenerated serialized National Drug Code (sNDC). mposed of thethe National Drug Code (as set for forth in 21 CFR Part 207) that manufacturer or (NDC) re-packager each he specific drug product package. (including the particular package configuration) combined individual rial number, generated by the manufacturer or re-packager for each individual An example is shown below with a 10-character NDC as shown in the March 2010 FDA Guidance forasthe Pharmaceutihown below with a 10-character NDC shown in the March 2010 FDA Guidance for cal Industryii: cal Industry : In a partnership with APDN, product idenIn a partnership with APDN, product identity/profile information serial number information is tity/profile information andand serial number the customerʼs system as well as cloud-based Rapidna-QR system (automated scanning and/o information is entered into the customer’s Specified users such as consumers, retailers or distributors can access information about the p as well as cloud-based Rapidnapedigree, and facilitates track andsystem trace requirements. QR system (automated scanning and/or easy input). Specified users such as consumers, retailers or distributors can access information about the product’s pedigree, ompany Applied DNA Science can generate and provide a registry of codes, and has and the code facilitates track and trace ution for code verification using smart phone applications. requirements.
In a partnership with APDN, product identity/profile information and serial number information is entered into the customerʼs system as well as cloud-based Rapidna-QR system (automated scanning and/or easy input). Specified users such as consumers, retailers or distributors can access information about the productʼs pedigree, and facilitates track and trace requirements.
The scanned code is sent to a “cloud based” secure server that verifies the data and communicates back to the device for authentication
The scannedthis codesolution is sent to a is “cloud based” secure server that verifies the data and designed to Remember under development and is uniquely communicates back to the device for authentication customer specifications
Remember this solution is under development and is uniquely designed to customer specifications
PACKAGE AUTHENTICATION SECURITY SOLUTIONS
PACKAGE AUTHENTICATION SECURITY SOLUTIONS United Nations Office of Drugs and Crime. (2010). The globalization of crime: A transnational organized crime threat assessment. Retrieved from www.unodc.org: www.inodc.org/documents/data-and-analysis/tocta/8.Countfeit_products.pdf
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FDA (March, 2010). Guidance for Industry Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages. Retrieved March 30, 2010 from http://www.fda.gov/RegulatoryInformation/Guidances/ucm125505.htm
GLOSSARY ADR Authorized Distributor of Record: a distributor who has an ongoing, written, and direct business relationship with the original manufacturer (and thus generally receives the product directly from the factory). Alphanumeric code Human-readable
code format that may contain both letters (A-Z) and numbers (0-9). The increased number of permutations therefore allows data to be encoded with fewer characters than if only numbers are used.
Anti-counterfeiting technologies
Technical measures designed to prevent or detect counterfeiting. Not synonymous with “track and trace technologies” which may be for purely logistical purposes (codes on mail items, for example).
Authentication The process of proving that packaging, product, or other item is (or is not) genuine. Generally divided into digital authentication (codes, database, transaction history, etc.) and sensory authentication (holograms, inks, taggants, etc). Bi-flourescent An ink that fluoresces at two
CMO Contract Manufacturing Organization. Colorshift ink An ink that reflects light at two different wavelengths depending on the angle of view, with a characteristic “flip-flop” effect when the substrate is tilted. Not to be confused with iridescent inks.
Compliance An older term for Adherence. Compliance-prompting packaging
Packaging design that encourages the patient to “comply” with their medication regime. Such packs often include prompts and design features, which make it easier for the patient to take their medication in the correct dosage or combination and at the correct time.
Counterfeit The definition of a counterfeit
drug is controversial, encompassing intellectual property issues, substandard drugs, unauthorized generics, etc; in general, the functional definition of a counterfeit used in this book is a product made with the intent to deceive, by misrepresenting it as something it is not.
different wavelengths.
Blister foil Aluminum foil used to seal pills or capsules into a blister pack.
Blister pack In the pharmaceutical context, almost always a plastic or laminate tray with separate wells for each pill or capsule, sealed with blister foil. Bookend system A term used to describe a pharmaceutical tracking approach with (usually) only two main points of control, at the beginning and end of the supply chain (like bookends holding books on a shelf). Developed as a pragmatic solution to implementing tracking in a complex multi-stakeholder distribution environment. Closure seal A means of sealing a pack to prevent accidental opening. For anti-counterfeiting purposes, closure seals need to be tamperevident and secure, or they can be easily replaced.
Covert Hidden or concealed, not visible to the naked eye. A covert feature can only be seen with specific equipment. A distinction is sometimes made between “semi-covert” features, which can be viewed with low-cost devices such as filters or lamps and “covert” features, which require such a more sophisticated reader or laboratory instrument. Diffractive optically variable image device (DOVID) A feature that diffracts light, creating images that vary according to the viewing angle. These effects can be three-dimensional or appear to move. Holograms are DOVIDs but not all DOVIDs are holograms. DOVIDs have been widely used in pharmaceutical packaging, often in the form of a label or seal.
