2

Stevanato Group Brand Structure

PHARMACEUTICAL

SYSTEMS

ENGINEERING

SYSTEMS

CONVERTING

SYSTEMS

PHARMA

INSPECTION

SYSTEMS

PACKAGING,

ASSEMBLING &

SERIALIZATION

3

Stevanato Group Today

Brabrand

Monterrey

Bratislava

Zhangjiagang

Piombino Dese

Latina

Piombino Dese

Piombino Dese

Newtown, PA | Sales Office

Piombino Dese | Headquarters

Zhangjiagang | Sales Office

Sete Lagoas | Sales Office(plant under construction)

Silkeborg

Bad Oeynhausen

OceansideOntarioAnaheim

Timisoara

4

Structured Flexibility

5

From glasscomponent supplier

Reference Standard as a System Partner in parenteral devices,including Patients and healthcare providers

to

Focus on Patient and Customer

6

Each SG entity fits this approach

yesterday today and tomorrow

Engineering Division

8

Glass Process:

Converting

Technology

Assembling and

Serialization

PharmaInspection

Systems

9

Engineering Division | Competences

Sterile packaging• Handling of Sterile

Packaging RTU

containers

Pharma Inspection

Systems• Full range of Automatic

and semi – automatic

Inspection Machines

Glass Process:

Converting Technology• Glass converting

• glass treatment process

• 100% dimensional and cosmetic

in-line controls by camera

Packaging

Assembing and

Serialization• Pharma packaging

• Components assembling

• Track & Trace

10

Engineering Division | Solution Providers

SPACECompact Flexible solutions

FLEXIBILITYResponding to Smaller

batch sizes, enhancing

Return and Justification

CUSTOMIZATIONStandard Proven

Applications delivering

Customized Solutions

TECHNOLOGYState of art Reliable and

high performance Vision

and Robotics

TIME

Rapid change-over

Higher OEE

COMPLIANCEResponding to the latest

regulatory requirment

12

SVM Engineering

Martin Minet Nielsen

• Chief designer – Automation at SVM

• Electrical Engineering

• Graduated in 2011

• ~ 5 years as Automation Engineer

• ~ 15 years within automation and software

Leo Handberg

• Chief designer – Mechanics at SVM

• Mechanical Engineering

• Graduated in 1984

• ~ 30 years as Mechanical Engineer

• ~ 30 years within mechanical Design

13

Customized machine platforms

SerializationAssemblingPackaging

14

Serialization & Aggregation

GTIN

Serialization

Aggregation

Track & Trace

15

The process is our product

We have developed a strong process that we use for all projects. The process model

corresponds to the demanding requirements of the pharmaceutical industry.

We follow very structured processes in all aspects of our business from the initial

customer or lead contact to the servicing of the installed equipment.

We only focus on the pharmaceutical industry

16

Basic Design

Specification

Design

Specification

Design

Qualification

Report

Systematic description of how

the task will be solved

The description is made so that

project risks are evaluated,

necessary pre-investigations has

been carried out and sub

supplier quotation has been

collected

The description is accompanied

by drafts, pictures and 3D

modules that can illustrate the

concepts

The client can see what will be

purchased

The machine is split into Units (UM)

and Equipment Modules (EM)

according to the OMAC model

The Design Specification (DS)

contains all issues to Functional

Design Specification (FDS),

Hardware Design Specification

(HDS) and Software Design

Specification (SDS)

DS describes exactly how all

relevant URS demands for the

module is complied with

The DS is accompanied by drafts

using 2D/3D modeling that ensures

that the design can be produced

Each module contains a DS

The DS is specific TAG-, alarm-,

parameter-, data lists and sequence

diagrams

Detailed 3D modelling is made so

that production documentation can

be issued. All drafts in the DS are

replaced by final 3D models

Adjustment and calibration guidance

are detailed and finished

DS is completed

DQR is issued based on the DS

2D manufacturing base is created

based on the DS and production is

initiated

The SVM Method

From quotation to qualification

in 15 min

18

Quatation / Basis Design specification

URS to Design specification

Running in

Test / Qualification

Design (and programming)

AssemblyProject flow

19

URS to Design specification

All our machines are customized in close cooperation with our customers

to insure we always have uniform quality, we use

Modulized DesignOur machines are divided into Equipment Modules (EM) with individual

Design Specifications (DS)

Traceability matrixThe URS data is imported into a traceability matrix (TRM) and all

requirements are referenced to the relevant EM

A cross reference file is generated automatically into every DS for each

EM.

Every EM has its own DS and cross reference to the relevant URS data

20

Modulized Design – Equipment modules (EM)

We build our customized machines divided into modules,

Equipment Modules (EM)

Each module has a design specification and unique marking

also reflected in the URS reference

EM numbers are used throughout the machine layout, HMI

and documentation

21

Modulized Design – SVM Rules in dividing and naming

All module dividing and naming are based on PackML thinking.

