Embed Size (px)
Citation preview
Serialization for IBIRockwell Automation/FMVision Integrated Architecture
Castelraimondo (MC), Italy, 12th MAY 2016
Agenda
FM Vision – Serialization-ready Packaging Module
Rockwell Automation – Turn-key Serialization Solution
IBI – the Serialization Challenge
Agenda
FM Vision – Serialization-ready Packaging Module
Rockwell Automation – Turn-key Serialization Solution
IBI – the Serialization Challenge
2007
Founded in 1918 by
Prof. Giovanni Lorenzini continues
to be a fully independent Company
on the international pharmaceutical scene.
plant1975
1918
IBI plant produces according to cGMP standards and is certified by:
Production 4
WorldwildeExport
ContractDevelopmentManufaturingservice
Business lines4
EUROPE
37% 56%
Retail Italy
Authorizedto produce
IMP
GMP production
of Rec-proteins(API)
Registrationservices:
IMP and MA
cGMP production of
sterile penicillins (API)
Analyticalvalidations, stabilitytesting
Experience and
Expertise For all needs
CDMS for orals, topicals,
injectables
Pharmaceuticaldevelopment
GMP plant for nano and
microparticles
Batch release
One partner from product development to the market
Serialization: Regulation Requirement and scope
Serial numbers have to be aggregated to handle them along the supply chain
Single pack
Box
Serial number for every “unit of sale” (pack level)
Aggregation: Single packs to Box
Record of serial numbers of single packs that went in the Box
Record of serial numbers of Box that went on the pallet
Aggregation: Box to pallet
Pallet
Scan of pallet and connection to database provides all serial numbers of single items on the pallet
Serialization: Track & Trace System and Aggregation
Serialization: Track & Trace System and Aggregation
Why IBI selected FM Vision – Rockwell solution
• FM well- known supplier and appreciated for providing vials filled Visual Inspection Machines
• Rockwell world- leading brand
• Excellent skills and knowledge of the “field problems“
• Customer oriented solution ( not rigid in its design )
• Approach " Solution oriented " and " Production Oriented " in the proposed solutions
• Reliable connections with Trace Link
• Links for IBI to bring within the plant the Pharma Suite platform to implement the electronic BR (Great
Plus for the solution selected)
Project Timeline
• January – August 2015 Vendor screening
• September – October 2015 Vendor Selection
• November 2015 Order Issue
• December 2015 – February 2016 Documentation Finalization (URS, Quality Plan, Etc,…)
• June 2016 First serialization Machine installation
• August 2016 Second and Third Machine Installation
• September 2016 Last two machine Installation
• October 2016 – December 2016 System Validation and AIFA approval
• From January 2017 Customer PQ Finalization
Agenda
FM Vision – Serialization-ready Print&Check Module
Rockwell Automation – Turn-key Serialization Solution
IBI – the Serialization Challenge
Serialization for IBI – Rockwell Automation at a glance
Rockwell Automation – Global Solutions team
Rockwell Automation Project Team
Team LeaderAlessandro Zaffaroni
Project ManagerAldo Spanò
Quality ManagerFilippo Luzi
Quality Engineers (ad hoc)
Lead EngineerValerio Frediani
Project EngineersMassimo Lusa
Eric DeschampsMathieu Hiesse
Tristan De Ines RodriguezVolker Lehmann
Project Management Office
Account ManagerMario Meloni
Rockwell Automation proposes that the project team will consists of both Rockwell Automation’s and the customer’s personnel working closely together. This type of teaming has proven to be very successful on previous projects and has delivered solutions that not only meet the customer’s specification but also exceed their expectations.
Project Team
Customer’s Project Manager
Customer’s Project Team
Functional LeadAlessandro Stroscio
Rockwell Automation – Project Management
• Certified project managers
• Project Management Institute (PMI) knowledge base combined with our domain expertise.
