Manufacturing Intelligence: Serialization to Improve Processes. Presented By Jean Pierre Allard Serialization Product Manager Optel Vision

Transcription

1 Manufacturing Intelligence: Serialization to Improve Processes Presented By Jean Pierre Allard Serialization Product Manager Optel Vision

2 INTRODUCTION

3 Agenda Standards Overview General Solution Architecture Bottle Association Bottle or Carton Aggregation Carton Case Packer Aggregation Label Artwork IT Implementation Validation Strategies Worldwide Regulations

4 What is Serialization? Serialization is the assignment and application of a unique, verifiable product identifier to an individual pack of drug products. Simply put, it is the application of a serial number to any item.

5 Different Mediums are Available for Serialization 1D bar code (01) (21) D bar code GTIN SN Human readable RFID tag

6 What is Aggregation? Aggregation is the association of uniquely serialized packs to a higher packaging level also having an unique serial number. Example: 6 bottles are packed in the same bundle, in serialization words it means that 6 children were aggregated to a parent.

7 Complete Serialization Demonstration Videos (cartons)

8 What is Track & Trace? Track Concerns a process of determining the current and past locations (and other information) of a unique item or property Trace Past history of the item or property

9 Alternative to Track & Trace Serialization with centralized Database

10 Serialization vs. Track & Trace Business Operations Serialization Track & Trace Product Serialization Aggregation Captured Serial Number Captured when shipped Serial Number Captured when received Verification at Point of Dispense Problem to Solve Serialization Track & Trace Counterfeit Products Reimbursement Fraud Stolen Products Ineffective Recalls No Inventory Visibility Through Supply Chain

11 STANDARDS OVERVIEW

12 GTIN, is a Product Identifier Valid and Unique Globally US Regional Standard NDC: Country Prefix Labeler Product Package Packaging Level 0=Carton 2=Case, Code Code Code Verification GTIN: Indicator Company Product Check Digit Prefix Code Digit

13 NTIN is a National Product Identifier 0 German PZN to NTIN Conversion

14 Source Global Acceptability of GTIN

15 GTIN and a Serial Number is the True Unique Item Identifier GTIN number is static for a given product Same GTIN Serial Number changes for every individual item produced Different Serial Number

16 GS1 has defined a clear structure GS1 standard code is made of Application Identifiers (AI) Code can be formatted in 2D or 1D bar code GTIN AI GTIN- 14 S/N AI S/N (01) (21) (01) (21) (01) (21)

17 GS1 has defined more than 90 Application Identifiers AI Description Data Format 00 Serial Shipping Container Code(SSCC-18) 18 digits - numeric 01 Shipping Container Code (SSC) 14 digits - numeric 02 Number of containers 14 digits - numeric 10 Batch Number 1-20 alphanumeric 11 Production Date 6 digits: YYMMDD 13 Packaging Date 6 digits: YYMMDD 15 Sell by Date (Quality Control) 6 digits: YYMMDD 17 Expiration Date 6 digits: YYMMDD 20 Product Variant 2 digits 21 Serial Number 1-20 alphanumeric Several Application Identifiers are available. Using this standard, and there is no need to communicate to other partners howtoreadyourcode. 22 HIBCC Quantity, Date, Batch and Link 1-29 alphanumeric 23x Lot Number 1-19 alphanumeric 240 Additional Product Identification 1-30 alphanumeric 250 Second Serial Number 1-30 alphanumeric 30 Quantity Each - 310y Product Net Weight in kg 6 digits 311y Product Length/1st Dimension, in meters 6 digits 312y 313y Product Width/Diameter/2nd Dimension, in meters Product Depth/Thickness/3rd Dimension, in meters 6 digits 6 digits

18 WORLDWIDE REGULATIONS

19 Latest Legislations Summary Country Item Level Serialization Serialization and Aggregation Standard Carrier Turkey D barcode India 2011 to D barcode China Custom System 1D barcode California (USA) Any Europe Possibly TBD

20 GENERAL SOLUTION ARCHITECTURE

21 Bottle Packaging Line Ready for Track & Trace Bundle Label Print & Inspection Manual Aggregation Station Bottle Inspection and Association Pre-Aggregation Bundle Content Inspection Post-Aggregation

22 BOTTLE ASSOCIATION

23 Bottle Association Station HMI 360 Station + Top Code Inspection Label Inspection

24 What is a Tracking Code? Temporary number Can be a simple incremental code Does not need to have a wide range (can be from 0 to ) Associated with the label serial number Read after aggregation Tracking Code Serial Number Tracking Code Serial Number

25 Bottle Post-Aggregation Inspection Requires an Accessible Tracking Code A Tracking Code to Capture all bottles once packed in bundle or case Allow any operator intervention prior or inside the packing station

26 How and Where to Apply a Tracking Code on a Bottle? Pre-printed on topsert (UV or visible) On-line printing on cap (UV - invisible) On-line printing on cap (UV or visible)

27 Complete Serialization Demonstration Videos (bottles)

28 Bottle Association and Commissioning Station 360 Station + Top Code Inspection

29 Videos - Real Use Case for Bottle Association (360 )

30 CartonTracker Inspection Station Typical unit ensure Carton Stabilization Increase Print Quality Minimum line changes Benefits from Reduced reject due to poor print Increase quality Mobility Cost saving Simplified validation

31 Videos -Real Use Case of Commissioning

32 Videos -Real Use Case of Commissioning

33 BOTTLE OR CARTON AGGREGATION

34 What is Aggregation? Aggregation is the association of uniquely serialized packs to a higher packaging level also having its unique serial number. Example: 6 bottles are packed in the same case in serialization words, it means that 6 children were aggregated to a parent.

