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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
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Agenda• Regulation• Security Features• Applications• Machinery In Action• Tamper Evidence And Anti-counterfeiting• Track & Trace; Current Status And Solutions• Future Trends
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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
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Newman - committed to quality & Industry ComplianceNewman - committed to quality & Industry Compliance
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REGULATION
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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.
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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
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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
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Validation PyramidValidation Pyramid
Correct IncorrectCorrect Incorrect
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Compliance Compliance enhancementenhancement
==Performance Performance enhancementenhancement
==
Efficiency Efficiency enhancementenhancement
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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
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Validation to Validation to FDA & PICS FDA & PICS
(ISCP)(ISCP) StandardsStandards
At Customer site:-
• Installation Qualification (IQ)• Operation Qualification (OQ)• Process Qualification (PQ)
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SECURITY FEATURES
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Laser Coding
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THERMAL TRANSFER CODING
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OCR/OCV Visions Systems
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Dual Preprint & Overprint Dual Preprint & Overprint InspectionInspection
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Dual OCV & Bar Code Dual OCV & Bar Code InspectionInspection
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Pharmacode
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Colour Cap Detection/ Ring code reading
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Colour Coded Vial TopsColour Coded Vial Tops
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Ring coded Ring coded AmpoulesAmpoules
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APPLICATIONS
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CARTON LABELLING
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MACHINERY IN ACTION
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Vial and Bottle Labelling
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Maximum Maximum VersatilityVersatility
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Ampoule labelling
Vial, cartridge and Ampoule production
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Vial and ampoule labelling upto 250 cpm
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Syringe Labelling
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TAMPER EVIDENT LABELLING & ANTI-COUNTERFEITING
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Self adhesive T E Labels
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Hologram Labels
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Special Materials
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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)
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TRACK & TRACE INITIATIVESTRACK & TRACE INITIATIVES
• French CIP
• ITS Turkey
• EFPIA (Swedish Trial)
• E-Pedigree (California USA)
• China SFDA
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RFID TAG EMBEDDED INTO A LABEL
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“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.
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2D Data Matrix ECC-200 Recommended by the EFPIA
Data to include:• Product code• Randomised code• Batch Number• Expiry Date
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2D Matrix Code
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Faulty Label Removal - FLR
Faulty Label Removal
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FUTURE TRENDS
IN PHARMACEUTICAL LABELLING
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PRE-FILLED SYRINGE PRODUCTION
US market has been growing at a rate of 20% per year for at least five years.
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Plastic Pre-filled syringesPlastic Pre-filled syringes
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Extended label applicationExtended label application
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Double layer Double layer labellabel
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Multiple detachable portionsMultiple detachable portions
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Leaflet LabelsLeaflet Labels
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Multi-wrap labelsMulti-wrap labels
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Needle Protect
Label
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