• Project Methodology
• Comprehensive processes
• Project Management Methodology
• Delivery methodology
• Includes tools and standards
• Standard project templates
• Business systems
• Specific Project Management Functions
• Mitigate Risks
• On-Time and On-Budget
• Promotes consistency and Quality
Rockwell Automation – Project Delivery
Serialization Challenges
Rockwell Automation/FMVision Integrated Architecture
Rockwell Automation/FMVision Integrated Architecture
Rockwell Automation/FMVision Integrated Architecture
PharmaSuite – MES platform for Life Science
Serialization Operations – High Usability GUI
Integrated Architecture – IT Model
Line
Controller #3
Line
Controller #2
MMM
Line #1 Line #2 Line #3 Line #4
Line
Controller #4
M
Line
Controller #1
M M M
Database
PEC Server
Virtual Machine #1
Line#1 Interface Service
Virtual Machine #2
Line#2 Interface Service
Virtual Machine #3
Line#3 Interface Service
Virtual Machine #4
Line#4 Interface Service
Lince Controller Interface
PharmaSuite
Integration Gateway
Reprint/Rework Station
Production Management Client
Line #3 Client
Line #4 Client
Line #2 Client
Line #1 Client
Why Rockwell Automation and FMVision
• Complete Turn-Key Solution from Level 0/1 to Level 3 with inherent capabilities to
interface to external systems (MES, ERP, EPCIS Certified Repositories)
• Modular, flexible, scalable and configurable solution easily capable of meeting variable
international regulations
• Technology based on pre-validated “Commercial Off The Shelf” components, compliant
with GxP computerized systems (21 CFR Part 11) and using standard open communications
protocols
• Open platform capable of easily interfacing with existing packaging line equipment
• PharmaSuite platform ready for MES implementation
• World class Project Management
Agenda
FM Vision – Serialization-ready Print&Check Module
Rockwell Automation – Turn-key Serialization Solution
IBI – the Serialization Challenge
- La FM VISION SRL, nasce dalla trasformazione dela FM Engineering srl, società fondata nel1997 dall’Ing. Augusto Falchetti Frescura, con la Vision di diventare una importante referenzaper quanto riguarda l’ispezione automatica ON LINE con sistemi di visione artificiali negliimpianti FOOD, BEVERAGE e PHARMA.
- FM VISION progetta e costruisce Macchine per il trasporto, condizionamento ed ispezioneautomatica con relativa espulsione dei prodotti NON CONFORMI.
EASY TO USEHW e SW INDUSTRIALIFLESSIBILITA’PERSONALIZZAZIONIMODULARITA
20161997
INTRODUZIONE
FMVision
• .....
• .....
• .....
-Sistema di trasporto“4Way”-Velocità: 300 pz/min-Stampa in tutte le posizioni del contenitore-Verifica della stampa-Controllo contenuto etichetta-Controllo qualità etichetta-Cambio Formato completamente automatico e motorizzato-Unit Controller con Panello Operatore per la gestione della macchina
FM Vision Track&Trace-Serialization Machine
FMVision
• .....
• .....
• .....FM Vision Track&Trace-Serialization Machine
FMVision
• .....
• .....
• .....FM Vision Track&Trace-Serialization Machine
FMVision
• .....
• .....
• .....FM Vision Track&Trace-Serialization Machine
IBI Serialization Project Contact Persons
Luca PezzanoDirettore OperativoTel. +390692150526Cell. +393466524898
IBI - Istituto Biochimico Italiano Giovanni Lorenzini SpaVia Fossignano, 2 - 04011 Aprilia (LT)
Società controllata dalla Ibigen SrlRegistro Imprese Latina n. 01879840120
www.ibi-lorenzini.com
Alessandro ZaffaroniOperations Manager Southern Europe
Life Sciences SolutionsTel. +390233447250Cell. +393476522024
Rockwell Automation Via Gallarate, 215 – 20151 Milano – Italy
www.rockwellautomation.com
Ing. Augusto Falchetti FrescuraFondatore FM VISION Tel: +39 0742459082
Mobile: +39 3939621062E-mail: [email protected]
FMVision s.r.l.......................www.fmvision.it
Luca CesariSoftware Development Manager
Mob +39 335 7423168Tel. +39 0732 67.66.20
Email: [email protected]
ESISoftware s.r.l.Via Pian di Morro I, 1/A – 60043 Cerreto D’Esi (AN) - Italy
www.esisoftware.it
G.Lorenzini
