SOLUTION FOR PHARMA & MEDICAL DEVICES MARKET€¦ · · 2017-05-06SOLUTION FOR PHARMA & MEDICAL...

15/6/2017Videojet Pharma Line Introduction

SOLUTION FOR PHARMA & MEDICAL DEVICES MARKET


Danaher and Videojet overview

VideojetLife

SciencesDiagnostics Dental

Environmental

& Applied Sol.

Top NYSE conglomerate

~ 59.000 employees worldwide in 130 different countries

~ USD 16.6 billion in sales (2015)

NSYE stock valued at USD 81.39 (15 Aug. 2016)

World leader in coding

> 4.000 employees worldwide in 30 different countries

Represented in 135 countries

> USD 1 billion in sales

Technology Portfolio

Continuous

Inkjet

Thermal

Inkjet

Laser

Marking

Thermal

Transfer

Overprinting

Case

Coding

Label Print

& Apply

Key Markets

Pharma

Food

Beverage

CPG

Water Quality

Product ID

~USD 5.0B

revenue*

~USD 5.0B

revenue

~USD 2.8B

revenue

~USD 3.8B

revenue

5/6/2017 3

201520122011200920082007200620042003

Videojet

(May 02)

Danaher

entry into

Product

ID market

Willett

(Jan 03)

Channel/

Geographic

Expansion

Alltec

(May 04)

Technology

Bolt-On

(Laser)

Zipher

(Jun 04)

Tech. Bolt-On

(Thermal

Transfer

Overprinting)

Lite Laser

(Nov 06)

Technology

Bolt-On

(Laser)

Claricom

(Mar 08)

Connectivity

2002

Prism

(Aug 07)

Brand

Protection

and

Serialization

Foba

(Sept 09)

Application

Expansion

(Parts

Marking)

Wolke

(Oct 09)

Product/

Channel (TIJ

+ Pharma)

EskoArtwork

(Market

expansion –

digital

packaging)

HISTORY

1960

Videojet

(Start)

X-rite

(Dec 12)

Color

science

and

technology

Laetus

(Dec 15)

Track and

Trace

manufacture

http://www.esko.com/web/site.aspx?p=23

http://www.esko.com/web/site.aspx?p=23


xxxVideojet Technologies is a world leader in industrial coding and marking solutions with a dedicated

global pharmaceutical team supporting organizations and supply chain partners with solutions,

certifications and fast, reliable service. A product portfolio including thermal inkjet, laser marking,

continuous inkjet and labeling provides consistent, high-quality serialization and traceability codes,

helping the pharmaceutical and medical device industries safeguard their products against

counterfeiting and protect consumer safety. With a wide range of technologies addressing virtually any

application, Videojet is the expert in realizing the specific requirements of a wide range of healthcare

applications.

With decades of knowledge, Videojet Technologies’ expertise in industry standards and global regulations makes them the right partner

for understanding complex coding needs. Videojet solutions code 10 billion products a day worldwide, playing a vital and responsible role

in the world. With over 4,000 associates serving 135 countries, Videojet has the capability to provide local service through global

resources.


Drugs counterfeiting:a worldwide and growing public health issue

% of Counterfeit Drugs on Sale

Between 20% and 30%

Between 10% and 20%

Between 1% and 10%

Less than 1%

Source: 2008, Sanofi Aventis - http://ec.europa.eu/internal_market/indprop/docs/conf2008/wilfried_roge_en.pdf

http://ec.europa.eu/internal_market/indprop/docs/conf2008/wilfried_roge_en.pdf


The solution = legislation

DSCSADrug Supply Chain

Security Act

(part of the Drug Quality

Security Act, or “DQSA“)

FMDFalsified

Medicines

Directive

Pre

scriptio

n D

rug

sM

edic

al D

evic

es

Rest of WorldUnited StatesEurope

UDIUnique

Device

Identification(still to be published)

UDIUnique

Device

Identification

Different

legislations for

different

countries

…


Timeline: prescription drugs worldwide


Timeline: medical devices

USA - UDI

Sep 2018 Class I

Sep 2016 Class II

Sep 2014 Class III

Medical Devices Classes

Class I (low risk)

Class II

Class III (high risk)


Timeline USA + EU focus: table format DSCSA + UDI + FMD

United StatesEnactement Compliance

Manufacturers Repackagers Wholesalers Dispensers

DSCSA Dates (PRESCRIPTION DRUGS) 27 Nov 2015

Lot Level Traceability 01 Jan 2015 01 Jan 2015 01 Jan 2015 01 Jul 2015

Pack Level Traceability à "Serialization" 27 Nov 2017 27 Nov 2018 27 Nov 2019 27 Nov 2020

Aggregation Traceability 27 Nov 2023 27 Nov 2023 27 Nov 2023 27 Nov 2023

DSCSA Key Requirements Prescription Drugs

Datamatrix ECC 200 Code (No need for Tamper Evidence)

UDI (MEDICAL DEVICES - items manufacture date) 24 Sept 2014

Class I (low risk) 24 Sept 2018

Class II 24 Sept 2016

Class II/I: implants & life supporting 24 Sept 2015

Class III (high risk) 24 Sept 2014

EuropeEnactement Compliance

Manufacturers Repackagers Wholesalers Dispensers

FMD Dates (PRESCRIPTION DRUGS) 2 Jan 2013

Lot Level Traceability

Pack Level Traceability à "Serialization" 9 Feb 2019 9 Feb 2019 9 Feb 2019 9 Feb 2019

