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Biography
Erwin Pasbrig is a Chemist with
a PhD in organic chemistry (University for Chemistry Halle/Merseburg).
He is working since 1983 in the
field of packaging material with aluminium.
In his 16 years of service at
Alcan Packaging Singen, his responsibilities have included the supervision
of development and application technique packaging materials for
pharmaceutical products and 3 years was head of product management and
technical marketing Pharma/Cosmetic of Alcan Packaging Singen/Kreutzlingen.
Since 2005 in addition he is
director of R&D for Alcan Packaging – Pharmaceutical Packaging Europe.
Erwin holds more than 20
patents and presented papers regarding new developments of packaging
materials on different seminars around the world and speeches on university.
With his team he won awards on
different contest like the “Deutsche Verpackungswettbewerb”, “World Star of
Packaging” and the “EAFA”.
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Abstract
Sterilisation of
pharmaceutical and medical packaging can be carried out with a number of
available sterilisation processes. Current sterilisation processes can be
divided in to 3 main groups, heat or steam sterilisation, chemical
sterilisation und sterilisation through irradiation.
Gamma sterilisation and e-beam sterilisation are increasingly being used.
The justifications for this lie in the predominant advantages of gamma and
e-beam sterilisation versus EtO (ethylene oxide) sterilisation:
Simpler process control (sole process variables are: irradiation time and
doses level)
Immediate doses-metered release (no degassing cycle time, no biological
indicators required, no product quarantine)
Full penetration in to the product that is being sterilised (few
limitations to for example pack design)
Avoidance of any toxicity issues that might be incurred with Eto (ethylene
oxide) (remnants, emissions)
Prior to making any assessment on the effects of irradiation sterilisation
on the packaging a very clear distinction must be made between the
irradiation of a finished package as-sembly and reel feed stock. It should
be noted that reel feed stock in sterilisation is hardly ever used.
When irradiation sterilizing a finished assembled package the deterioration
ion the slip / friction properties no longer plays role, but the odours
emanating and created during the sterilizing process may preclude the
package from commercial use. This problem can be overcome or minimised with
the use of modified atmosphere within the package, the use such as inert
gasses (e.g. with PE the use of nitrogen).
A decline in the mechanical properties and mechanical strength of the
packaging could lead damage within and outside of the packaging during
transportation and product han-dling. (E.g. Push-through properties /
dent-resistance). Stress-fractures within the inner layer of the packaging
material could lead to product migration within the pack.
The changes to optical properties that can occur during irradiation
sterilisation are barely visible within the laminate and are only apparent
when compared directly to non-sterilized packages. Normally this is not an
issue.
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