Diversion The sale of genuine goods outside
the authorized supply chain. Diversion and parallel trade are sometimes used synonymously but they are different. Diversion is usually taken to refer to illegal trade or commercial activity that breaks the terms of a commercial arrangement or donation. Diversion often occurs in conjunction with counterfeiting.
DNA (deoxyribonucleic acid) is a
double-stranded molecule that is twisted into a helix like a spiral staircase that contains the genetic instructions used in the development and functioning of all living organisms. Each strand is comprised of a sugar-phosphate backbone and numerous base chemicals attached in pairs. The four bases that make up the steps in the spiraling staircase are adenine (A), thymine (T), cytosine (C), and guanine (G). It is the sequence of these four nucleo-bases along the backbone that encodes information. This information is read using the genetic code, which specifies the sequence of the amino acids within proteins. The code is read by copying stretches of DNA into the related nucleic acid RNA in a process called transcription.
DNA sequencing includes several methods and technologies that are used for determining the order of the nucleotide bases in a molecule of DNA. Knowledge of DNA sequences has become indispensable for basic biological research, other research branches utilizing DNA sequencing, and in numerous applied fields such as diagnostic, biotechnology, forensic biology and biological systematics.
EMA (formerly EMEA) European Medi-
cines Agency, formerly the European Medicines Evaluation Agency. The principal drug regulatory body for the 27 members of the European Union.
EPC Electronic Product Code. A data standard for the unique identification of any item around the world.
EPCglobal The organization, which administers the Electronic Product Code systems and coordinates the development of the associated data standards. EPCIS Electronic Product Code Information Service. A data standard used to track the progress of coded objects as they move through the supply chain. EPCIS provides the standards necessary for the storage.
E-pedigree An electronic history of all the movements and transactions involving an individual pack, from manufacturing to patient. Differs from bookend systems in that all intermediate steps are recorded. FDA United States Food and Drug Administration. Fingerprinting In the pharmaceutical con-
text, this is the analysis of randomly distributed physical features on a particular area of the product or its packaging to generate a unique data file for that pack or item. The random features may be either naturally present (surface roughness) or added (bubbles, etc.). By reference to the original database, the fingerprint of an item allows it to be checked and unambiguously identified.
Flourescence Absorption of light of one
wavelength and emission at a different wavelength.
Flourescent Inks Usually, this refers to inks that absorb UV light and emit visible light. The effect is instantaneous and stops when the light source is removed (cf photochromic inks).
Forensic Markers Substances present in the product or its packaging, which cannot be visualized by the eye or using simple tools or readers. The presence of a covert forensic marker is designed to provide litigation-grade proof of authenticity or conversely to demonstrate beyond doubt that a suspect sample is counterfeit. Generally, the term is reserved for those technologies that require complex, often laboratory-based analysis.
Form-fill-seal The process whereby the packaging is manufactured, filled with pharmaceutical product, and sealed in a single integrated process. The term is most commonly used for blister packs and related forms. Blow-fill-seal is a related term more commonly used for bottles and vials.
Infrared (IR) Light with a longer wavelength
GMP Good Manufacturing Practice. Legally enforceable process and quality requirements for the manufacture of drugs. GMP helps ensure consistency in manufacturing. Any process, which is added to the pharmaceutical production line (such as serialization, etc.) must therefore be compatible with GMP. Sometimes known as cGMP or current Good Manufacturing Practice.
Iridescent Materials that reflect visible light
GRAS An abbreviation used by the US FDA meaning “Generally Regarded as Safe” and which refers to substances that have an accepted safety profile. GTIN Global Trade Item Number. A GSI standard
number unique to each stock keeping unit (SKU) or specific product type but not unique to the individual pack itself (see SGTIN).
Hologram An optically variable image created through light interference. Commonly used in pharmaceutical packaging and for decorative and packaging applications in other industries. There is wide variation in the visual effect and security value of holograms, which are a type of DOVID. Induction seal An aluminum foil or paper
seal bonded over the opening of (usually) bottles after they have been filled with pills or capsules. Provides tamper-evidence but can potentially be illegally replaced if plain foils with no security features are used on the original product.
IIG Inactive Ingredients Guide. An FDA database of excipients and formulation components that are not known to have any significant positive or negative pharmacological effects on humans.
than visible light, in the region of the electromagnetic spectrum between visible light and microwaves. Used for various types of detector. Most analytical IR instruments use near infrared radiation, the most energetic (high frequency) form.
at multiple wavelengths simultaneously to give multi-colored or rainbow effects. Iridescent inks are sometimes used as lowgrade security features. They are not the same as colorshift inks.
Laser Ablation A marking technique used
to add small amounts of variable data to cartons or labels. The effect is usually achieved by using a laser to selectively burn off the ink from a preprinted black area. The data therefore appears as white lettering on a black background.
Laser Engraving The direct etching of data onto or into a surface (usually glass) using a laser.
Layering The use of multiple security technologies (“layers”) on the same product, to increase the level of protection against counterfeiting. Meditag A serialized hologram system used to authenticate drugs in Malaysia. Microparticles Micron-scale (one millionth
of a meter) security markers. They are not visible to the naked eye but can be seen with a low-powered microscope. Often incorporated into security inks or other applied features.
