LABELLING MACHINES IN THE LABELLING MACHINES IN THE PHARMACEUTICAL INDUSTRYPHARMACEUTICAL INDUSTRY

PRESENTATION PRESENTATION BY JOHN CLAYTONBY JOHN CLAYTON

NEWMAN LABELLING NEWMAN LABELLING SYSTEMS LTDSYSTEMS LTD

Agenda• Regulation• Security Features• Applications• Machinery In Action• Tamper Evidence And Anti-counterfeiting• Track & Trace; Current Status And Solutions• Future Trends

Engineering Solutions

We have a thorough understanding of the engineering solutions necessary to label ampoules, vials, cartridges, syringes and cartons at speeds of up to 600 containers per minute

Newman - committed to quality & Industry ComplianceNewman - committed to quality & Industry Compliance

REGULATION

FDA Top 10 reasons for FDA Top 10 reasons for Product Recalls 1995Product Recalls 1995

FDA Reasons for Product recall

1 Failed USP dissolution testing.

2 LABEL MIX UP.

3 cGMP DEVIATIONS.

4 Sub potent drug.

5 Stability Data Incorrect.

Two newborn babies died at the University Hospital in Leuven Belgium

following the administration of “Glucose 5%” filled from 10ml

Ampoules. Unfortunately analysis from the Belgium authorities showed that the ampoules had been mislabelled - they contained potassium chloride

Relevant cGMP Guidelines:• Easy Line Clearance• In Process Control• Batch Packaging Records• Critical Device Checks• Batch & Exp print resilient to fading or erasing• Roll fed labels preferred• Full label reconciliation• CFR 21 Part II

Validation PyramidValidation Pyramid

Correct IncorrectCorrect Incorrect

Compliance Compliance enhancementenhancement

==Performance Performance enhancementenhancement

==

Efficiency Efficiency enhancementenhancement

Validation to Validation to FDA & PICS FDA & PICS

(ISCP)(ISCP) StandardsStandards

Protocols:-Pre-Delivery• Functional Design

Specification (FDS)• Design Qualification (DQ)• Traceability Matrix (TM)• Risk analysis (RA)• Master Plan• Document approvals• Machine system test Protocol• Pre-Delivery Machine Test

Protocol

Validation to Validation to FDA & PICS FDA & PICS

(ISCP)(ISCP) StandardsStandards

At Customer site:-

• Installation Qualification (IQ)• Operation Qualification (OQ)• Process Qualification (PQ)

SECURITY FEATURES

Laser Coding

THERMAL TRANSFER CODING

OCR/OCV Visions Systems

Dual Preprint & Overprint Dual Preprint & Overprint InspectionInspection

Dual OCV & Bar Code Dual OCV & Bar Code InspectionInspection

Pharmacode

Colour Cap Detection/ Ring code reading

Colour Coded Vial TopsColour Coded Vial Tops

Ring coded Ring coded AmpoulesAmpoules

APPLICATIONS

CARTON LABELLING

MACHINERY IN ACTION

Vial and Bottle Labelling

Maximum Maximum VersatilityVersatility

Ampoule labelling

Vial, cartridge and Ampoule production

Vial and ampoule labelling upto 250 cpm

Syringe Labelling

TAMPER EVIDENT LABELLING & ANTI-COUNTERFEITING

Self adhesive T E Labels

Hologram Labels

Special Materials

TRACK AND TRACE

The World Health Organisation estimates that between 5% to 8% of the

worldwide trade in pharmaceutical is counterfeit.

In two months 34m counterfeit tablets were seized in the European Union (EU).

European Federation of Pharmaceutical and Industries Association (EFPIA)

TRACK & TRACE INITIATIVESTRACK & TRACE INITIATIVES

• French CIP

• ITS Turkey

• EFPIA (Swedish Trial)

• E-Pedigree (California USA)

• China SFDA

RFID TAG EMBEDDED INTO A LABEL

“The principle is that every pack’s unique serial number is fed into a database and removed when the product issued by the pharmacy, meaning that each code can only be used once.

2D Data Matrix ECC-200 Recommended by the EFPIA

Data to include:• Product code• Randomised code• Batch Number• Expiry Date

2D Matrix Code

Faulty Label Removal - FLR

Faulty Label Removal

FUTURE TRENDS

IN PHARMACEUTICAL LABELLING

PRE-FILLED SYRINGE PRODUCTION

US market has been growing at a rate of 20% per year for at least five years.

Plastic Pre-filled syringesPlastic Pre-filled syringes

Extended label applicationExtended label application

Double layer Double layer labellabel

Multiple detachable portionsMultiple detachable portions

Leaflet LabelsLeaflet Labels

Multi-wrap labelsMulti-wrap labels

Needle Protect

Label

THANK YOU FOR YOUR THANK YOU FOR YOUR TIMETIME

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