Masco Group overview

Masco Group overview

General Presentation

July, 2017

CONFIDENTIAL AND PROPRIETARY

Any use of this material without specific permission of Masco is strictly prohibited

Masco Group

Contents

▪ Masco Group at glance

▪ Only Masco can do it!

▪ Olsa Group

▪ Olsa activities

ADVANCED PROCESSING SOLUTIONS|Masco Group

AROUND THE CORNER, AROUND THE WORLD 1

Masco Group |

Masco Group encompasses different companies active in engineering,

manufacturing and consulting to the pharma and cosmetic industry…

Group structure

MascoS.r.l.

StilmasStilmas Olsa

Shanghai Stilmas US Russia France Olsa US

Co

Stilmas

S.p.A.Olsa S.p.A. DOC S.r.l

Description

▪ The Masco

Group has its

Headquarters in

Italy, but several

different

subsidiaries

around the

world:– China– US

– Russia

– France

▪ The Group

positions itself

as the leader in

providing

engineering

solutions to

Tier1 clients in

the Pharma and

Cosmetic

industry

AROUND THE CORNER, AROUND THE WORLD 2

ADVANCED PROCESSING SOLUTIONS

…where it’s recognized as advanced engineered solution provider for all

Tier 1 pharma and cosmetic producers

1 Footnote

Client sampleDescription

▪ The Group’s

reputation for

reliability and

excellence has

allowed it to

establish strong

relationships

(+10.000

installed units)

with leading

pharma &

cosmetic

companies

▪ The Group is

not dependent

on any single

client nor a

limited number

of clients

▪ Customer

satisfaction

ILLUSTRATIVE

ADVANCED PROCESSING SOLUTIONSAROUND THE CORNER, AROUND THE WORLD

|Masco Group 3

Contents


|Masco Group 4



▪ Olsa Group

▪ Olsa activities

Key distinguish factors

▪ Masco Group is the only one in the worldbeing

able to grant an:

− Integrated approach from basic engineering

to process validation

− Deep experience and internal know-how from

clean utilities to production

− Strong knowledge of the different production

processes (solids, semisolids, orals and

sterile products)

− High flexibility to fulfil the customerneeds

and expectations

− Sure execution

Main clientbenefits

▪ Experienced, qualified and knowledge interface

being able to provide advise to the client not only

on the Group main competences, but also broadly

on the entire process flow

▪ One single contractor with full responsibility

▪ Direct ownership of the equipment and

technologies supplied with their full control

▪ The same Quality approach and QualitySystem

along all the value chain

▪ Full GMP approach

From engineering to execution


|Masco Group 5

Masco is distinguishing in the market for managing complex integrated

projects starting from basic design to validation…

Example of some integrated project

xxx:

▪ Amount: €32mln

▪ Year: 2012-2013

▪ Scope: vaccine

production

xxx:

▪ Amount: €4mln

▪ Year: 2011&2014

▪ Scope: LVP

xxx:


▪ Year: 2014

▪ Scope: LVP, Onco,

API products

xxx:

▪ Amount: €9mln

▪ Year: 2014

▪ Scope: Insuline

xxx:

▪ Amount: €4mln

▪ Year: 2014

▪ Scope: Steriles

xxx:


▪ Year: 2013&2015

▪ Scope: LVP

xxx:


▪ Year: 2015

▪ Scope: LVP, Onco

xxx:


|Masco Group 6

▪ Amount: €2.7mln

▪ Year: 2014

▪ Scope: Steriles

…and this approach is more and more appreciated by clients all over the

world

In particular Stilmas and Olsa have an installed base of ~€70mln in the last

10 years only, in the enlarged CIS area

Description

▪ Stilmas and Olsa have an

historical strong presence in all

the CIS area with an installed

base of more than €70mln of

which:– Olsa €29.5mln

– Stilmas €38mln

▪ The majority of Olsa

equipment are for liquid

sterile products (i.e., approx.

