SE09 Track & Trace Solutions Jeff Bredemus Werner Electric
Related Topics SE02 Balluff RFID SE03 Benefits of Image Based Barcode Reading SE08 Vision Solutions for the Food Ind. Solution Area 5 (Motion & Mechatronics)
Agenda Market Drivers Business Needs FDA Regulations Compliance Dates Pharmaceutical vs. Medical Device Cognex Track & Trace Solutions Balluff Track & Trace Solutions Q&A
Business Drivers ENSURING COMPLYING PROTECTING Patient Safety With Regulations Brand Reputation TRACING Through Supply Chain
Regulations Pharmaceutical & Medical Device 21 CFR Part 801 (1990) 21 CFR Part 11 (1997) GAMP V (2008) DQSA/DSCSA (2013) UDI (2014) epedigree (2015) FDA Public Law 113-54 Initiatives *Drug Quality & Security Act DQSA Drug Supply Chain Security Act DSCSA FDA Public Law 110-85 Sec 226 Unique Device Identification - UDI
Track & Trace, epedigree, Serialization Product/Batch ID Pharm - per product Medical - product and batch code Medical Instruments Diagnostics & Test Kits Pharmaceuticals Rx Drugs and OTC Medicines Delivery Devices Patient Safety #1 Anti-Counterfeiting Recall Effectiveness Product Diversion Vitamins & Supplements Cosmetics
Recall Effectiveness Product Retrieval Identification & removal Notification Patients, regulators and distributors Data Collection I.T. Infrastructure
Global Pharma Packaging Lines Serialization Lines ( ~5700 * ) India, 314 R.O.W, 298 China, 412 Japan, 513 Europe, 1485 North America, 2733 Retrofit (70%) Packaging Plants 5700 lines New Lines (30%) * 2011 Cognex Market Survey
Source: 2014 Stericycle ExpertSOLUTIONS TM, www.stericycleexpertsolutions.com Interesting Data
Source: 2014 Stericycle ExpertSOLUTIONS TM, www.stericycleexpertsolutions.com Interesting Data
Global Standardization Amerinet today affirmed its commitment to adopt and continue to implement GS1 healthcare standards with a focus on driving costs out of the supply chain. The Premier healthcare alliance today became the first Group Purchasing Organization (GPO) to announce it s endorsement of GS1 supply chain standards [for] medical device manufacturers There is a clear advantage in using the GS1 standards and VHA recommends that the FDA allow only GS1 standards as the single mandatory solution for Unique Device Identification.
GS1 Standards in Healthcare
DQSA Implementation Timeline 2014 FDA publishes additional guidance and requirements Nov. 2017 Nov. 2018 Manufacturers affix serialized information on unit level packaging and homogenous cases Implement verification system Repackagers affix serialized information to packages and cases Implement verification system Nov. 2019 Distributors must verify all suspect product using serialized information Nov. 2020 Dispensers must verify 10% of suspect product at lot level Nov. 2023 All segments must use serial numbers and transfer data in secure manner Most Pharma companies will pilot fully functioning lines two years before mandate (i.e. 2015)
UDI Implementation Timeline Sept. 2014 Class III devices must carry UDI Label on labels and packaging Sept 2015 Implantable, life-saving, and life-sustaining Class I & II devices must carry UDI on labels and packaging Sept 2016 Class II device must carry a UDI on labels and packaging Class III devices that require DPM must carry permanent UDI on device Sept 2018 Class I devices must carry UDI on labels / packaging Class II devices that require DPM must carry UDI on device Sept 2020 Class I devices that require DPM must carry permanent UDI on device The time to implement in now!
What s Your Game Plan? Wait and See Analysis paralysis? Budget for next year? Hope for the best? Act Now Interview/select vendors! Develop IT plan! Build Pilot Line!
