quality assurance of packagings for pharma- ceuticals and ... · pdf filefraunhofer institute...
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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
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.