80%) while rest is for semi-

solids (i.e., approx. 15%) and

solids (i.e., approx. 5%)

▪ Turn-key projects are the

core business for Stilmas and

Olsa supplies

▪ Olsa and Stilmas have a

direct presence in the area

with ample coverage of the

market from commercial till

aftersales

30

38


|Masco Group 7

Project amount in CIS area

Euro mln

Olsa Stilmas

68

Total

Contents


|Masco Group 8



– Case study BBraun

▪ Olsa Group

▪ Olsa activities

Specifically:

▪ Stilmas supply encompasses

− PW Production Systems

− No 2 Cationic / Anionic lines(36.000l)

− Purification System EDI/ Filtration 0.2 based

34.000 l

− PW Storage Tank 20.000 l

− PW Loop 70.000 l/h – 700m – 23 UP

− WFI generator; MS5010 (15.000l/h)

− WFI Storage Tank 100.000 l

− WFI Loop 1.000 m – 120.000 l/h – 25 UP

− 6 Heat Exchanger 1.200.000 Kcal/h

− Pure steam generator PSG 1500 -2.200 Kg/h

− PS distribution system – 500 m - 30 UP

− Clean Compressed air generation 6.000Nm³/h

− Clean Compressed air distribution System 83 UP –

5 filtration stations – 6 redaction systems – 270 m

− Vent Lines - 380m

− Vacuum generation and distribution - 180m

Project description

Olsa and Stilmas were awarded €10mln turnkey project for clean utilities

and sterile product preparation (1/2)

Masco Group was awarded the supply of the entire clean utilities, distribution loops, preparation room, filtration room,

SCADA systems for a LVP project, involving the installation of :

Specifically:


|Masco Group 9

▪ Olsa

− 5 preparation lines from 15k lt to 30k lt

− 5 filtration skids with 2 pre-filters followed by

sterile filters

− ATEX execution

− Powder handling room

− LAF system, manual loading system and

weighing system

▪ DOC supply encompasses

− FAT/SAT/IQ/OQ protocols

− IQ/OQ execution

− SW development

Olsa and Stilmas were awarded €10mln turnkey project for clean utilities

and sterile product preparation (2/2)

Manpower deployment

▪ During the project, manpower utilization

has been massive and up to now the

following hours have been spent:

− Engineering: 9.000 hrs

− Project management: 3.200 hrs

− Electrical design: 1.100hrs

− SW design: 3.300 hrs

− SCADA design: 2.700hrs

− Site construction: 10.900hrs

− Validation: 3.000 hrs

Pr etreatm ent AB R 008A Pr etreatm ent AB R 008B

S.N .9040 – 9160 S.N .9041 - 9161

P&ID Z1 P&ID Z2

Process FlowDiagram

Customer: Bio-ManguinhosProject Name: CIPBRContract Number: 13/2011Project Location: RiodeJaneiro, BRAZIL

