Diofan Super B The best barrier for thermoformable packagingpmmi.files.cms-plus.com/PharmaEXPO/2014/files/Mon_12pm_Solvay.pdf · Diofan® Super B The best barrier for thermoformable

Diofan® Super B The best barrier for

thermoformable packaging Kirk Paisley

Sales Development Manager High Barrier Polymers

1.  Solvay Group Overview 2.  Diofan® PVDC: Proven Barrier Performance 3.  Diofan® Super B: the New Ultra Barrier

Solvay Specialty Polymers 2

Solvay: A Major Chemicals Player with Global Demand Growth Driven by Megatrends


Climate change

Resource scarcity

Next billion consumers

Health & well being

Market drivers Solvay’s strengths •  One of the top 10 worldwide largest

chemical players from developed markets

•  90% of sales in businesses ranking among the top 3 global leaders

•  Global presence with 40% of sales in fast growing countries

•  Diversified end-markets creating resilience through cycles

•  Differentiated innovation focused on sustainable development

•  Committed to operational excellence targeting best-in-class process efficiency

150 years of distinctive history


Ernest Solvay creates a technological breakthrough with the ammonia-soda process

1863 1880’s 1910s 1945 1978 2010-2011

Solvay is the first multinational industrial active simultaneously in the USA, UK, Europe

Solvay acquires several pharmaceutical companies

Solvay diversifies its activities: plastics, specialty polymers

Solvay sells pharma activities and acquires Rhodia

Solvay once again leads, inventing social housing and paid holidays

Solvay Focused on Fast-growing Regions


North America

25%

Europe

33%

Latin America 11%

Asia Pacific & RoW

31%

$11.3 bn Net Sales

$2,293 m REBITDA

117 Major Industrial Sites

29,400 Employees

15 Major R&I Centers

$327 m R&I expenditure

2013

Figures represent % of 2013 net sales (pro-forma ChemLogics sales) % evolution vs 2012

Multiple End Markets

Healthcare

Aircraft Automotive

Oil & Gas Alternative Energy

Construction

Industrial Membranes

Smart Devices Electricals & Electronics

Consumer Goods

Specialty Polymers at a Glance


Business Strengths

0040+ Proprietary Technologies 0300+ Commercial Employees 0450+ RD&T Specialists 1500+ Products 2700+ Employees Worldwide 2900+ Patents in Force 4000+ Customers

4 R&I centers 6 production sites

4 R&I centers 2 production sites

7 production sites

2 R&I centers

Net Sales 2013

28%

2%

40%

31%



Solvay: the Leader in PVDC for Pharmaceutical Blister Barrier for 45 Years


•  45 years of -  Experience in pharmaceutical packaging -  Market leadership -  Innovation -  Supply excellence -  Manufacturing excellence

45 years

History of Diofan® in Pharmaceutical Packaging

•  1953/54: Base coat / top coat concept established -  Diofan 220 D – base coat -  Diofan 180 D – top coat


Substrate

Diofan Base Coat(s) Diofan Top Coat

History of Diofan® in Pharmaceutical Packaging

1953 Development of base coat/top coat structures 1962 Development of blister packaging for pharmaceuticals 1966 Development of Diofan coatings on rigid PVC films 1969 Market launch of Diofan coatings on rigid PVC films for

pharmaceutical packaging 1978 Development of low-foaming Diofan dispersions 1985 Market launch of triplex structures using high coating weights

of Diofan (≥ 90 gsm) 1999 BASF and Solvay products harmonized under SolVin 2007 Launch of Diofan Super B, with the best balance of barrier

properties ever offered in transparent blister packaging


Diofan® PVDC: Strong Properties by Chemistry

11 Solvay Specialty Polymers

The co-monomer influences the properties •  Crystallinity •  Polarity •  Functionality •  Low melt T •  Low Tg

...and their benefits •  H2O vapor barrier •  O2 barrier •  Adhesion •  Heat sealability •  Thermoforming flexibility

Always a co-monomer!

Diofan®: Complete Barrier Protection

12

§  Aroma §  Off-odor, off-flavor

§  Gas (O2, CO2, etc.) §  Water vapor (H2O)

§  Microorganisms §  Oil, grease

Solvay Specialty Polymers

Blister film/foil solutions on the market…

A number of options are available:


•  PVC •  PP •  PETG •  APET •  CPET •  PVC/PE •  PVC/PCTFE •  PVC/PE/PCTFE •  PVC/EVOH/PCTFE •  PVC/PVDC •  PVC/PE/PVDC •  PP/COC/PP

•  PE/COC/PE •  PE/COC/PCTFE •  PETG/HDPE/PETG •  PVC/ALU/oPA (CFF) •  PE/ALU/oPA (CFF) •  APET/PVDC •  APET/PCTFE •  PETG/PCTFE •  PVC/PE/EVOH/PE/PCTFE •  PP/COC/PP/PCTFE •  PVDC/COC/PVDC •  PVC/COC/PVDC

Diofan®: The Most Widely Used Barrier Polymer for Pharmaceutical Packaging

World-Wide Barrier Blister Packaging: Total Volume ≈ 84 kton (Does not include PVC Monofilm)


