TTM100 00 Manufacturing Line Serial Number Management System as - - PowerPoint PPT Presentation

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TTM100 00 Manufacturing Line Serial Number Management System as - - PowerPoint PPT Presentation

TTM100 00 Manufacturing Line Serial Number Management System as used in EU BRIDGE WP6 Pilot Project and Irish Blood Derivative Trials m e n t o r p h a r m a c e u t i c a l c o n s u l t a n t s e x p e r t a d v i c e i n t r a c k


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m e n t o r p h a r m a c e u t i c a l c o n s u l t a n t s

e x p e r t a d v i c e i n t r a c k & t r a c e , a u t h e n t i c a t i o n , r e g u l a t i o n , c o m p l i a n c e

TTM100 00

Manufacturing Line Serial Number Management System as used in EU BRIDGE WP6 Pilot Project and Irish Blood Derivative Trials

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m e n t o r p h a r m a c e u t i c a l c o n s u l t a n t s

e x p e r t a d v i c e i n t r a c k & t r a c e , a u t h e n t i c a t i o n , r e g u l a t i o n , c o m p l i a n c e

Introdu

  • duction

ction

  • TTM100 is:

– A simple to use serial number management system for production/manufacturing line use. – Interfaces with a variety of coding devices (which can be readily expanded) – Able to work with numerous vision systems and code readers (Cognex and Pepperl Fuchs used during BRIDGE) – Able to communicate, in two directions, with higher level hosts (such as Navision, SAP, Oracle Enterprise etc)

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m e n t o r p h a r m a c e u t i c a l c o n s u l t a n t s

e x p e r t a d v i c e i n t r a c k & t r a c e , a u t h e n t i c a t i o n , r e g u l a t i o n , c o m p l i a n c e

Descr crip iptio ion

  • TTM100:

– Has web-based user interface or it... – Has a ‘forms’ based user interface.

  • Is readily adapted to work with touch screen industrial PC equipment.
  • Uses components that have already been used in live manufacturing situations

(and continues to be today)

  • Uses easily adopted and adapted

XML interfaces for inter-system integration.

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m e n t o r p h a r m a c e u t i c a l c o n s u l t a n t s

e x p e r t a d v i c e i n t r a c k & t r a c e , a u t h e n t i c a t i o n , r e g u l a t i o n , c o m p l i a n c e

Technolo nology gy

  • TTM 100:
  • Uses Microsoft Windows TM Technologies
  • Is designed and built by a Microsoft Certified Partner organisation.
  • Uses .Net and makes extensive use of XML to ease interoperability
  • Is highly modular and easily adapted to specific requirements
  • Makes extensive use of proven code modules for reliability
  • Works with many existing customer owned systems
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m e n t o r p h a r m a c e u t i c a l c o n s u l t a n t s

e x p e r t a d v i c e i n t r a c k & t r a c e , a u t h e n t i c a t i o n , r e g u l a t i o n , c o m p l i a n c e

Why TTM100 0 ?

  • Used successfully during the BRIDGE pilot
  • Capable of flexible adaptation for

specific customer requirements

  • Uses a simple modular design to ease

testing and validation

  • Able to work with numerous

Database standards (e.g. MS SQL Server, Oracle etc)

  • TTM100 is able to apply serialised codes
  • nly or, as was undertaken during BRIDGE,

aggregation to over ten levels

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m e n t o r p h a r m a c e u t i c a l c o n s u l t a n t s

e x p e r t a d v i c e i n t r a c k & t r a c e , a u t h e n t i c a t i o n , r e g u l a t i o n , c o m p l i a n c e

Archit itec ectu ture re

  • TTM100 assumes that Enterprise level control will be assumed

by an existing enterprise suite (e.g. SAP, Oracle etc)

  • TTM100 is a client server architecture designed

for production facility integration.

  • TTM100 is architected to ensure that each

production line is autonomous and thus any individual system failure will remain isolated to a single failure instance (i.e. Not take down the entire manufacturing operation)

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SLIDE 7

m e n t o r p h a r m a c e u t i c a l c o n s u l t a n t s

e x p e r t a d v i c e i n t r a c k & t r a c e , a u t h e n t i c a t i o n , r e g u l a t i o n , c o m p l i a n c e

Coding ng Technology

  • logy
  • TTM100 is able to work with both:
  • Printed code data carriers such as DataMatrix,

Linear, PDF417 etc … and

  • RFID either GEN2 or HF.
  • TTM100 was designed to be data carrier agnostic

– the only limitations placed on the system will be the capability of the carrier.

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m e n t o r p h a r m a c e u t i c a l c o n s u l t a n t s

e x p e r t a d v i c e i n t r a c k & t r a c e , a u t h e n t i c a t i o n , r e g u l a t i o n , c o m p l i a n c e

Data Managem emen ent

  • Able to combine the elements of:

– GTIN/Product Code (NDC etc) – Serial Number – Expiry Date – Batch Code – In a user define construct to suit the coding application being undertaken e.g. BRIDGE, EFPIA etc

  • Retains all data constructed and

used to allow easy reconciliation.

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SLIDE 9

m e n t o r p h a r m a c e u t i c a l c o n s u l t a n t s

e x p e r t a d v i c e i n t r a c k & t r a c e , a u t h e n t i c a t i o n , r e g u l a t i o n , c o m p l i a n c e

Data Managem emen ent

  • TTM100 is able to produce reports for:

– Individual items – Container items (e.g. cases, pallets etc) and contents – System users – auditing actions

  • TTM100 can serialise using sequential numbers or random numbers.
  • TTM100 is able to adopt customer own randomisation algorithms either

directly within the system or via compatible dll (dynamic link library)

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m e n t o r p h a r m a c e u t i c a l c o n s u l t a n t s

e x p e r t a d v i c e i n t r a c k & t r a c e , a u t h e n t i c a t i o n , r e g u l a t i o n , c o m p l i a n c e

TTM205 05

  • Mobile Phone based

code scanning

10

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m e n t o r p h a r m a c e u t i c a l c o n s u l t a n t s

e x p e r t a d v i c e i n t r a c k & t r a c e , a u t h e n t i c a t i o n , r e g u l a t i o n , c o m p l i a n c e

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Contact Details: Tony Walsh, Mentor Pharmaceutical Consulting, 53 Welland Place, Ely, Cambridgeshire CB6 2XA UK Tel: +44(0) 1353 669218 Mobile: +44 (0) 7717156683 e-mail: info@mentorconsulting.eu Web site: www.mentorconsulting.eu

Some of the material shown herewith was created while working for: Domino Printing Sciences, Control Pharma or on behalf of Markem, EU Bridge and other organisations. Reference to Mentor Pharmaceutical Consulting in no way infers or implies that this presentations was given on behalf of Mentor or that any of the organisations shown are customers of Mentor at this point. These are organisations that members of Mentor have worked with and for over recent years.