Serialization for IBI

Serialization for IBI

Rockwell Automation/FMVision Integrated Architecture

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

2007

Founded in 1918 by

Prof. Giovanni Lorenzini continues to be a fully independent Company

on the international pharmaceutical scene.

plant

1975 1918

Production 4

Worldwilde

Export

Contract

Development

Manufaturing

service

Business lines

4

EUROPE

37

56

Retail Italy

Authorized to produce IMP GMP production of Rec-proteins (API) Registration services: IMP and MA cGMP production of sterile penicillins (API) Analytical validations, stability testing Experience and Expertise For all needs

CDMS for orals, topicals, injectables Pharmaceutical development GMP plant for nano and microparticles Batch release

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

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

Agenda

FM Vision – Serialization-ready Print&Check Module

Rockwell Automation – Turn-key Serialization Solution

Rockwell Automation

Project Team

Lead Engineer Valerio Frediani Project Engineers Massimo Lusa Eric Deschamps Mathieu Hiesse Tristan De Ines Rodriguez

Volker Lehmann

Project Management Office Account Manager

Mario 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 Lead Alessandro 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

Integrated Architecture – IT Model

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

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 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

2016

1997

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

FMVision

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FMVision

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FMVision

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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

Alessandro Zaffaroni

Operations Manager Southern Europe Life Sciences Solutions

Tel. +390233447250 Cell. +393476522024

RockwellAutomation

Via Gallarate, 215 – 20151 Milano – Italy

www.rockwellautomation.com

Ing. Augusto Falchetti Frescura Fondatore FM VISION Tel: +39 0742459082 Mobile: +39 3939621062 E-mail: [email protected] FMVision s.r.l. ... www.fmvision.it Luca Cesari

Software Development Manager Mob +39 335 7423168

Tel. +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