Serialization for IBI Rockwell Automation/FMVision Integrated Architecture Castelraimondo (MC), Italy, 12 th MAY 2016
Agenda IBI the Serialization Challenge Rockwell Automation Turn-key Serialization Solution FM Vision Serialization-ready Packaging Module
Agenda IBI the Serialization Challenge Rockwell Automation Turn-key Serialization Solution FM Vision Serialization-ready Packaging Module
1918 Founded in 1918 by Prof. Giovanni Lorenzini continues to be a fully independent Company on the international pharmaceutical scene. IBI plant produces according to cgmp standards and is certified by: 2007 plant 1975
4Business lines Contract Development Manufaturing service Retail Italy EUROPE 37% Production 4 56% Worldwilde Export
One partner from product development to the market GMP plant for nano and microparticles GMP production of Rec-proteins (API) Authorized to produce IMP Pharmaceutical development Analytical validations, stability testing CDMS for orals, topicals, injectables cgmp production of sterile penicillins (API) Experience and Expertise For all needs Batch release Registration services: IMP and MA
Serialization: Regulation Requirement and scope
Serialization: Track & Trace System and Aggregation Serial numbers have to be aggregated to handle them along the supply chain Single pack Serial number for every unit of sale (pack level) Aggregation: Single packs to Box Box Record of serial numbers of single packs that went in the Box Aggregation: Box to pallet Pallet Record of serial numbers of Box that went on the pallet Scan of pallet and connection to database provides all serial numbers of single items on the pallet
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 IBI the Serialization Challenge Rockwell Automation Turn-key Serialization Solution FM Vision Serialization-ready Print&Check Module
Serialization for IBI Rockwell Automation at a glance
Rockwell Automation Global Solutions team
Rockwell Automation Project Team Account Manager Mario Meloni Team Leader Alessandro Zaffaroni Project Management Office Quality Manager Filippo Luzi Project Manager Aldo Spanò Customer s Project Manager Lead Engineer Valerio Frediani Functional Lead Alessandro Stroscio Customer s Project Team Quality Engineers (ad hoc) Project Team Project Engineers Massimo Lusa Eric Deschamps Mathieu Hiesse Tristan De Ines Rodriguez Volker Lehmann 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.
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 Production Management Client Integration Gateway Line #1 Client Line #2 Client Line #3 Client Line #4 Client Reprint/Rework Station Virtual Machine #1 Line#1 Interface Service Virtual Machine #2 Line#2 Interface Service PEC Server Virtual Machine #3 Line#3 Interface Service Virtual Machine #4 Line#4 Interface Service Database PharmaSuite Lince Controller Interface M M M M M M M Line Controller #1 Line Controller #2 Line Controller #3 Line Controller #4 Line #1 Line #2 Line #3 Line #4
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 IBI the Serialization Challenge Rockwell Automation Turn-key Serialization Solution FM Vision Serialization-ready Print&Check Module
INTRODUZIONE - La FM VISION SRL, nasce dalla trasformazione dela FM Engineering srl, società fondata nel 1997 dall Ing. Augusto Falchetti Frescura, con la Vision di diventare una importante referenza per quanto riguarda l ispezione automatica ON LINE con sistemi di visione artificiali negli impianti FOOD, BEVERAGE e PHARMA. - FM VISION progetta e costruisce Macchine per il trasporto, condizionamento ed ispezione automatica con relativa espulsione dei prodotti NON CONFORMI. EASY TO USE HW e SW INDUSTRIALI FLESSIBILITA PERSONALIZZAZIONI MODULARITA 1997 2016
FMVision......... FM Vision Track&Trace-Serialization Machine -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
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 Pezzano Direttore Operativo Tel. +390692150526 Cell. +393466524898 IBI - Istituto Biochimico Italiano Giovanni Lorenzini Spa Via Fossignano, 2-04011 Aprilia (LT) Società controllata dalla Ibigen Srl Registro Imprese Latina n. 01879840120 www.ibi-lorenzini.com Ing. Augusto Falchetti Frescura Fondatore FM VISION Tel: +39 0742459082 Mobile: +39 3939621062 E-mail: a.falchettifrescura@fmvision.it FMVision s.r.l.... www.fmvision.it Alessandro Zaffaroni Operations Manager Southern Europe Life Sciences Solutions Tel. +390233447250 Cell. +393476522024 Rockwell Automation Via Gallarate, 215 20151 Milano Italy www.rockwellautomation.com Luca Cesari Software Development Manager Mob +39 335 7423168 Tel. +39 0732 67.66.20 Email: luca.cesari@esisoftware.it ESISoftware s.r.l. Via Pian di Morro I, 1/A 60043 Cerreto D Esi (AN) - Italy www.esisoftware.it
G.Lorenzini