35 Videos -Real Use Case of Automatic Aggregation

36 Videos -Real Use Case for Manual Packing

37 Videos -Real Use Case of Manual Packing

38 CARTON CASE PACKER AGGREGATION

39 Option A: Layer by Layer Inspection

40 Option A: Layer by Layer Inspection

41 Option B: Row by Row Inspection

42 Option C: Carton by Carton Inspection

43 LABEL ARTWORK

44 Label Layout Consideration Labels for serialized products need to be modified to accommodate new information

45 Minimal Blank Area Size for California 8mm 7.2mm Data Matrix 18x18 (0.4mm/module) with the following code: <fnc1> LOT EXP SN mm FONT: OCR B (Size 6) 26.5mm Zone for Print Instability ±??mm (Application Related)

46 Minimal Blank Area Size for Europe, Turkey, India Data Matrix 22x22 (0.4mm/module) 8.8mm <fnc1> <fnc1> mm GTIN LOT EXP SN mm FONT: OCR B (Size 6) 35mm Zone for Print Instability ±??mm (Application Related)

47 12mm Minimal Blank Area Size for Europe, Turkey, India 8.8mm Data Matrix 22x22 (0.4mm/module) <fnc1> <fnc1> LOT EXP SN GTIN mm FONT: OCR B (Size 6) 29mm Zone for Print Instability ±??mm (Application Related)

48 Case Label as Recommended by HDMA

49 IT IMPLEMENTATION

50 Serialization Plant Server Role Serial Number Provider Serialization Data (EPCIS Repository) IT Solution Platform Government Agencies Connectors to External Entities Packaging Line Warehouse & DC Distribution Partners

51 EPCIS Allows Serialization Data Transfer Between Different IT Platforms MANUFACTURER DISTRIBUTION WHOLESALER

52 EPCIS Event Recorded Information WHO Ship-From, Ship-To WHAT Products S/N, Disposition, Relationships WHERE Locations, Warehouses, Rooms WHEN Time, Date WHY Commissioned, Packed, Shipped, Received

53 Typical IT Architecture Corporate Track&Trace Server Serial Number Provider EPCIS Repository ERP & Domain Controller Option A Direct Link to Corporate Serial Number Manager Plant T&T Server EPCIS Repository PharmaProof LineMaster Option B PlantServer PharmaProof Vision Control & Ejection All Printers Scanner

54 Typical IT architecture with a Contract Packer Customer A - IT Solution Customer B - IT Solution Serial Number Provider EPCIS Repository Serial Number Provider EPCIS Repository Plant T&T Server ERP & Domain Controller Serial Number Manager EPCIS Repository LineMaster PharmaProof PharmaProof Vision Control & Ejection All Printers Scanner

55 Line Start-up is now more efficient Process Order scanned on LineMaster Color Code User Machine Batch Attributes (Lot, Exp, Materials ID) pulled from ERP Batch is authorized on LineMaster Layouts are sent To the Coders Configuration sent to PharmaProof Build Reference on PharmaProof Line Controllers Ready for Batch

56 Serial Number Management Step 1 Product A has never been serialized Max 100K Line Step 2 Serial Numbers are requested to a quantity corresponding to Max Min 50K Product A Serial Number Cache Serial Number Provider

57 Serial Number Management Step 3 Numbers are being used to print on labels for Product A Step 4 The same product A must be packed on a different Line Max 100K Min 50K Line Product A Serial Number Cache Max 100K Min 50K Line Product A Serial Number Cache Serial Number Provider

58 Serial Number Management Step 5 The serial number cache for Line 1 reaches the minimal threshold Step 6 Serial Number cache is refilled to Max for Line 1 Max 100K Min 50K Line Product A Serial Number Cache Serial Number Provider Max 100K Min 50K Line Product A Serial Number Cache

59 Timestamps Leads the Way to Various Batch Production Reports Reconciliation Reports Performance Reports Statistical Analysis

60 VALIDATION STRATEGIES

61 Validation Process Customer Optel Vision URS PQ TM 5 FS 1 OQ 4 DS 2 IQ 3

62 Packaging Line Systems Validation More work must be performed for Non-Serialized and Serialized Use Cases Label Layouts are now managed by the Vision System Serial Number Uniqueness must be guaranteed New verifications required for Every single event that is time stamped and logged Various connections with the IT

63 Plant Server and IT Validation New Realities must be considered User Name and Password are now centralized Process Orders are transferred to the Packaging Lines Connection with Time Synchronization Server Anti-Virus computer protection

64 CONCLUSION

65 What Makes a Serialization Project Successful? Final results must be considered Validation and integration duration Line setup time Maintain the line efficiency Rework operations Aggregation inspection risk Plan ahead of time Plan label or carton artwork Prepare a good strategy

66 Bring the Right Team Together, from the Beginning Project manager (internal) Validation Packaging line engineer Line Operator IT Label control Logistics (warehouse)

67 Thank you For more information, please visit us in booth #1318 For more information Visit