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 Patient Safety

COMPLYING With Regulations

PROTECTING Brand Reputation

TRACING Through Supply Chain

 Regulations

Pharmaceutical & Medical Device

21 CFR Part 801 (1990)
21 CFR Part 11 (1997)
GAMP V (2008)
FDA Public Law 113-54 Initiatives
DQSA/DSCSA (2013) *Drug Quality & Security Act DQSA
Drug Supply Chain Security Act DSCSA
UDI (2014)
FDA Public Law 110-85 Sec 226
ePedigree (2015) Unique Device Identification - UDI
 Track & Trace, ePedigree, Serialization
Diagnostics
Product/Batch ID & Test Kits

Pharm - per product

Medical - product Medical Delivery
Instruments Devices
and batch code Pharmaceuticals
Rx Drugs
and OTC Medicines

Patient Safety #1
Anti-Counterfeiting
Vitamins & Cosmetics
Recall Effectiveness Supplements

Product Diversion
 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 Packaging Plants

5700 lines
North
Japan, 513 America,
2733 Retrofit New Lines
(70%) (30%)
Europe,
1485

* 2011 Cognex Market Survey

 Interesting Data

Source: 2014 Stericycle ExpertSOLUTIONSTM, www.stericycleexpertsolutions.com

 Interesting Data

Source: 2014 Stericycle ExpertSOLUTIONSTM, www.stericycleexpertsolutions.com

 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 its 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

FDA publishes additional guidance and requirements

2014

Manufacturers affix serialized information on unit level packaging and homogenous cases
Nov. 2017 Implement verification system

Repackagers affix serialized information to packages and cases

Nov. 2018 Implement verification system

Distributors must verify all suspect product using serialized information

Nov. 2019

Dispensers must verify 10% of suspect product at lot level

Nov. 2020

All segments must use serial numbers and transfer data in secure manner
Nov. 2023

Most Pharma companies will pilot fully functioning lines

two years before mandate (i.e. 2015)
 UDI Implementation Timeline

Class III devices must carry UDI Label on labels and packaging
Sept. 2014

Implantable, life-saving, and life-sustaining Class I & II devices must carry UDI
Sept 2015 on labels and packaging

Class II device must carry a UDI on labels and packaging

Sept 2016 Class III devices that require DPM must carry permanent UDI on device

Class I devices must carry UDI on labels / packaging

Sept 2018 Class II devices that require DPM must carry UDI on device

Class I devices that require DPM must carry permanent UDI on device
Sept 2020

The time to implement in now!

 Whats Your Game Plan?

Wait and See Act Now

Analysis paralysis? Interview/select vendors!
Develop IT plan!
Budget for next year?
Build Pilot Line!
Hope for the best?
 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
Read Pallet Code
Off-Line Data Matrix Quality Verification

Read Carton Code

Grade Code Read Read Read
Verify Printed Text Codes in Bundle Bundle Code Case Code

Print Carton Code Print Bundle Code Print Case Code Print Pallet Code
And Human Readable Data
 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 User Requirement

Specification
Performance
Qualification
Verification

2 Firmware Functional
Specification
Operational
Qualification

3 Non-Configured Systems Design

Specification
Installation
Qualification

4 Configured Systems System

Development

5 Custom Applications
 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

ERP System Out to Logistics /

Enterprise-level (SAP, Oracle) Supply Chain

User Manufacturing Part 11

Serialization
Partners Plant-level Authentication
Execution
System System
Compliance
Database

Line Management Cognex Audit Message

Line-level Software HMI Display 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 Reduce asset losses

Ensure correct asset is used Reduce asset's non-
Increase overall asset productivity productive 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 RFID Tag on Part

Ideal for palletized assembly 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