Document No: 3141-PFD-Z1÷Z65Rev: 9, 05/06/2012Internal Job No: 11/C041

LI NE A LA D O A

PS distribut ion

Line LV P0 0 8A

P&I D Z 6 4

LI NE A LA D O B

PS distribut ion

Line LV P0 0 8 B

P&I D Z 6 5

G VP 01 G VP008A

PSG 4000Gasbus ter

S.N . 9148 - 9149

P&ID Z61

G VP 02 G VP008B

PSG 4000Gasbus ter

S.N . 9150 - 9151

P&ID Z62

G VP 03 G VP008C

PSG 4000Gasbus ter

S.N . 9152 - 9153

P&ID Z63

ROOM 6 0 12

ROOM CT A

O R -01 G AP008A O R -02 G AP008B O R -03 G AP008C O R -04 G AP008D

BR O 151 + ED I BR O 151 + ED I BR O 151 + ED I BR O 151 + ED I

S.N . 9042 - 9043 – 9044 S.N . 9045 - 9046 - 9047 S.N . 9048 - 9049 - 9050 S.N . 9051 - 9052 - 9053

P&ID Z3 P&ID Z4 P&ID Z5 P&ID Z6

TQ110- PW TK 10 m 3 TQP008A

M ain Loop 01

S.N . 9065 – 9066

P&ID Z7

S y st e m 1 1 0PW Loop - M a i n Loop 0 1 LPW0 0 8 A

P&I D Z 8

G D F E CB

8 8 8 8 88

0 0 0 0 00

0 0 0 T 0T

00

aP a P P P PP

PP d

sQ n 8 Q 0 Q D 4 Q

D6 Q

T2

Q o4T

7T T T S T

T s 6

a T 7 I 7 7 P 7r 0P

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0i

³ e 9 9 ³ 9 1 ³ 9 5 ³ 7 ³ 9 3³

9D P9

s 91 1 1 a 1 m lRZ n

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-Z

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mt --

nI la 7 V i9 / 3 5 t 1 0

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B 7 D4 o

63

73

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r D D/

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IK C 0

IK 0 I K o 0

Ip 0o

9&

Tf &

T o 9& S

&& K

o 9&

T r 9 T 9 T p 9pe . P p . P o o . P

To .

P

i . P . PW N Wn

N W t N W p N W t NW

L Nt t i ro . . . i i . .

Pt

PI

P o Pt .

Pr

n- o S - S -

tS - o S - E S P

iS

5r

1 3o

4t

2-

a0

P0 0

r0

o0

9

1 1 1P

1 P 10 M

r

Q Q Q Q Q1

T T T T TQ T

S y st e m 1 0 5 S y st e m 1 0 1 S y st e m 1 0 3 S y st e m 1 0 4 S y st e m 1 0 2 S y st e m 1 0 9