Microprint Security printing features that require magnification in order to be visualized. They are generally too small to be reproduced by photocopying or scanning and therefore provide some protection from unsophisticated copies. Nanoparticles Nanometer-scale (one bil-
lionth of meter) forensic markers. Cannot be seen with a low powered microscope and require an electron microscope to be visualized.
NDC National Drug Code. The legally required number format for all pharmaceuticals sold in the United States. The eventual serialization of drugs in the United States with unique pack numbers will use a numbering system based on serialized NDC (sNDC). Overt Visible to the naked eye without addi-
tional tools or readers. Overt security features on pharmaceutical products are generally aimed at the general public. The same feature, printed or applied in one step, may contain multiple overt and covert aspects.
Pedigree A history of all of the movements and transactions involving an individual pack, from manufacturer to patient. Pedigrees may be paper based or electronic (see e-pedigree). Required (or soon to be required) by law in some jurisdictions (notably California). Photochromic inks Inks which change color when exposed to UV light and only revert to the original appearance a few seconds or minutes after the UV source is removed. Compare with flourescent inks that revert immediately. Polarizing inks Inks which reflect incident, randomly oriented (non-polarized) light waves at a specific (polarized) angle or which change the angle of an incandescent beam or polarized light. These inks can be visualized with inexpensive filters and are an example of a semi-covert technology. The polarizing feature may be translucent or part of a second overt feature. Primary packaging The first layer of packaging around the dosage form. This may be a bottle, blister pack, vial, inhaler, etc.
Randomization The use of randomly generated (rather than sequential) number elements in a serialization scheme to prevent prediction of the subsequent numbers in sequence.
RFID Radio frequency identification. A tracking technology that uses radio waves received and transmitted by small tags or labels containing a microchip and antenna. At the time of writing (2010), the technology is generally considered still too expensive for most unit pack applications but is commonly used for higher level packaging (pallets, cases, etc.). The technology has the major advantage that it does not require line of sight, so RFID tags can be read through packaging. Secondary Packaging Additional packaging layer(s) used to protect the dosage form and the primary packaging from damage in transit, to aid in efficient packing into shipping cartons and to allow the incorporation of other items such as patient information leaflets. Semi-covert Security features that are not visible to the naked eye but that can be visualized with commonly available devices such as magnifying lenses and polarized filters and do not require sophisticated machinery or laboratory analysis. Serialization Commonly used to mean the
process of identifying and tracking items at the unit level, using a number specific to each unit pack and unique worldwide. Various number formats exist, although most of the proposed or implemented systems use variants of the GSI system. In the United States, the format for a Standardized numerical identifier has been stipulated by FDA and is based on the existing NDC system. The number used for serialization may be printed as an alphanumeric code or a data matrix or encoded on an RDIF chip.
SGTIN Serialized Global Trade Item Number. Addition of a serial number to the GTIN format enables unique identification of individual packs anywhere in the world. SKU Stock-keeping unit. Each unique inventory item type (e.g., “Ingesta 20 mg, 30 capsules�) will have an identifying SKU number (or alphanumeric code), which is often also printed as a linear bar code. SKU data gives no information about batch number or individual pack identity.
sNDC Serialized National Drug Code. An ex-
tension of the existing NDC system to enable the unique identification of individual unit packs. The sNDC is a GSI-compatible system and was adopted as a standardizes numerical identifier (SNI) for all drugs in the United States by the FDA in 2010.
SNI Standardized Numerical Identifier. The data structure chosen by FDA, as part of the implementation of the FDA Amendments Act (FDAAA), to allow all pharmaceuticals to be tracked at item level. Taggant
Often used synonymously with forensic markers, this term describes a covert feature which is difficult to find without prior knowledge and appropriate equipment. Taggants come in may forms and are detected, either with specialist readers or laboratory equipment, on the basis of specific and unique and/or physical properties.
Tamper-evident Closure devices or sealing
features that can be opened easily without special tools but that are designed for one-time use. Breakage of the seal thus demonstrates that the packaging has been opened and the product may have been tampered with, refilled, or replaced.
Tamper-resistant A packaging feature that
discourages casual opening or tampering but is designed to resist a determined attempt to open it.
Tamper-proof A packaging design or closure that cannot be opened without force or the use of special equipment and tools.
Thermochromic ink Ink that changes color
(reversibly or irreversibly) when heat is applied. The heat may be in the form of thumb pressure, for example, allowing the ink to be used as an authentication feature. Alternatively, the ink may change color irreversibly above a certain temperature to act as an alert when cold chain conditions have been breached.
Track and trace The process of recording data as an item moves through the supply chain. The level and frequency of data recording varies between systems. Tracking is the routine following of a product or consignment as it moves from producer to customer. Tracing is used to find an item or batch in the event of a recall or to identify a product’s history in the event of a counterfeiting incident. UV Ultraviolet light. Voiding The process whereby the removal of
an adhesive label leaves behind a colored or detectable residue, usually spelling out a word. This is a useful tamper-evident feature.