E.G - EM04A_M1B0

22

Modulized Design – Filestructure and Database

All files are automatically created, named and linked to a central database

23

Modulized Design – Filestructure and Database

All files are automatically created, named and linked to a central database

24

From URS to DS

TRM

DS

Generated

automatically

URS Data

URS

reference to

DS EM06

25

From URS to DS

TRM

DS

URS

reference to

DS

describes

which

section of

the DS and

section of

the URS

reference is

complied

with

26

Quatation / Basis Design specification

URS to Design specification

Running in

Test / Qualification

Design (and programming)

AssemblyProject flow

27

Design – Data Entry

Tag tool – To minimize entry errors and time consumption

28

Design – Data Entry

Standardized module templates – Possibility of re-using ‘old’ modules

Messages

Parameters

29

Design - Collect indivually EM data to UN

EM01 EM02 EM03 … EMxx

UN01

EM01 EM02 EM03 … EMxx

UN01

Tool to collect and group unit data

30

Design - Collect indivually EM data to UN

UN tag list – Reference point for all systems

-vb macros used to sort and structure data for induvial systems

31

Design – UN taglist usage

UN tag list – Reference point for all systems

-vb macros used to sort and structure data for induvial systems

Design specifications

Drawings

Programs

Tag list

E.G. I/O tags ready to enter in PLC

32

Design – Tranforms excel data to usefull code

UN messages list – Reference point for all information's displayed to user

-vb macros / tools used to sort and structure data for induvial systems

33

Design – Tranforms excel data to ready to use code

3 simple steps to create alarms:

(1) create alarm structure (DB)

(2) create alarm conditions / Trigger (FC)

(3) Import alarms to HMI

34

Design – Tranforms excel data to ready to use code

(1) create alarm structure (DB)

This will re-structure

the data to fit to the

PLC program as a

source file

35

Design – Tranforms excel data to ready to use code

(1) create alarm structure (DB)

- using vb macro to create source files

36

Design – Tranforms excel data to ready to use code

a

Inset your own

conditions

(2) create alarm conditions / Trigger (FC)

b

c

37

Design – Tranforms excel data to ready to use code

(3) Import alarms to HMI

38

Design – Tranforms excel data to ready to use code

Alarms

Sequences

39

Design – Tranforms excel data to ready to use code

Draw → Run macro to create AWL fil → Import as ‘External source file’

80-90 % finished code

40

Design – Tranforms excel data to ready to use code

Alarms

Sequences

41

Quatation / Basis Design specification

URS to Design specification

Running in

Test / Qualification

Modulized Design (and programming)

AssemblyProject flow

42

Assembly – Stil using the same structure / names

Pick list for an

EM

Blue colour use

Design

Specification

in the

assembly

43

Quatation / Basis Design specification

URS to Design specification

Running in

Test / Qualification

Modulized Design (and programming)

AssemblyProject flow

44

Running In – Stil using the same structure / names

The structure of Equipment modules, are also used during running in

45

Quatation / Basis Design specification

URS to Design specification

Running in

Test / Qualification

Modulized Design (and programming)

AssemblyProject flow

46

Test plans – On the way to be ‘automatically’ created

Tool to generate test plans

(1) URS to TP

(2) Match URS-point to one or more keywords

(3) Import to Design specifications

47

Test plans – On the way to be ‘automatically’ created

The TRM is the starting point for all test plans

48

Test plans – On the way to be ‘automatically’ created

Test descriptions are put in to Design specifications

49

The Benefits

VISION – Standardization overall

-With the use of standardized platforms, modules and processes insuring the

quality and uniformity of all machines produced and lower the overall

engineering developing time.

+ One point of entry

+ Less errors

+ Uniform

+ Lead time

- Chance to slow down innovation

- Maintenance cost (tools)

The future

where are we heading

2017

51

The Future

GOALs - All code needed for a HW test is auto generated.

- Unique code is always structured the same way

using the same set for programming guidelines.

-

TOOLs - Clear interfaces

- More standardized code

- One main language (Structured text)

- More true to Omac / PackML

- Object orientated

- Written guidelines (Meaning How, not what)

-

52

The Future

BDS

Documents /

Data

”Kartotekskort”

med Stamdata

Function

DS

Design

Testplaner

HW test

FAT / SATSALG

Standard data

53

The Future

HW

Documents /

Data

”Kartotekskort”

med Stamdata

Functio

n

Standard modul data

Modul ref.

Mech

SW

Design Copy

PCS Tegninger

Evt. komponent

dok.

…

…

Parameter settings

Afsnit til Operatør manual

Program ”skal”

54

The Future

MANUEL

Documents /

Data

”Kartotekskort”

med Stamdata

Functio

n

Standard modul data

IN

HMI

ALARM

AUTO

RESET

BATCH

TØMNING

RPI

OUT

Std Interface,

navngivning osv.

UN

IQU

E

Std

. K

ode

Std

. Tem

pla

te

55

The Future

BDS

Documents /

Data

”Kartotekskort”

med Stamdata

Function

DS

Design

Testplaner

HW test

FAT / SATSALG

Standard data

How can we handle changes and updates in a standardized process

How can we ensure that the hole organization ‘accept’ the new way

Engineering Division

Thank You for Your Attention

Q&A?

www.svm.dk