PW Loop PW Loop PW Loop PW Loop PW Loop PW Loop -

LPW0 0 8 G LPW0 0 8 D LPW0 0 8 F LPW0 0 8 E LPW0 0 8 C M a i n Loop

P&I D Z 2 0 P&I D Z 1 2 P&I D Z 1 6 P&I D Z 1 8 P&I D Z 1 4 Stills &

Na OH

LPW0 0 8 B

P&I D Z 1 0

ROOM 2 0 7 2

D E 01 D TL008A D E 02 D TL008B D E 03 D TL008C

M S 3005 H PS- L M S 3005 H PS- L M S 3005 H PS- L

S.N . 9085-9233 S.N . 9086-9234 S.N . 9087-9235

P&ID Z21 P&ID Z22 P&ID Z23

TQ209- W FI TK 7 m ³ TQW 008A

M ain Loop 1

S.N . 9100 - 9101

P&ID Z24

S y st e m 2 0 9WF I Loop - M a i n Loop 1 WF I0 0 8 A

P&I D Z 2 5

C B E D F8 8 8 8 80 0 0 0 00 0 0 0 0

W W W W WT

QT 5

Q P 9

Q 3

Q 7 Q 1

TP

0 T D

0 T 1 T 1 T s

2

³ 1 6 ³ 1 8 ³ T 1 0 ³ T 1

2 ³ a 1 4D 9 a 9 9 P 9

9m - 2

m n - 2

m P - 3

m - 3

m n - 3

n Z D 6 Z a Z4 i 8 Z D 2 Z i 04 o 6

t3 3 1 4 r

r 0D

e 0 D

I1D

s 1 D e

2 DK e 1

I K o 1

I K F 1

I K u

I K t 1

If r 9

T r 9

& T p 9

& T P 9

& T i & T c 9

&e P I o N

P I C N

P I V N

P I a N

P. . . . .

t N rI F . F t . F . F . F B.n i

I S r S SW W EW S

W S W

- - - - -1 2 3 4 50 0 0 0 02 2 2 2 2

Q Q Q Q Q System 205

T System 201

T System 202

T System 203

T System 204

T WFI LoopWFI Loop WFI Loop WFI Loop WFI Loop

S.N.9122-S.N.9106- S.N. 9110- S.N.9114 - S.N. 9118-

9123-9124-9107 9111 9115 9119

9125W FI008C W FI008B WF I0 0 8 E WF I0 0 8 D

W FI008FP&ID Z27 P&ID Z29 P&ID Z31 P&ID Z33 P&ID Z35

O R -05 G AP008E O R -06 G AP008F O R -07 G AP008G

BR O 151 + ED I BR O 151 + ED I BR O 151 + ED I

S.N . 9054 - 9055 - 9056 S.N . 9057 - 9058 - 9059 S.N . 9060 - 9061 - 9062

P&ID Z 41 P&ID Z42 P&ID Z 43

TQ111- PW TK 10 m ³ TQP008H

M ain Loop 02

S.N . 9067 - 9068

P&ID Z44

S y st e m 1 1 1

PW Loop - M a i n Loop 0 2 LPW0 0 8 H

P&I D Z 4 5

IJ K

88 8

00 0

00 0

PP T P

Q 0 Q P 2 Q

B 4T

T8 T D 8

Ts 8

0 0 o 0³

P 9 6 ³ B 9 8 ³ v 9 0m D -

4 m s -

4 m

t 5i

Z o Zc –

Z7

A 9 3 i 1 5 a 3s

7 D e 8 D e 8 DK

o 0 I K

M 0 I K

R 0 IT

i 9 & T 9 & T 9 &/ /e . P . P PROOM 6 0 10 W

M N W P N WP

N.P .P V

.P V

.-

S - S - S6

7 G 8G

00 0

11 1

QQ Q

TT T

S y st e m 1 0 6 S y st e m 1 0 7 S y st e m 1 0 8PW Loop PW Loop PW Loop

LPW0 0 8 I LPW0 0 8 J LPW0 0 8 KP&I D Z 4 7 P&I D Z 4 9 P&I D Z 5 1

D E 04 D TL008D D E 06 D TL 008F D E 05 D TL008E

M S 2005 H PS M S 2005 H PS M S 2005 H PS

S.N . 9088-9236 S.N . 9090-9238 S.N . 9089-9237

P&ID Z 52 P&ID Z54 P&ID Z 53

TQ210- W FI TK 10 m ³ TQW 008G

M ain Loop 2

S.N . 9102 - 9103

P&ID Z 55

S y st e m 2 1 0

WF I Loop- M a i n Loop 2 WF I0 0 8 GP&I D Z 5 6

H 8I

8 0ROOM 6 0 1 1 0 B 0

0 7W

2 W

1 Q 0Q

9 T 4T

1–

³ 99m

A 7 m B ÷ 5³ A

75

s Z0 s 2

Z 4o

9o 1D K e

3 Di1 i

9 1I

Ke I T

M 9&

- & IT M .

P6 P F

NF 2

W.

I1 - S

W 97System 206-B

- . 06

N2

WFI Loop 0 .2 S

QS.N. 9128,

QT System 207

9129, 9130, T WFI Loop

9131, 9132, System 206-A

S.N. 9141, 9142,

9133, 9134, WFI Loop

9143, 9144, 9145,

9135, 9136 S.N. 9137,

9146, 9147WF I0 0 8 H B 9138

W FI008IP&ID Z58 WF I0 0 8H A

P&ID Z60P&ID Z58


|Masco Group 10

As well as all the pre-treatment…


|Masco Group 11

As well as PW generation…


|Masco Group 12

As well as new engineering design philosophy (BIM)…


|Masco Group 13

As well as new engineering design philosophy (BIM)…


|Masco Group 14

As well as complete site yard capability.


|Masco Group 15

While Olsa supplied the entire preparation room including filtration

platforms and skids


|Masco Group 16

The entire system is overarched by a SCADA enabling automatic operation

and recipes management

Description

▪ Internal

automation Group

developed a

complete SCADA

system being able

to control and

register all

parameters from

generation up to

distribution and

preparation

▪ A set of fully

flexible recipes has

been created to

guarantee complete

flexibility of the

equipment, having

the possibility to

modify all

parameters of the

different recipe

▪ The architecture

encompasses 25

HMI, 1 SCADA, 3

CBADVANCED PROCESSING SOLUTIONSAROUND THE CORNER, AROUND THE WORLD

|Masco Group 17

Contents


|Masco Group 18



▪ Olsa Group

▪ Olsa activities

During last years Olsa has shown a continuous growth also thanks to the

substantial investment performed…

Description

▪ Olsa has almost 70

years of history

during which it has

expanded its footprint

globally with offices

and production sites

in Italy & France and

commercial offices in

US

▪ During last 4 years

Olsa invested

significantly to built-

up state of the art

facilities in France, in

Italy and US

▪ Olsa is experiencing

continuous growth

thanks to these

“model factories” and

the possibilities for

clients to test our

equipment with their

products in dedicated

laboratories at our

premises

1959

Olsa establishes Olsa Sa

in Paris’ suburbs, with the

aim to serve the fast

growing French market

2004

Masco acquires Olsa

SpA and its French

subsidiary

2005 2006

Olsa S.p.A.

