Pharmtech 2014

SGD Pharmacy DivisionPrimary packaging for healthcare

Glass Vials for Pharmaceuticals Toward Compliance and High Quality

Ekaterina Lysenko

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SGD Group Sales in 2014 : 564 million €

• Perfumery - Cosmetic & others : 282 M€

More than 1 Billion perfume bottles manufactured per year

• Pharmacy : 235 M€

More than 2 Billion pharmaceutical vials manufactured per year

• VGE & Other : 47 M€

Over 4 700 employees : 1 out of 2 employees works outside France

Worldwide Leadership : A unique worldwide footprint

Regular industrial investments : more than 100 M€ invested between 2010 and 2013

Our Shareholders

• Oaktree Capital Management Ltd (80%) – Investment Company

• Pool of lenders (20%)

SGD Key figures

Injectables30%

Infusion30%

Oral 30%

Nasal5%

Other5%

A worldwide leader in parenteral packaging

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SGD Pharmacy Division, a unique worldwide footprint

Sao Paulo

10 commercial agencies6 manufacturing sites

Chile

New-York MilanBarcelona

ParisKipfenberg

Guangzhou

Shanghai

Mumbai ZhanjangCogent Glass

Pharmacy Vials

Mers

Sucy

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Product portfolio

From standard design and neck finishes to tailor-made solutions for specific applications. Satisfying a wide application base such as :

U-Save ® vials with molded internal conical bottom

EasyLyo ® “survivor vials” for lyophilization

Mix-O-Vials for multi-component packages

All glass types

Type I – Neutral Glass (Borosilicate glass)the exclusive low aluminum level Asolvex®

Type II

Type III

And colors

Flint

Amber

Sodalime glass

Injectables

Infusions

Syrups

Droppers

Diagnostics

Nasal Spray

Lyophilization

Tablets

Sprays

Our product portfolio offers a wide range of moulded glass products for a large type of applications :

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Plastic coating and printing

a protection from light

multiple colors and coating options

SGD Pharmaceutical Glass offers products and proces s services

Technical customer service

assisting clients in running SGD glass

depacking machines

Siliconization

protects delicate molecules

prevents product deposition on the surface

ensures dispensing up to the last drop

SGD Industrial tool : think global act localEnsuring procurementSecurity of supply

Securing your supply chain is vital. SGD offers crossed-safety solutions between its facilities to ensure continuous supply.

For clear glass Type II-III

For amber glass Type III

For Type I

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Sucy Kipfenberg Zhanjiang

Sucy Brazil

Mers F2Mers F4

Back up organization

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Vials/Bottles per day : 4.2 M

Type II & III

Flint & amber glass

Antibiotics, syrups, droppers

Plastic coated aerosols

2 furnaces including new amber type III furnace environmentally friendly

Certified ISO 15378

Sucy-en-Brie (France)A plant fully dedicated to Pharmacy

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Vials/Bottles per day : 1 M

Type I Flint & Amber glass

Center of excellence for Type I

2 furnaces dedicated for Type I

Certified ISO 15378

Complete upgrade of cold end in ISO 8 clean room

Mers-Les-Bains (France) A plant dedicated to Type I Glass

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Vials/Bottles per day : 1.8 M

Type II flint glass

Type III flint glass

1 furnace

Certified ISO 15378 & ISO 14001

Kipfenberg (Germany)Center of excellence for Infusion bottles type II

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ISO 15378• The new international standard for primary

pharmaceutical packaging

• Combines ISO 9001 + GMP

All our pharmaceutical sites are certified2005 Kipfenberg

2007 Sucy-en-Brie

2007 Mers-les-Bains

2007 Verreries de la Somme (Siliconization)

2012 Zhanjiang

Advanced & Certified Quality System

Evolution and improvement between 2012 and 2014� 2012

�Line 211 10DG 4" ¼ � Line 236 10TG 5"�New electrical Equipment ( Shears, gobs, pushers…)�Line 236 New control machines

12-camera body controlMulti-camera (rim + bottom )

�233 12-camera machine doubled

� 2013� The cold-End is not any more under the responsibility of the Hot-

End� Cold-End management� Line 221 4-camera body machine � 12-camera

� 2014�Line 221 (Multi-camera (rim + bottom + mold reader)

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To check non transparent defects

12-CAMERA SIDE WALL INSPECTOR

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New Furnace 3

Draining of old furnace

Destruction of the furnaceRoof elevation

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New Furnace 3

New structure of the furnace

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Bottero IS machine

First bottles producedMachine installation

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New state-of-the-art SGD type I glass plant

SGD Group: a market-driven approach focused on customer needs

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Producing more than 3 billion glass products each year, and after a 4 year – 200

M€ investment program, SGD is a market leader in glass for the pharmaceutical

and cosmetics industries.

