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F R A U N H O F E R I N S T I T U T E F O R P R O c E S S E N g I N E E R I N g A N d PA c k A g I N g I V V

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Quality assurance of packagings for pharma-ceuticals and cosmetics A variety of demands are put on packaging

for pharmaceutical and cosmetic products.

The high quality of products, which

often have sensi tive contents, must be

guaranteed during the packaging and

sterilization as well as during storage and

after opening.

Requirements of industry

In order to select an optimum pack aging

system, manufacturers of pharmaceutical

packagings and cosmetic products and

companies which package pharmaceutical

and cosmetic prod ucts require infor mation

about the following:

Migration•

Materials from the polymer (monomer,

additives) or other auxiliary substances

used in the processing can transfer

from the packaging materials into the

contact media and so adversely affect

the properties of the properties of the

product. This applies in particular to

liquid solutions of active substances.

Permeation•

In the final packaged products the

concentration of active substances must

remain constant within the prescribed

period for use. For example, an etheric

oil in a plastic bottle must not lose its

smell after a few days.

compatibility•

with sterilization methods.

Packaging systems react differently to

dif ferent sterilization methods.

1 Blister packagings.

Fraunhofer Institute for

Process Engineering and

Packaging IVV

Giggenhauser Strasse 35

85354 Freising

Contact:

Dr. Frank Welle

Phone +49 8161 491-724

Fax +49 8161 491-777

[email protected]

www.ivv.fraunhofer.de

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Our offer

Determination of the permeability of •

packagings to gases and water.

Determination of the permeability of •

active substances through packagings.

Determination of the migration of ma-•

terials in polymers or radiolysis products

into contact media.

Testing the stability and/or concen-•

tration of the active substance in the

total system.

Evaluation of the compatibility of the •

packaging with various steril ization

methods.

Advice on the selection of suitable •

packaging materials regarding per -

meation, migration and the method of

sterilization.

Optimization of the barrier prop erties •

by application of special coatings.

Yourbenefit

You have access to a team with many •

years of experience in carrying out

permeation, migration and barrier

measurements.

The most important testing methods are •

accredited in accordance with DIN EN

ISO/IEC 17025.

Assurance for selecting packaging •

materials.

Packagings for pharmaceutical products •

can be purposefully optimized at an ea-

rly technological stage and be adapted

to the contents.

Existing packaging systems can also be •

optimized for particular needs.

This minimizes the development costs •

and time required, with at the same

time a higher quality for the packed

products.

1 Cosmetic packagings.