establishes

Olsa USA

New management in

the organization at

the end of2005

2012 2016

Eng. Bertuzzi set-up

Olsa S.p.A. for the

design and

manufacture of

equipment for the

pharmaceutical and

cosmetic industry

Olsa France builds-

up a new facility

Olsa builds-up a

new facility

1947 2016

New facility

in USA


|Masco Group 19

Semi-solid products

… and to its unique abilities in engineering and executing customized

equipment for liquid, semi-solids and solid production

Liquid products

▪ Product range: from 3lt up to

15klt

▪ Applications: ointments,

suppositories, emulsions, gels,

suspensions, soft capsule

▪ Sectors: Pharma andcosmetic+

Solid products

▪ Product range: very different

set of products from vacuum

dryers, dry filters and hot air

hovens

▪ Applications: API production,

powders, solid and liquid

separation and drying under

vacuum

▪ Sectors: Pharma, chemicaland

fine chemical

+


|Masco Group

▪ Product range: from 50lt up to

50klt

▪ Applications: blood derivatives,

preparation of sterile liquid

solutions, injectable solutions,

eye-drops, syrups, aerosol,

human and animal vaccines,

enzymes

▪ Sectors: Pharma and Biotech

1 2 3

Liquids products


|Masco Group 21

Within the liquids family we consider all

products having a viscosity lower than or equal

to 500 cPs

❖ A solution is a homogeneous mixture composed of only one

phase

❖ A suspension is a heterogeneous mixture containing solid

particles that are sufficiently large for sedimentation

❖ A dispersion is a system in which particles are dispersedin

a continuous phase of a different composition (or state)

❖ An emulsion is a mixture of two or more liquids that are

normally immiscible (unmixable or unblendable).

1

Liquids products


|Masco Group 22

Sterile Pharmaceutical

Products

➢ Injectables SVP- Vaccines

- Blood Derivatives

- Antibiotics

- Cytotoxic

- Anesthetics

- Biotech (Recombinant/MAB)

➢ Injectables LVP- LVP

- Dialysis Solutions

➢ Ophthalmics- Eye Drops

- Cleaning and Disinfectant

Non Sterile Pharma,

Cosmetic and Food

➢Syrups

➢Aerosols

➢Mouthwash solutions

➢Lavage solutions

➢Vitamine solutions

➢Cosmetic oils and emulsions

1

BioProcess

Bioreactors:

From2 to 30 LitersLab Scale

(Modular)

Pilot Scale From 40 to 200 Litres

Industrial Scale Larger 200

Applications: Hormons, Vaccines (Human and Animal),

Antibiotics, Monoclonal Antibodies, Recombinant

1


|Masco Group 23

MULTIPURPOSE STERILE PLANT


|Masco Group

Liquids products1

Semisolid


|Olsa 25

2

CategoryOintment

(Single phase)Sterile and non sterile

Creams (multi phases)

Sterile and non sterile

Gels

(single phase)Sterile and non sterile

Paste Non sterile


|Olsa 26

Semisolid2

Compact On LegsCustomized

Skid Execution


|Olsa 27

Semisolid

Range of vessel configurations

2

Range of vessel configurations

OLSAMIXSPEEDYCREAM

SPEEDYMIX

Semisolid


|Olsa 28

2

N°2 SPEEDYMIX 5000 Liter production lines

Models / Features


|Masco Group 29

Semisolid2

Static

Tray Dryers Rotary Dryers

Olsa Vacuum Dryer solutions

Dynamic

Dryers

Solid


|Masco Group 30

3

DrymixSolid


|Masco Group 31

3

Documents

Masco Group overview