PVC/PVdC 67%

PVC/PCTFE 7% Other

(PP, COC, etc.) 2%

CFF Laminates 24%

Pharma Manufacturer

Film Producer

Players in Barrier Blister Selection




Diofan® Super B: the Ultra Barrier Grade

17

Barrier level

Com

petit

iven

ess

High Barriers

Ultra Barriers

Diofan®

PVDC Diofan®

Super B COC

CFF

PCTFE


Diofan® Super B offers the best barrier in thermoplastics

18

3.3

15

33

~15

PCTFE, 102 µm + Diofan A736, 150 g/m²

PCTFE, 102 µm + EVOH, 20 µm

Diofan Super B, 240 g/m²

PCTFE, 102 µm


29

17

> 20

5.6

3.3

0.05


PCTFE, 51 µm + EVOH, 20 µm

PCTFE, 51 µm

20

17

9 8

9

9 0.05

1/WVTR (m²·d)/g @ 38°C, 90% RH

1/OTR (m²·d)/cm³ @ 23°C, 50% RH


Temperature impact is similar for Super B & PCTFE

19

0.01

0.1

1 20 25 30 35 40 45

PVC (250µm) / PE (25µm) / Super B/193D (130gsm) PVC (250µm) / PCTFE (51µm) (130 gsm)

WVT

r [g/

m²d

]

Temp[°C]


Relative humidity impact is similar for Super B & PCTFE

20

0

0.025

0.05

0.075

0.1

50 55 60 65 70 75 80 85 90 95

PVC (250µm) / PE (25µm) / Super B/193D (130gsm) PVC (250µm) / PCTFE (51µm)

WVT

r [g/

m²d

]

RH %


(130 gsm)

Yellowing under ICH has no impact on Barrier Level


Yellow Index and WVTr of Super B 120 gsm coated PVC film Evolution at 40°C & 75% RH

0

2

4

6

8

10

12

0 1 2 3 4 5 6 7 Aging time (month)

Yello

w In

dex

0 0,02 0,04 0,06 0,08 0,1 0,12 0,14 0,16 0,18 0,2

WV

Tr a

t 38°

C &

90%

RH

(g

/m²·d

)

Yellow Index WVTr at 38°C & 90% RH (g/m²·d)

Super B Enables Higher Pill Density in Blisters

No Curling Ø No Reinforcement Strip Ø Greater Pill Density


CFF SUPER B

Pill Density pills/m²

PCTFE

Diofan® Super B: the Lowest Environmental Footprint among Ultra Barriers


Global Warming Potential GWP [100 year kg CO2 eq]*

Data sources: Allied Development Corp. US LCI data for materials & processing only Equivalency for 1600 pills 1.5mm round

PVC

Diofan® Super B

PVC

PCTFE

0

1

2

3

250 µm PVC / 51 µm PCTFE

CFF: 25 µm OPA / 45 µm Alu foil /

60 µm PVC

250 µm PVC / 120 gsm Diofan® Super B

Other Functional Characteristics of Diofan® Super B are the Same as Standard Diofan® Grades

•  Seal integrity in the Triplex structure

•  Safe forming

•  Chemical resistance

•  Transparency

•  Same thermoforming tooling


Diofan® Super B in the Ultra Barrier Market Today

25

2012 2013 2014 2011

15%

0%

Market Share


Global Acceptance in Food & Pharma Environment


•  U.S.: Compliance with Food and Drug Administration (FDA) 21 CFR Part 170-199(1)

•  European Pharmacopeia

•  Diofan® approved for potable water distribution (Europe)

•  EU Regulation No 10/2011 on plastic materials and articles intended to come into contact with foodstuffs(2)

1) Compliance data for specific grades is available from your Solvay representative. 2) Including EU Regulation No 1282/2011

Diofan® Network


Diofan® Super B | Summary

•  Best in class in High and Ultra Barriers for total protection -  Excellent and safe barrier properties -  Excellent price/performance ratio -  Low environmental impact -  Compliant with regulatory requirements


Safety Data Sheets (SDS) are available by emailing us or contacting your sales representative. Always consult the appropriate SDS before using any of our products.

Neither Solvay Specialty Polymers nor any of its affiliates makes any warranty, express or implied, including merchantability or fitness for use, or accepts any liability in connection with this product, related information or its use. Some applications of which Solvay’s products may be proposed to be used are regulated or restricted by applicable laws and regulations or by national or international standards and in some cases by Solvay’s recommendation, including applications of food/feed, water treatment, medical, pharmaceuticals, and personal care. Only products designated as part of the Solviva® family of biomaterials may be considered as candidates for use in implantable medical devices. The user alone must finally determine suitability of any information or products for any contemplated use in compliance with applicable law, the manner of use and whether any patents are infringed. The information and the products are for use by technically skilled persons at their own discretion and risk and does not relate to the use of this product in combination with any other substance or any other process. This is not a license under any patent or other proprietary right.

All trademarks and registered trademarks are property of the companies that comprise the Solvay Group or their respective owners.

© 2014, Solvay Specialty Polymers. All rights reserved.

www.solvay.com

Documents

Diofan Super B The best barrier for thermoformable packagingpmmi.files.cms-plus.com/PharmaEXPO/2014/files/Mon_12pm_Solvay.pdf · Diofan® Super B The best barrier for thermoformable