stevanato group brand structure - sesam worldsesam-world.com/_pdf/sesam-121/05-svm.pdf · ·...
TRANSCRIPT
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