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LABELLING MACHINES IN THE PHARMACEUTICAL INDUSTRY PRESENTATION BY JOHN CLAYTON

LABELLING MACHINES IN THE PHARMACEUTICAL INDUSTRY PRESENTATION BY JOHN CLAYTON NEWMAN LABELLING SYSTEMS LTD. Regulation Security Features Applications Machinery In Action Tamper Evidence And Anti-counterfeiting Track & Trace; Current Status And Solutions Future Trends. Agenda.

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LABELLING MACHINES IN THE PHARMACEUTICAL INDUSTRY PRESENTATION BY JOHN CLAYTON

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  1. LABELLING MACHINES IN THE PHARMACEUTICAL INDUSTRY PRESENTATION BY JOHN CLAYTON NEWMAN LABELLING SYSTEMS LTD

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

  3. 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 Engineering Solutions

  4. Newman - committed to quality & Industry Compliance

  5. REGULATION

  6. FDA Top 10 reasons for Product 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.

  7. 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

  8. 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

  9. Validation PyramidCorrect Incorrect PQ PQ IQ OQ IQ OQ DQ DQ

  10. Compliance enhancement = Performance enhancement = Efficiency enhancement

  11. Validation to FDA & PICS (ISCP) Standards 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

  12. Validation to FDA & PICS (ISCP) Standards At Customer site:- • Installation Qualification (IQ) • Operation Qualification (OQ) • Process Qualification (PQ)

  13. SECURITY FEATURES

  14. Laser Coding

  15. THERMAL TRANSFER CODING

  16. OCR/OCV Visions Systems

  17. Dual Preprint & Overprint Inspection

  18. Dual OCV & Bar Code Inspection

  19. Pharmacode

  20. Colour Cap Detection/ Ring code reading

  21. Colour Coded Vial Tops

  22. Ring coded Ampoules

  23. APPLICATIONS

  24. CARTON LABELLING

  25. MACHINERY IN ACTION

  26. Vial and Bottle Labelling

  27. Maximum Versatility

  28. Ampoule labelling Vial, cartridge and Ampoule production

  29. Vial and ampoule labelling upto 250 cpm

  30. Syringe Labelling

  31. TAMPER EVIDENT LABELLING & ANTI-COUNTERFEITING

  32. Self adhesive T E Labels

  33. Hologram Labels

  34. Special Materials

  35. 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)

  36. TRACK & TRACE INITIATIVES • French CIP • ITS Turkey • EFPIA (Swedish Trial) • E-Pedigree (California USA) • China SFDA

  37. RFID TAG EMBEDDED INTO A LABEL

  38. “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.

  39. 2D Data Matrix ECC-200 Recommended by the EFPIA Data to include: Product code Randomised code Batch Number Expiry Date

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