Serialization for IBI

Transcription

1 Serialization for IBI Rockwell Automation/FMVision Integrated Architecture Castelraimondo (MC), Italy, 12 th MAY 2016

2 Agenda IBI the Serialization Challenge Rockwell Automation Turn-key Serialization Solution FM Vision Serialization-ready Packaging Module

3 Agenda IBI the Serialization Challenge Rockwell Automation Turn-key Serialization Solution FM Vision Serialization-ready Packaging Module

4

5 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

6 4Business lines Contract Development Manufaturing service Retail Italy EUROPE 37% Production 4 56% Worldwilde Export

7 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

8 Serialization: Regulation Requirement and scope

9 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

10 Serialization: Track & Trace System and Aggregation

11 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)

12 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

13 Agenda IBI the Serialization Challenge Rockwell Automation Turn-key Serialization Solution FM Vision Serialization-ready Print&Check Module

14 Serialization for IBI Rockwell Automation at a glance

15 Rockwell Automation Global Solutions team

16 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.

17 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

18 Rockwell Automation Project Delivery

19 Serialization Challenges

20 Rockwell Automation/FMVision Integrated Architecture

21 Rockwell Automation/FMVision Integrated Architecture

22 Rockwell Automation/FMVision Integrated Architecture

23 PharmaSuite MES platform for Life Science

24 Serialization Operations High Usability GUI

25 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

26 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

27 Agenda IBI the Serialization Challenge Rockwell Automation Turn-key Serialization Solution FM Vision Serialization-ready Print&Check Module

28 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

29 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

30 FMVision FM Vision Track&Trace-Serialization Machine

31 FMVision FM Vision Track&Trace-Serialization Machine

32 FMVision FM Vision Track&Trace-Serialization Machine

33 IBI Serialization Project Contact Persons Luca Pezzano Direttore Operativo Tel Cell IBI - Istituto Biochimico Italiano Giovanni Lorenzini Spa Via Fossignano, Aprilia (LT) Società controllata dalla Ibigen Srl Registro Imprese Latina n Ing. Augusto Falchetti Frescura Fondatore FM VISION Tel: Mobile: a.falchettifrescura@fmvision.it FMVision s.r.l Alessandro Zaffaroni Operations Manager Southern Europe Life Sciences Solutions Tel Cell Rockwell Automation Via Gallarate, Milano Italy Luca Cesari Software Development Manager Mob Tel luca.cesari@esisoftware.it ESISoftware s.r.l. Via Pian di Morro I, 1/A Cerreto D Esi (AN) - Italy

34 G.Lorenzini