Primary Packaging for Sensitive Parenteral Formulations

IV bagContaining proprietary cyclic olefin polymer technology (“NI”), MediTect
products combine an unparalleled level of chemical compatibility andsorption resistance with an ultra-low extractables profile.
These properties provide product integrity and help maximize theshelf-life for the most demanding applications.

Customizable to Multiple
Sizes and Configurations

Prototypes and Samples
Readily Available

Non-PVC Containing

Compatible With Gamma
Irradiation or Autoclave
Sterilization

TMCombining the storage stability of glass with the flexibility of plastic

Ultra-low interaction
Potential extractables from packaging materials?

Sorption of active ingredients
to packaging surface?

SolvedSolvedInnermost NI typeInterlayer NI type

Ink (printing)Ink (printing)Ink (printing)Ink (printing)Ink (printing)Ink (printing)

Oligomers
Oligomers
Oligomers
Low weight
Low weightmolecules
molecules
Lowweight
molecules
Residual
Residual
solvents
solvents
Residual
solvents
MetalMetalIons
Ions
Metal Ions

Oligomers
Oligomers
Oligomers
Low weight
Low weightmolecules
molecules
Lowweight
molecules
Residual
Residualsolvents
solvents
Residualsolvents
MetalMetalIons
Ions
Metal Ions

Mechanism of sorption of specificcomponents to the sealant layer
Contents
Contents
Contents
in container
in container
in container

ActiveActivePharmaceuticalPharmaceutical
ActiveIngredientIngredient
Pharmaceutical
IngredientContact
Contact
surfacesurface
Contact surface

Multilayer
Multilayer
olefinolefin
resinsresinsMultilayer olefin resins

Multilayer
Multilayer
olefinolefin
resinsresinsMultilayer olefin resins

NI layer
NI (druglayer (drugcontact)
contact)
NI layer (drug contact)

NI layer
NI layer
NI layer

Drug contents
Drug contents
Drug contents

OlefinOlefinsealantsealant(drug (drugcontact)contact)
Olefin sealant (drug contact)

OtherOther
Othercontainers
containers
containers

NI film
NI film
NI film

Drug contents
Drug contents
Drug contents

Protects against potential
extractables migrating
across film layers

Protects against potential
extractables migrating
across film layers

High purity
grades ofolefin available

NI layer minimizes sorptionof active ingredients!

Glass-like shelf life performance
Performance data shows that our MediTect™ bags maintain the potency of active ingredients of drug
solutions over time by the prevention of sorption effects comparable to glass container controls.
Nitroglycerin - treatment for Angina

Edaravone - treatment for Ischemic stroke

10010090908080707060
50〜〜

0Remaining
API (%)

60

Glass ampoule

50

NI inner layer〜〜

Olefin bag

Pre-autoclave

Post-autoclave

2 weeks

6 weeks

0Remaining
API (%)

Glass ampoule
NI inner layer
Olefin bag

Pre-autoclave

Post-autoclave

2 weeks

6 weeks

Based on ZACROS internal study

Contact us to discuss how ZACROS’ MediTect technology can provide
solutions to your most complex formulation challenges
https://meditect.zacros.co.jp/
TM

Chicago Office1821 Walden Office Square Suite 400
Schaumburg, IL 60173, USA
www.zacrosamerica.com

Corporate Headquarters

Bunkyo Garden Gate Tower, 22F
1-1-1 Koishikawa, Bunkyo-ku, Tokyo 112-0002, JAPANwww.zacros.co.jp/en/