Options for Implementation Cognex Track and Trace Balluff Traceability
Cognex In-Sight Track & Trace
100% Data Validation Reads and Validates GS1 Data Matrix (2D) and linear barcodes (1D) Validates data using GS1 Application Identifiers GTIN (01) Batch / Lot (10) Expiration date (17) Production date (11) Best Before date (15) Serial Number (21) Price (390) Validates GS1 data to printed text on label (OCV) Grades Data Matrix code marking process online to trigger preventative maintenance
Typical Serialization Line Off-Line Data Matrix Quality Verification Read Pallet Code Read Carton Code Grade Code Verify Printed Text Read Codes in Bundle Read Bundle Code Read Case Code Print Carton Code And Human Readable Data Print Bundle Code Print Case Code Print Pallet Code
In-Sight Track & Trace Off-the-shelf Job File for In-Sight Vision Systems No programming required Easy to use Step-by-step setup Optimized for Serialization Applications Uses GS1 industry standard Simplifies Validation Procedures User access control Parameter change, user & event logging Offer FS/DS & IQ/OQ Templates
Barcode Setup Screen
OCR Setup Screen
Verification Setup Screen Compare 2D data matrix with human readable text with OCR tools.
Communication Setup Screen
GAMP V Product Categories 1 Infrastructure 2 Firmware User Requirement Specification Functional Specification Verification Performance Qualification Operational Qualification 3 Non-Configured Systems Design Specification Installation Qualification 4 Configured Systems 5 Custom Applications System Development
In-Sight Hardware Compatibility Full range of hardware solutions In-Sight Micro Series In-Sight 7000/5000 Series In-Sight 5000 Series In-Sight ID Readers Dataman VGA to 5mpixel Greyscale & color 1x 20x performance
IQ / OQ Validation Documentation
Audit Server Electronic Records Camera boot-up Online/Offline events Login events Job changes Parameter changes
In-Sight Track & Trace Architecture Enterprise-level ERP System (SAP, Oracle) Out to Logistics / Supply Chain Partners Plant-level User Authentication Manufacturing Execution System Serialization System Part 11 Compliance Database Line-level Line Management Software Cognex HMI Display Audit Message Server Track & Trace Machine-level VisionView In-Sight Track & Trace
Balluff Traceability:
Plant Functions requiring Traceability: Asset Tracking plant-based assets Electronic Kanban plant-based material flow Production control (WIP) assembly processes Intra Logistic material flow between plants
Key ROI Elements Asset Tracking Increase asset utilization Ensure correct asset is used Increase overall asset productivity Reduce asset losses Reduce asset's nonproductive time
Commonly Tracked Assets: Machine tools: Offset measurements (from presetter), setup parameters, usage, and tool pocket matching.
Commonly Tracked Assets: Molds and dies: Set-up parameters, usage, maintenance, and part matching.
Commonly Tracked Assets: Totes/containers: Contents, location, usage, and part matching.
Trick is getting the Tag on the Asset Custom tags are common practice
Plant Functions requiring Traceability: Asset Tracking plant-based assets Electronic Kanban plant-based material flow Production control (WIP) assembly processes Intra Logistic material flow between plants
Key ROI Elements Electronic Kanban Reduce levels of in-process inventory Maintain tight control of in-process inventory levels Implement Just-in-Time inventory flow with outside vendors
Kanban Systems Plant based material flow System to provide just-in-time (JIT) delivery Key points: Manage workflow & limit WIP
Electronic Kanban plant-based material flow Moving to ekanban to eliminate: manual entry lost cards Tracked by RFID and Barcode
Plant Functions requiring Traceability: Asset Tracking plant-based assets Electronic Kanban plant-based material flow Production control (WIP) assembly processes Intra Logistic material flow between plants
Production control (WIP) assembly processes Used to control automation processes and track work through entire process Key for flexible manufacturing
Build Data Key component in a Flexible Manufacturing Environment
Process Data Drives rework and Statistical Process Control (SPC) Rework Lane
Lineage Data Tracing all components to their source Critical for: Recall information Liability claims Regulatory compliance
Lineage Concept Data from multiple locations into one location
Tracking Options RFID Tag on Pallet Ideal for palletized assembly RFID Tag on Part Ideal when there is no pallet or part leaves the pallet
Plant Functions requiring Traceability: Asset Tracking plant-based assets Electronic Kanban plant-based material flow Production control (WIP) assembly processes Intra Logistic material flow between plants
Key ROI Elements Intra Logistics Maintain tight flow control with multiple sub suppliers Reduce time and potential errors when receiving components Maintain high level of visibility and traceability from sub suppliers to finished products Maintain regulatory compliance
Intra Logistic material flow between plants
Closed loop intra plant part flow Also called Product Logistics Tracking the flow between plants
Related Topics SE02 Balluff RFID SE03 Benefits of Image Based Barcode Reading SE08 Vision Solutions for the Food Ind. Solution Area 5 (Motion & Mechatronics)
SE09 Q&A