3. available models general overview on existing...
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1 Universidad de Belgrano – Medicine Traceability Overview – 18 Majo, 2010
3. Available ModelsGeneral Overview on Existing IdentificationTecniques & Models
2 2010 – rev. 00Universidad de Belgrano – Medicine Traceability Overview – 18 Majo, 2010
3 2010 – rev. 00Universidad de Belgrano – Medicine Traceability Overview – 18 Majo, 2010
POINT OF ENTRYMANUFACTURE DISTRIBUTOR POINT OF EXIT
RETAIL PHARMACYWHOLESALE
Actual Supply Chain :
DATA DATA DATA DATA
PROBLEMS?
PATIENT
DATA
4 2010 – rev. 00Universidad de Belgrano – Medicine Traceability Overview – 18 Majo, 2010
PharmacyManufacturer
Carton 1234
DistributionChain
Carton 1234
1) A Potential Solution: Autentiction/ SerializationA Univoque and NON-Predictive series of Characters has to be printed on the BOX at the manufacturing site, and verified at the subministration&/or sales pointA safe connection to a Unique reference Database verify the correlation between the two numbers, so can authenticate each single boxThe Pharmacist can check the AUTHENTICITY of each single box connecting the Vendor’s DB
5 2010 – rev. 00Universidad de Belgrano – Medicine Traceability Overview – 18 Majo, 2010
A Univoque and NON-Predictive series of Characters has to be printed on the BOX at the manufacturing site, with a second code in addition (possibly hidden), or any additional safe measure (special inks, etc.)
The additional element is not verified at the distribution or at the sales point, but it’s used by the vendor or by the distributor as an additional Autenticity confirmation
2) A Potential Solution: Security / Layering
Covert Code ABC Covert Code ABC
PharmacyManufacturer
Carton 1234
DistributionChain
Carton 1234
6 2010 – rev. 00Universidad de Belgrano – Medicine Traceability Overview – 18 Majo, 2010
Manufacturer
Carton 1234 Pallet K6J7Case ABCD
Codes are related eachother
Univoque and NON-Predictive series of Characters printed at each Packaging LineThe code are related eachother either with specific “Generation Procedures” and/or either some “aggregation/grouping” procedures during Production Even if this solution has some validity inside the plant, it could even use by authentication Process by the Pharmacist
3) A Potential Solution: GROUPING (Aggregation)
7 2010 – rev. 00Universidad de Belgrano – Medicine Traceability Overview – 18 Majo, 2010
PharmacyManufacturer
Wholesaler A Wholesaler B
Shipment JHKL Shipment JHKL Shipment JHKLShipment JHKL
A Unique Code identify the smallest unit of the product, and will be RECORDED at any steps of the supply chain to the distribution/sales pointThe ELECTRONIC PEDEGREE allows each supply chain component to trace all steps to the manufaturing plantThis solution could be implemented together with other Grouping or Identification Tecniques
4) A Potential Solution: ELECTRONIC PEDEGREE
8 2010 – rev. 00Universidad de Belgrano – Medicine Traceability Overview – 18 Majo, 2010
A Unique Identification Number will trace medicines throught alla the Supply Chain in REAL TIMEThis is the most complex scenario, ‘cause of requires the active involvment of each steps/location with a unique centralized DatabaseCoul be implemented together with e-Pedigree
DB
PharmacyManufacturer Wholesaler A Wholesaler B
Shipment JHKL Shipment JHKL Shipment JHKLShipment JHKL
5) TRACK & TRACE
9 Universidad de Belgrano – Medicine Traceability Overview – 18 Majo, 2010
2. Identification Tecniques
Data Collection and Identification needs & Techniques
10 2010 – rev. 00Universidad de Belgrano – Medicine Traceability Overview – 18 Majo, 2010
Product Identification means a readable graphic/electronic sequence of character (code) which can be Individually recognize and collectedHuman reading is:
ExpensiveImpreciseTime ConsumingSubject to the Human… Not adequate for industrial use
11 2010 – rev. 00Universidad de Belgrano – Medicine Traceability Overview – 18 Majo, 2010
Refers to the methods of automatically identifying objects, collecting data about them, and entering that data directly into computer systems - with/witout human involvement
Technologies typically considered as part of AIDC include bar codes, Radio Frequency Identification (RFID), biometrics, magnetic stripes, Optical Character Recognition (OCR), smart cards, and voice recognition.
