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EZ-Ecopack: a new sterile packaging connection system based on ready-to-fill standard formats for glass primary packaging Speaker: Alessandro Morandotti (R&D Glass Division Technical Customer Care) Pharmapack | Paris, 12 February 2014

EZ-Ecopack: a new sterile packaging connection system based … Pharmapack_Final... · 2014-10-07 · EZ-Ecopack: a new sterile packaging connection system based on ready-to-fill

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Page 1: EZ-Ecopack: a new sterile packaging connection system based … Pharmapack_Final... · 2014-10-07 · EZ-Ecopack: a new sterile packaging connection system based on ready-to-fill

EZ-Ecopack: a new sterile packaging connection

system based on ready-to-fill standard formats for

glass primary packaging

Speaker: Alessandro Morandotti (R&D Glass Division Technical Customer Care)

Pharmapack | Paris, 12 February 2014

Page 2: EZ-Ecopack: a new sterile packaging connection system based … Pharmapack_Final... · 2014-10-07 · EZ-Ecopack: a new sterile packaging connection system based on ready-to-fill

OMPI Today

2

Who we are:

• Indipendent company

• Over 60 years of history

• 5 Plants for glass primary packaging

• 2 plants for Engineering (converting/inspection)

• Global capacity: 4 bn containers

• Revenue 2013: 240 MM Euro (+16% vs 2012)

• Investments 2013: 40 MM Euro

• Employees: 1800

Key Data:

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Company Strengths (Pharma and Engineering)

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Leader in manufacturing

cartridges for insulin

Full portfolio (ampoules,

cartridges, syringes, vials)

from glass tubing

Full Range of Sterile

products (vials,

cartridges and syringes)

branded EZ-fill

Innovative solutions for

Biotech

Leader in converting

technology (SPAMI) Full range of Automatic

Inspection Machines

(Optrel and InnoScan)

100% Dimensional and

Cosmetic Controls by

Camera

Page 4: EZ-Ecopack: a new sterile packaging connection system based … Pharmapack_Final... · 2014-10-07 · EZ-Ecopack: a new sterile packaging connection system based on ready-to-fill

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Transferring of sterile material in sterile environment is a critic aspect of the parenteral manufacturing process.

4

Sterile

containers

Rabs, Isolator

(sterile area)

Page 5: EZ-Ecopack: a new sterile packaging connection system based … Pharmapack_Final... · 2014-10-07 · EZ-Ecopack: a new sterile packaging connection system based on ready-to-fill

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Small components (rubber closures) are introduced through Rapid Transfer Port, not available for big size materials.

5

Rabs, Isolator

(sterile area)

Co

urt

esy o

f S

art

oriu

s S

ted

im B

iote

ch

Gm

bH

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Primary Packaging need to be decontaminated before feeding inside an isolator

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Rabs, Isolator

(sterile area)

Decontaminator

VHP | E-Beam | Other

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The Critical Point: Actual Rapid Transfer Port does’t allow the transfer of Nest and Tub

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Page 8: EZ-Ecopack: a new sterile packaging connection system based … Pharmapack_Final... · 2014-10-07 · EZ-Ecopack: a new sterile packaging connection system based on ready-to-fill

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..

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Page 9: EZ-Ecopack: a new sterile packaging connection system based … Pharmapack_Final... · 2014-10-07 · EZ-Ecopack: a new sterile packaging connection system based on ready-to-fill

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..

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Page 10: EZ-Ecopack: a new sterile packaging connection system based … Pharmapack_Final... · 2014-10-07 · EZ-Ecopack: a new sterile packaging connection system based on ready-to-fill

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The same standard packaging as for traditional «pallet» scheme for prefilled syringes.

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Tub

Steri

Bigbag

Transfer Port

connected with

the one of the

Isolator/RABS

Tyvek sheet to protect the

connection and avoid

external contaminations

(inside the akylux box

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..

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Transfer port Transfer port

Page 12: EZ-Ecopack: a new sterile packaging connection system based … Pharmapack_Final... · 2014-10-07 · EZ-Ecopack: a new sterile packaging connection system based on ready-to-fill

EZ-Ecopack: a lean process

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Rabs, Isolator

(sterile area) Steri Bigbag

(sterile bag)

Tub

Page 13: EZ-Ecopack: a new sterile packaging connection system based … Pharmapack_Final... · 2014-10-07 · EZ-Ecopack: a new sterile packaging connection system based on ready-to-fill

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The same standard packaging as for traditional «pallet» scheme for prefilled syringes.

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Page 14: EZ-Ecopack: a new sterile packaging connection system based … Pharmapack_Final... · 2014-10-07 · EZ-Ecopack: a new sterile packaging connection system based on ready-to-fill

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The same standard packaging as for traditional «pallet» scheme for prefilled syringes.

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Page 15: EZ-Ecopack: a new sterile packaging connection system based … Pharmapack_Final... · 2014-10-07 · EZ-Ecopack: a new sterile packaging connection system based on ready-to-fill

EZ-Ecopack: video of the process

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Page 16: EZ-Ecopack: a new sterile packaging connection system based … Pharmapack_Final... · 2014-10-07 · EZ-Ecopack: a new sterile packaging connection system based on ready-to-fill

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EZ-Ecopack: In summary

• EZ-Ecopack is a smart and valuable

solution to feed primary packaging

inside aseptic environment.

• EZ-Ecopack allows to reduce:

• initial investments,

• waste,

• operations costs (energy, ..),

• validation time/costs,

• maintenance costs,

• space.

• Contact us to receive more

information about EZ-Ecopack!