Aggregation Traceability

FMD Key Requirements Prescription Drugs

Datamatrix ECC 200 Code + Tamper Evidence

UDI (MEDICAL DEVICES) TBD ~Sept 2016

Class I (low risk) TBD

Class II TBD

Class III (high risk) TBD

(excludes Italy, Belgium, Greece: all have own country solution and will be given longer time by EU to comply with new regulation)


Legislation demands a serialized code

The serialized

information must be

made available in

databanks for a

period of time

For a pharma company all this

boils down to a code on the

pack – either a linear (1D) or

DataMatrix (2D) code,

depending on the jurisdiction –

which should be saved in a

databank and made available

for traceability purposes

Step #1: Code Application

Prescription drugs must be serialized i.e. each gets a unique serial

number in order to provide traceability throughout the supply chain

The code can be applied onto primary packaging (e.g. blister), secondary

packaging (e.g. folding box) or onto tertiary packaging (e.g. palette) – in

Europe only requirement for pack-level serialization until now; in USA

aggregation (e.g. palette) until 2023

Lin

ear

2D

1

2

3

4 An internationally accepted serialization scheme is provided by

organization GS1 through the scheme GS1 SGTIN (01+02). It defines for

serialization:

• The “type of code” (i.e. “the graph”) to be DataMatrix ECC 200

• The “content of the code” (i.e. “the text”) to be (01) Product Code

“GTIN”; (10) Lot Number; (17) Expiration date; (21) Serial Number

Step #2: Data Storage


Why Videojet

Highly experienced in

pharma coding and

marking

Well-versed in industry

standards and global

regulations

Global coverage

Broad range of coding

Technologies

Process validation in

accordance to GAMP 5

Test service for codes on

pharmaceutical cartons

Pharma Hub:

videojet.com/pharma

White Papers

Application Notes

Track & Trace Guidelines

Instructive animations

& videos

Dedicated team of

international pharma

experts

Industry-specific

solutions

and services

Up-to-date

information

5/6/2017 12

Dedicated team of international pharma experts

• Pharma business unit is a specialized engineering partner

for our customers.

• We know the special requirements of mechanical

engineering and can support you at each stage.

• The design, validation, installation and sustainable on-site

supervision of our customer are cornerstones of these

processes.

• A qualified customer service team and technical

supporters care about the realization of projects in the

global network of Videojet.

• The Pharma supporters coordinate over 1500 service

technicians on all continents

• Local support of your customer:

• Instruction and training in local language

• Rapid supply of equipment and spare parts

• On site warranty – where ever your plants may be

installed

• Maintenance and repair according to

manufacturer's quality standards

• Globale Videojet Cross Border Policy


Thermal Inkjet Continuous Inkjet Laser

Thermal Transfer Large Character Marking Label Printer Applicator

Industry-specific solutions and services

UV

CO2

Fiber

Specifically engineered for pharmaceutical applications


Laser Continuous Inkjet (CIJ)Thermal Inkjet (TIJ) Thermal Transfer Overprinter (TTO)Large Character Marking &

Label Printer Applicator

Industry-specific solutions

and servicesIndustry-specific solutions and services




Code2Carton Videojet Sample Lab

Sample Lab Locations

Trust Videojet to match the optimal solution to your substrate – ensuring

repeatable, machine readable codes

When it comes to traceability, it is crucial that the codes on

pharmaceutical products remain readable over the long term.

Yet influences along the supply chain such as condensation or

UV radiation may blur or fade the code.

In order to help ensure optimum marking quality on your

packaging, Videojet has worked together with the Paper

Technology Foundation (PTS) to offer a test for Videojet codes

on the folding cartons that you use.

Different technologies can be tested and different tests can be

performed, among them is CO2 Laser. Following tests can be

performed:

Light fastness (resistance of colors under light)

Optimum marking thickness

Videojet has strategically located sample labs to service

Americas, EMEA and Asia.

The sample labs allow customers to have different substrates

tested for different wavelengths, thus ensuring optimal marking.



and servicesUp-to-date information


LASER

Videojet Proprietary and Confidential

Technology Product Code sample Benefits

Laser• No supplies needed

• High print quality mark &

permanent


TIJ: Thermal Ink Jet



Thermal ink jet• Clean & ultra low maintenance

• High quality 2D bar codes


LPA: Label Print Applicator


Label Print Apply

• Automated label print & apply onto boxes

and shrink wrap

• Direct Print & Apply



Continuous

ink jet

• High speeds, high throw distance

• Adhesion on virtually all substrates

with fast drying inks

CIJ: Continuous Ink Jet



Thermal

transfer

• High quality codes on flexible

packaging and labels

• Can print on high gloss stock

TTO: Thermal Transfer Overprinting




Drop on

Demand

• Variable data, barcodes and graphics

on boxes and shrink wrap

LCM: Large Character Marking


Thank you!

Aldo JonaSales Key Account Pharma - Italia

Via XXV Aprile, 66/C

20068 – Peschiera Borromeo (MI)

Italia

Email: [email protected]

Tel: +39 02 55 37 6811

Mob: +39 346 806 1700

mailto:[email protected]

SOLUTION FOR PHARMA & MEDICAL DEVICES MARKET€¦ · · 2017-05-06SOLUTION FOR PHARMA & MEDICAL...

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