The two sectors increasingly have their own distinctive market dynamics,

industrial processes and client requirements

As a way to focus on the market’s changing demands and evolving client needs,

SGD Group has decided to separate its business activities

For pharmaceutical glass: planned construction of a brand new plant

for Type I Glass, to become fully operational in 2015.

Managed by a highly experienced team,

the project respects all actual compliance and

potential regulatory constraints and compliance

(including FDA requirements)

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Mers plant

New Type I

site

~6,5kms (~4 miles)

SGD Pharma: planned new pharmaceutical plant

NEW TYPE I SITE: green-field site covering over 10.000m²

SGD Pharma: planned new pharmaceutical plant

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3D layout of future plant

Pharmaceutical Glass Containers SegmentationChemical properties constraints, applications and s izes

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Innovation is the role of SGD R&DMain areas of research :

�Glass formulation and melting

�Forming and tempering

�Mechanical, optical and chemicalproperties

�Surface treatments, internal and external

�Inspection equipment

What is EasyLyo ® ?

2012

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Conception of EasyLyo ® range

�Asolvex ® Type I glass

�Reduction of glass vial weight :• more bottles per tray• improved heat transfer• reduction of Lyo cycle duration (depending on drug c ycle)

�Bottom reduced push up, minimum engraving

�Radius on the low part of the body (Heel)

�Opening of the neck : controlled up to 7.5mm depth

Optimized design

Specially designed to comply with the specific requ irements of the lyophilization process

� Flat base optimizing heat transfer� 30 % reduction of the vial weight (improved glass d istribution)� Improved durability thanks to a better distribution of the glass� Marked shoulders to improve the filling� Standard 20 mm ISO neck for compatibility with all closures and

reconstitution systems on the market (100% controll ed on 7.5 mm depth)

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Proven performances

Increased resistance to breakage thanks to the opti mized design of the vial :

� 5 to10 times more resistant than a standard tubing vial in terms of vertical load resistance (pressure exerted during t he stoppering phase in the lyophilizator chamber)

� 2 times more resistant in terms of the radial loadresistance (pressure exerted during the loading/unl oadingof the lyophilizator)

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Technical study 1Dr Gieseler - University of Erlangen

Achievement : Equivalent heat transfer coefficient

� The team led by Dr Gieseler of Erlangen University i n Germany evaluated the EasyLyo vials for the main lyophilizati on parameters, such as heat transfer coefficient.

� The first results of this study have been published in the European Pharmaceutical Review.

� EasyLyo vials do not exhibit any major difference in terms of heat transfer coefficient compared with premium tubing g lass like TopLyofrom Schott

� Added value for customer : potentially no need to modify the freeze drying cycle when using EasyLyo vials against tubing vials

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Technical study 2Dr Trappler - Lyophilization Technology

Achievement : Excellent pressure resistance

� Dr Ed Trappler of Lyophilization Technology in the USA looked at the main breakage parameters of the vials during lyophi lization, such as mannitol concentration and fill volume.

� The definitive results were published in June 2010 and are very favourable. They clearly demonstrate the superiorit y of the EasyLyovials in terms of resistance (pressure exerted duri ng the primary drying phase in the lyophilisation chamber).

� In fact, where 100% of tubing glass vials and 80% o f standard moulded glass vials will break, only 10 to 20% of EasyLyo vi als do so.

� Added value for customer : These results are extremely significant, in particular for the packaging of certain cytotoxic m olecules where container breakage can be hazardous to healthcare pr ofessionals.

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The EasyLyo ® range

capacity 5 ml 10ml 20ml 25ml 30ml 50ml 100ml

reference 03360 03331 20563 20572 20561 20560 20565