AIDC is also commonly referred to as “Automatic Identification,” “Auto-ID,” and "Automatic Data Capture.
12 2010 – rev. 00Universidad de Belgrano – Medicine Traceability Overview – 18 Majo, 2010
13 2010 – rev. 00Universidad de Belgrano – Medicine Traceability Overview – 18 Majo, 2010
Barcode could be Printed and apply using different “office” and Industrial Techniques and support:
DOT PrintersStandard Laser PrintersContinuous Inkjet (CIJ)Piezo Drop on Demand inkjet (DOD)Thermal Drop on DemandScribing LaserDirect Thermal Thermal Transfer Over printer (TTO)Industrial Laser Plotter (for metallic surface)Print & Apply
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Dedicated Standard – Software Driven
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Hand Held Industrial
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ISO/IEC 15961 ISO/IEC 18000ISO/IEC 15962 ISO/IEC 15962Annexes
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Hand Held Industrial
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ACTVIVE RFID Passive RFID
Tag Power Source Internal TAG Energy Transferred Using RF from reader
Tag Battery YES NO
Availability of Power Continuous Only in field form READER
Required Signal Strength to TAG Low High
Range More than 50 mt 3 TO 5 Mt, usually less
Multi Tag Reading 1000 TAGS recognised (at high speed)
Few hundreds TAGs within 3 mt
Data Storage 128 KB R/W 128B R/W
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There are different identification technology; however the most used are:
Barcode & “Printed Simbology”
RFID
OPTICAL TECHNOLOGYUse a “readable symbol” and a ReaderDifferent Symbology can be used for different type of codingThe CODE itself is printed once and it’s PASSIVE
Radio Frequency TECHNOLOGYUse a Chip (TAG) and a Reader (Antenna)Different sequence of data can be recorded into the chip memoryTAGs could be Passive or Active
21 2010 – rev. 00Universidad de Belgrano – Medicine Traceability Overview – 18 Majo, 2010
Economic Support (Label)Barcode Rader and 2D Reader are standard product (even portable)Barcode reader has standard PC Connection(Keyboard emulation, Serial, USB)Multiple readingReading AccuracyEasy to Produce on demand / on lineOptical ReadingPrint only onceNeed Physycal/direct ContactLess flexible in Time
More Expensive Support (Label)Dedicated Device Multiple ReadingReading AccuracyIntegration with other sensorsTAGs could be modifiedDoesn’t need Physycal/Direct ContactMore flexible in time (re-use of label/support)
Universidad de Belgrano – Medicine Traceability Overview – 18 Majo, 201022 Rev. 1.0
SHIP TO: SHIP FROM:
COMMANDING OFFICER DDSP SUSQUEHANNA, PA 15230
CHEMICAL SUPPLIER CHEMICAL COMPANY INSTITUTE, WV 23456
TCN:
NSN:
CAGE:
MSDS #:
GTIN:
HCC:
AHRIST DATA:
AWHGEAA$0F00090XX
5310011987585
AWHGE 00098756100013CHEM WT:
ABCDE 10000A1
23 2010 – rev. 00Universidad de Belgrano – Medicine Traceability Overview – 18 Majo, 2010
Bill of LadingMaterial Tracking
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Operazioni di lettura/scrittuaMaggiore accuratezza del bar-code
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WirelessBatch
Fixed Station
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Wireless / BatchGestione Inventario
Movimentazione materiale
Movimentazione materialeIspezione
Movimetnazione materialeAggregazione / Disaggregazione
Dov’è? Cos’è? Cosa c’è dentro la scatola?Dove va? Da dove viene? E’ giusto che sia qui?
Cosa ho riunito? Quanti pezzi ho? Come è composto il pallet?
27 2010 – rev. 00Universidad de Belgrano – Medicine Traceability Overview – 18 Majo, 2010